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Device Recall Natus neoBLUE 2 Phototherapy system
Device Recall ACCUCHEK Tender II Infusion Set
  • Model / Serial
    Catalog: 04541472001 and lots: 5053291 and 5078661.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    ACCU-CHEK Tender II 13/80 10 + 10 pieces || Product Usage: || Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary click-lock connector for the infusion of drugs subcutaneously. The infusion set can be detached from the indwelling catheter, and the catheter capped to allow freedom from the infusion set and pump for showers, athletics or other activities.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
  • 1 Event
Device Recall ACCUCHEK Tender II Infusion Set
  • Model / Serial
    Catalog: 04541456001 and lot: 5052067
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    ACCU-CHEK Tender II 13/110 10 + 10 pieces || Product Usage: || Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary click-lock connector for the infusion of drugs subcutaneously. The infusion set can be detached from the indwelling catheter, and the catheter capped to allow freedom from the infusion set and pump for showers, athletics or other activities.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
  • 1 Event
Device Recall ACCUCHEK Tender II Infusion Set
  • Model / Serial
    Catalog: 04541502001 and lots: 5044353, 5046676, 5053301, and 5061934.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    ACCU-CHEK Tender II 17/60 10 + 10 pieces || Product Usage: || Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary click-lock connector for the infusion of drugs subcutaneously. The infusion set can be detached from the indwelling catheter, and the catheter capped to allow freedom from the infusion set and pump for showers, athletics or other activities.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
  • 1 Event
Device Recall ACCUCHEK Tender II Infusion Set
  • Model / Serial
    Catalog: 04541529001 and lots: 5044354, 5051306, 5058507, and 5062209.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    ACCU-CHEK Tender II 17/80 10 + 10 pieces || Product Usage: || Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary click-lock connector for the infusion of drugs subcutaneously. The infusion set can be detached from the indwelling catheter, and the catheter capped to allow freedom from the infusion set and pump for showers, athletics or other activities.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
  • 1 Event
Device Recall ACCUCHEK Tender II Infusion Set
  • Model / Serial
    Catalog: 04541499001 and lots: 5051307, 5061935, and 5078667.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    ACCU-CHEK Tender II 17/110 10 + 10 pieces || Product Usage: || Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary click-lock connector for the infusion of drugs subcutaneously. The infusion set can be detached from the indwelling catheter, and the catheter capped to allow freedom from the infusion set and pump for showers, athletics or other activities.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
  • 1 Event
Device Recall Getinge 46Series Medical WasherDisinfector
  • Model / Serial
    Serial Numbers: SEV0810077, SEV0537108, SEV0633084, W50030454, SEV0724143, SEV0724146, SEV0609110, W50044787, SEV0533068, W50042461, W50023731, W50023732, W50038744, W50028760, SEV0802081, W50015468, W50042473, W50045852, W50048201, W50041156, SEV0911139, SEV0832021, W50031347, SEV0538174, SEV0910190, SEV0734181, W50033518, SEV0802083, W50043877, W50015494, W50047828, SEV0633086, SEV0647025, SEV0650003, SEV0650004, SEV0534069, SEV0617130, W50011492, SEV0538177, W50010176, W50027826, SEV0743108, W50012356, SEV0614021, W50039525, SEV0619121, W50021052, W50025573, W50024233, W50010768, SEV0827061, SEV0738121, SEV0804079, SEV0806117, SEV0820063, SEV0820064, W50041988, SEV0727015, SEV0739202, SEV0906031, SEV0814068, SEV0805187, W50050381, W50050415, SEV0808424, SEV0626127, SEV0645102, SEV0710062, SEV0802086, SEV0815031, SEV0815032, W50027223, W50027224, SEV0826158, W50027541, W50043237, SEV0906032, W50012254, W50038229, W50014011, W50013832, W50012253, W50036280, W50036309, W50048577, SEV0537107, SEV0842075, SEV0750143, W50016365, SEV0808427, SEV0724139, SEV0724145, W50038722, SEV0908129, SEV0908130, SEV0649007, W50023502, SEV0842076, SEV0808429, SEV0837132, SEV0827051, W50027618, SEV0705085, SEV0705084, SEV0705083, W50026375, W50023804, W50014025, SEV0742115, W50028434, W50040964, W50019155, W50010908, W50013646, W50036143, W50045596, W50029312, W50029313, SEV0806118, W50028808, W50045860, W50014993, SEV0636055, SEV0738120, W50050491, W50028245, W50035227, W50048232, SEV0626230, W50023210, W50030137, SEV0808430, SEV0724144, SEV0534064, WAA053021, W50041067, W50030350, SEV0540080, W50045855, W50032192, W50029835, W50031507, SEV0739208, SEV0802085, SEV0622093, SEV0650002, SEV0619122, W50016086, W50039500, SEV0543058, SEV0910191, SEV0837135, W50018212, SEV0537103, WAA052845, SEV0605066, W50034170, SEV0524337, W50011160, W50011491, W50032801, W50015395, W50042391, SEV0547204, W50045890, W50047809, W50013644, W50013645, W50030121, W50021208, SEV0626228, SEV0851034, SEV0827047, SEV0552041, W50037851, SEV0833107, SEV0833108, SEV0833109, SEV0833110, SEV0833111, W50036056, W50036081, SEV0837131, W50015490, SEV0716176, SEV0716177, W50043774, W50023888, SEV0738132, SEV0827050, SEV0724140, W50015641, W50045601, W50024979, SEV0614035, W50016223, W50025076, SEV0815030, SEV0820065, W50016368, SEV0647023, SEV0909043, W50037190, SEV0642143, W50017770, SEV0537110, SEV0543054, SEV0538178, W50023488, SEV0614036, SEV0614037, SEV0533067, W50029860, W50029036, SEV0814067, SEV0851035, SEV0851036, W50013647, SEV0738001, SEV0739204, SEV0810081, SEV0533069, W50016222, SEV0906030, W50014012, W50019465, W50038218, SEV0521190, W50038730, SEV0826159, W50012251, SEV0738133, SEV0619119, SEV0649010, SEV0619120, SEV0614022, W50050577, W50041166, W50048183, W50017921, SEV0739205, SEV0749123, W50042459, SEV0524338, SEV0820049, SEV0640030, W50030144, W50030181, W50028247, W50014027, W50032581, W50013666, W50042946, W50045884, W50050574, W50013831, SEV0618050, SEV0618051, SEV0727034, SEV0534074, SEV0716188, W50010079, W50033538, W50047210, W50019156, W50032618, W50015495, W50036207, SEV0733024, W50021211, SEV0827056, W50043040, W50028248, W50028468, SEV0605063, SEV0815025, SEV0824064, SEV0808426, W50036147, W50017918, W50018215, W50030353, W50036140, WAA053036, SEV0724142, SEV0533065, W50035801, SEV0907057, W50045822, SEV0836007, W50028320, W50010906, W50028809, W50023209, W50048247, W50027514, SEV0739206, SEV0739209, SEV0626231, SEV0738131, W50038686, W50011489, W50011490, W50046986, SEV0633083, W50021142, SEV0907054, W50021143, SEV0716048, W50023897, SEV0907055, W50011159, SEV0647022, SEV0851037, SEV0907056, W50021141, SEV0826157, SEV0848144, SEV0621158, W50047960, SEV0633088, SEV0705086, SEV0727019, SEV0626121, SEV0626229, W50010177, SEV0738122, SEV0738123, SEV0521184, W50016376, SEV0633087, W50019467, W50015466, W50017920, W50033104, W50025852, W50016366, SEV0632078, SEV0543059, W50048551, W50035559, SEV0521191, SEV0515157, SEV0515159, SEV0548037, SEV0644133, SEV0727032, SEV0820048, SEV0844215, SEV0906028, SEV0906029, W50010905, W50015493, W50037099, W50037204, W50039512, W50042471, W50042478, W50050571,  W50050573, W50050578, WAA053175, SEV0618048, SEV0545170, SEV0724147, SEV0632079, SEV0827060, SEV0743107, SEV0820057, SEV0826160, W50029023, SEV0524334, W50011161, W50022983, W50045665, W50048002, W50012252, W50018216, W50018928,  W50019154, SEV0734183, W50050575, SEV0820050, W50027512, SEV0716185, SEV0820058, W50041125, SEV0605064, SEV0615074, SEV0649008, SEV0622094, W50016364, SEV0737120, W50038421, SEV0824063, W50017919, SEV0815033, W50033839, SEV0626126, SEV0808428, W50015496, SEV0533071, W50023733, SEV0716184, SEV0742118, SEV0727033, SEV0649009, SEV0810078, W50039166, SEV0618049, W50038256, SEV0536194, SEV0716183, SEV0613001, W50042222, W50043233, SEV0636042, SEV0636043, W50039286, W50017771, SEV0804077, SEV0633085, W50021356, W50021357, SEV0532062, W50020918, W50030145, W50038244, W50036145, SEV0626120, SEV0716175, W50023501, SEV0733032, SEV0734182, SEV0738002, W50010907, W50037207, SEV0708018, W50048219, W50014030, SEV0626234, SEV0738130, W50042491, SEV0543056, SEV0536195, SEV0543055, W50013311, W50028993, SEV0739203, SEV0613098, SEV0739207, SEV0647024, W50035975, SEV0708019, SEV0702017, SEV0805191, SEV0521192, SEV0910192, W50041173, SEV0842074, W50021214, SEV0723112, W50037115, SEV0833100, SEV0833101, SEV0833102, SEV0833103, SEV0833104, W50017914, W50024126, W50029644, SEV0637017, SEV0605065, SEV0724138, W50037201, SEV0536197, W50045549, W50048239, W50011158, SEV0834133, SEV0708020, SEV0710061, SEV0849100, W50017917, W50030122, W50023198, W50018213, W50018214, SEV0533070, SEV0612048, SEV0632080, SEV0727018, SEV0537104, SEV0524333, W50024980, SEV0808423, SEV0734180, W50024130, W50024131, SEV0626125, W50035799, W50015488, SEV0827046, SEV0613100, SEV0615042, SEV0637018, SEV0543057, SEV0810080, W50021145, SEV0548036, SEV0606022, W50028246, W50028112, W50028113, W50027222, W50033877, SEV0908131, W50029035, SEV0827045, W50024981, SEV0521186, SEV0538173, SEV0827057, W50013312, SEV0626232, SEV0613099, W50016367, SEV0626233, W50018929, SEV0911140, SEV0911141, W50015398, SEV0521187, W50041062, SEV0524327, WAA052236, SEV0910189, W50021210, W50030183, SEV0804078, SEV0808425, SEV0626119, SEV0724141, W50047838, W50015491, SEV0643166, SEV0802082 --- Canadian Units: SEV0538175, SEV0613101, W50030182, W50030412.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed US (nationwide) and the country of Canada.
  • Product Description
    GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Control Series with dryer --- Class II, exempt from 510(k) requirements. || For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
  • Manufacturer
    Getinge Disinfection Ab
  • 1 Event
Device Recall SoftPath
  • Model / Serial
    Version 4.3.0.8 Release date: 07/31/2009 - Present;  Version 4.3.0.9 Release date: 11/23/2009 - Present;  Version 4.3.0.10 Release date: 09/20/2010- Present;  Version 4.3.0.11 Release date: 11/11/2010- Present;  Version 4.3.0.12 Release date: 02/07/2011- Present; Version 4.3.0.14 Release date: 11/14/2012- Present;  Version 4.3.0.15 Release date: 09/17/2013- Present;  Version 4.4.0.1 Release date: 12/13/2013 - Present;
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distribution US Nationwide and CANADA.
  • Product Description
    SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10, 4.3.0.11, 4.3.0.12, 4.3.0.14, 4.3.0.15, and 4.4.0.0
  • Manufacturer
    SCC Soft Computer
  • 1 Event
Device Recall LUNA Chest, Model No. LU4006
  • Model / Serial
    Kit Lot Numbers: 13116, 14012, 14017, 14056, 14074, 14103, 14107 Drape Lot Numbers: D132172, D132602, D162692, D132602, D132712, D141002, D130282
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to IA, LA, GA, MD, ID, FL, TN, OH, TX, NC, MA, KY, KS, WI, IN, SC, OR, CT, CA, WA, PA, OK, and PR.
  • Product Description
    LUNA Chest, Model No. LU4006
  • Manufacturer
    Novadaq Technologies, Inc.
  • 1 Event
Device Recall LUNA Paq, Model No. LU3006
  • Model / Serial
    Kit Lot Numbers: 14082, 14091, 14104, 14106 Drape Lot Numbers: D132712, D133102, D141022, D130282
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to IA, LA, GA, MD, ID, FL, TN, OH, TX, NC, MA, KY, KS, WI, IN, SC, OR, CT, CA, WA, PA, OK, and PR.
  • Product Description
    Non-sterile drape
  • Manufacturer
    Novadaq Technologies, Inc.
  • 1 Event
Device Recall PKG, BIPOLAR FORCEPS, MICRO TIP
  • Model / Serial
    Serial/Lot 0915269/0817086 1015777 1016562/1015776 111333/1015777 111333-1015777
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
  • Product Description
    PKG, BIPOLAR FORCEPS, MICRO TIP, 45CM, P/N 0250080115 || nationwide in US and worldwide: Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Venezuela
  • Manufacturer
    Stryker Endoscopy
  • 1 Event
Device Recall PKG, BIPOLAR FORCEPS, FENESTRATED
  • Model / Serial
    Serial/Lot 06CON06110 06CON06111 0816588/0816395 0816693/0816395 0913442/0817444 0913984/1014813 0914894/1013609 0914894/1014814 0914894/1016062 0914894/1016825 0915431/1016825 1015779/0914894 1016736/1114541 1016739/1016398 1016739/1113020 1016739/1114541 1016846/1114541 1113331/1115651 1113332/1115651 1114831/1115651 1115971/1213123 1116462/1213123 1116463/1213978 1116463/1213979 1314474/1314476
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
  • Product Description
    PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080120 || Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
  • Manufacturer
    Stryker Endoscopy
  • 1 Event
Device Recall PKG, BIPOLAR FORCEPS, PADDLE
  • Model / Serial
    Serial/Lot 3282011 06CON06112 817085 0817438/0817442 0817439/0817442 0913442/0913326 0913442/0913523 0913544/0913523 0913581/0913523 0913812/0817492 0913812/0914227 0913812/0915061 0914894/1015779 0915431/1016063 1016560/1016063 1016560/1016826 1016847/1117011 1115970/1117011 1115971/1117011 1116463/1216149 1216408/1216149 1216409/1216149 1216409/1313046 1216409/1313047 1216409/1313048 1216409/1313946 1216720/1313946 913442/913523
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
  • Product Description
    PKG, BIPOLAR FORCEPS, PADDLE, 33CM, P/N 0250080121 || Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
  • Manufacturer
    Stryker Endoscopy
  • 1 Event
Device Recall PKG, BIPOLAR FORCEPS, MICRO TIP
  • Model / Serial
    0814958/0814844 0816249/0816241
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
  • Product Description
    PKG, BIPOLAR FORCEPS, MICRO TIP, 33CM, P/N 0250080122 || Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
  • Manufacturer
    Stryker Endoscopy
  • 1 Event
Device Recall PKG, BIPOLAR FORCEPS, FENESTRATED
  • Model / Serial
    06CON06113 0816243/0817410 0913221/0817442 0913222/0817442 1015164/1014813 1015164/1015778 1016405/1016061 1016405/1016400 1016405/1016401 1113335/1113339 1213126/1114543 1213127/1114543 1213127/1213123 1214001/1313047 1313947/1313946 0817389/0817444 0913565/0913326 0915791/0915061 0915791/1013608 0915894/0915061 0915895/0915061 1014635/1015778 1015165/1013609 1015165/1015778 1015773/1015778 1015774/1015778 1015862/1016061 1016124/1016061 1016125/1016062 1016128/1016061 1016406/1016400 1016408/1016400 1016408/1016826 1016562/1016400 1113333/1016063 1113333/1113018 1113333/1113136 1113333/1113339 1115969/1115651 1116112/1115651 1116113/1115651 1116114/1115651 1116115/1115651 1116256/1115651 1213128/1213731 1213973/1213978 1213974/1213731 1213974/1213978
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
  • Product Description
    PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080123 || Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
  • Manufacturer
    Stryker Endoscopy
  • 1 Event
Device Recall PKG, OPBIOPSY FORCEPS, SPOON JAW
  • Model / Serial
    06CON06089 06CON06321
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
  • Product Description
    PKG, OP-BIOPSY FORCEPS, SPOON JAW, P/N 0250080007 || Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
  • Manufacturer
    Stryker Endoscopy
  • 1 Event
Device Recall PKG, FIXATION CLAMP 5MM WITH RATCHET
  • Model / Serial
    542650 744316 746309 746656 840349 845864 940057 940150 940431 942656 944708 945457 1040794 1041288 1043107 1043115 1045071 1046601 1140168 1142891 1143157 1143970 1144494 1144654 1146465 1146836 1147098 1241415 1242117 1242944 1245442 1245450 1340115 1341560 1341562 1343425 1344136 1441095 790382
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
  • Product Description
    PKG, FIXATION CLAMP 5MM WITH RATCHET, P/N 0250080130 || Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
  • Manufacturer
    Stryker Endoscopy
  • 1 Event
Device Recall PKG, KNOT PUSHER 5MM OPEN
  • Model / Serial
    443530 940772 941380 942132 942251 1040526 1041289 1042465 1043108 1043109 1043110 1044455 1045026 1046385 1140655 1141210 1141782 1142627 1143074 1143156 1144548 1145353 1146980 1147097 1240543 1242451 1243364 1244180 1246138 1246145 1340556 1341561 1342150 1343019 1343312 1343417 1346108 1346431 1440890 1441386
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
  • Product Description
    PKG, KNOT PUSHER 5MM OPEN, P/N 0250080132 || Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
  • Manufacturer
    Stryker Endoscopy
  • 1 Event
Device Recall PKG, MYOMA DRILL
  • Model / Serial
    38288 39507 39846 40596 41522 48721 51894 55738 56804 57850 58578 60020 61032 62762 63483 66607 75625 79115 79265 81515
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
  • Product Description
    PKG, MYOMA DRILL 5MM LENGTH 320MM, P/N 0250080133 || Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
  • Manufacturer
    Stryker Endoscopy
  • 1 Event
Device Recall PKG, PALPATION PROBE GRADUATED
  • Model / Serial
    11065 12295 36062 38692 38692S 39653 39653Q 40941 41940 45715 47498 48553 53027 57438 59018 61549 65595 67460 68636 69943 71159 71690 72430 73104 73143 76287 78164 81388 82391 83206 84297
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
  • Product Description
    PKG, PALPATION PROBE GRADUATED 5MM, P/N 0250080135; || Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
  • Manufacturer
    Stryker Endoscopy
  • 1 Event
Device Recall PKG, PORTIO ACORN SMALL ONLY
  • Model / Serial
    34504 35874 36526 39114 41754 43588 44933 45493 47090 47110 48141 48644 58733 71066 71696 73836 78683 80420 83082 35298 36525 37553 38130 45247 47804 48542 50949 76176 76645 76892 82553 83081 84279
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
  • Product Description
    PKG, PORTIO ACORN SMALL ONLY, P/N 0250080139; || Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
  • Manufacturer
    Stryker Endoscopy
  • 1 Event
Device Recall PKG, TROCAR 5.5MM PYRAMIDAL TIP
  • Model / Serial
    197 38131 38747 39045 39817 40278 44522 44930 44975 45335 45696 46073 46627 47127 47522 48166 48223 48343 48647 48697 48906 50041 50897 51785 51847 52851 55571 55760 56637 57449 59208 59912 61503 62135 63265 64479 66886 67927 69680 70038 70468 74244 75610 76094 76272 76376 76880 78068 81392 81963 83190 83798 84017 84488 87567 89064
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
  • Product Description
    PKG, TROCAR 5.5MM PYRAMIDAL TIP, P/N 0250080154; || Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
  • Manufacturer
    Stryker Endoscopy
  • 1 Event
Device Recall PKG, OBTURATOR, 5.5MM FOR HASSON CANNULA
  • Model / Serial
    37302 37858 39543 45622 48347 48903 49147 49148 75351 77384 79474 79610 82402 85050 86167 86294
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
  • Product Description
    PKG, OBTURATOR, 5.5MM FOR HASSON CANNULA, P/N 0250080157; || Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
  • Manufacturer
    Stryker Endoscopy
  • 1 Event
Device Recall PKG, CANNULA 5.5MM AUTOMATIC VALVE STOP COCK W/O TROCAR
  • Model / Serial
    35499 38198 38758 39650 39650N 40110 40250 43627 44955 44976 45866 46024 46320 46396 46710 46802 47210 47389 47513 47750 47970 48066 48398 48762 48965 49494 49498 49612 49834 50168 50430 50722 50855 50920 51536 52647 52919 53043 53136 53515 53795 53972 55872 58336 58821 59615 60227 60752 62482 64133 64678 64965 65640 67422 67737 68342 69272 71077 75257 75918 76080 76460 76831 76960 77711 78491 79425 82007 82916 83532 83926 85069 85467 85909 86149 86265 86430 86539 86869 87496 89088 89441
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
  • Product Description
    PKG, CANNULA 5.5MM AUTOMATIC VALVE STOP COCK W/O TROCAR, P/N 0250080171. || Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
  • Manufacturer
    Stryker Endoscopy
  • 1 Event
Device Recall PKG, MARYLAND FORCEPS, CURVED
  • Model / Serial
    06CON06090 06CON06322
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
  • Product Description
    PKG, MARYLAND FORCEPS, CURVED, P/N 0250080009. || Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
  • Manufacturer
    Stryker Endoscopy
  • 1 Event