Karl Storz Endoscopy America Inc

The device Instruction Manual recall, which includes: 1) Telescope, 2) Camera Head, and 3) Camera System.   Serial Numbers: ZZ2008 ZZ2016 ZZ2012 ZZ2019 TY2024 ZZ2013 TY2026 TY2025 TY2028 TY2021 ZZ2007 ZZ2020 TX2036 TX2033 ZZ2017, and  TX2035.

Gastroenterology-Urology Devices

3

No

Nationwide distribution: USA including states of: IL, CA, WV, TX, SC, WI, NY, PA, NE, NJ, MD, OH, IA, and NC.

KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, || Instruction Manuals: PDD Telescopes, Tricam SL II, and PDD Camera Heads. || Used as an optional accessory to white light cystoscopy when used in combination with the diagnostic imaging drug Cysview.

Lot 36836

Gastroenterology-Urology Devices

2

No

Distributed Nationwide and in Canada.

Electrode, VaporCut, 24FR (27050SG/6). || Resectoscope accessories (ie. electrode, cutting loops and cold knives).

Lot 36781

Gastroenterology-Urology Devices

2

No

Distributed Nationwide and in Canada.

Loop, Cutting, 24FR (26050G/6). || Resectoscope accessories (ie. electrode, cutting loops and cold knives).

Lot 36851

Gastroenterology-Urology Devices

2

No

Distributed Nationwide and in Canada.

Knife, Cold, Straight (27068K/6). || Resectoscope accessories (ie. electrode, cutting loops and cold knives).

Lot 36897

Gastroenterology-Urology Devices

2

No

Distributed Nationwide and in Canada.

Electrode, Cutting, 24FR, 0.30MM (27040G-.30/6). || Resectoscope accessories (ie. electrode, cutting loops and cold knives).