Cooper Surgical, Inc.

Serial Number Prefixes of Affected Product: A, AN,DN, EN, FA, JN, LN, 03, 04, 07, 08, 09,11,12

General and Plastic Surgery Devices

2

No

Worldwide Distribution -- United States, Canada, Australia, Belgium, England, France, Germany, Greece, Hungary, Iceland, Italy, Ireland, Latvia, Lithuania, Netherlands, Portugal, Spain, Solvenia, Sweden, Hong Kong, Republic of China, Taiwan, Angola, Cameroon, Congo, Croatia, Egypt, Ghana, Guam, Guineae Bissau, Indonesia, Kenya, Kuwait, Lebanon, Madagascar, Mali, Mauritania, Mozambique, New Zealand, Niger, Pakistan,Qatar, Russia, Sao Tome, Saudi Arabia, Senegal, Serbia, Singapore, South Africa, St Vincents & Grenadines, Oman, Thailand, Turkey, UAE and Zimbabwe.

Wallach LL100 Cryosurgical Freezer CO2 Unpinned Yoke System CO2 || Model: 900000.

Serial Number Prefixes of Affected Product: A, FA, 02,03, 04, 05,06, 07, 08, 09, 10,11

General and Plastic Surgery Devices

2

No

Worldwide Distribution -- United States, Canada, Australia, Belgium, England, France, Germany, Greece, Hungary, Iceland, Italy, Ireland, Latvia, Lithuania, Netherlands, Portugal, Spain, Solvenia, Sweden, Hong Kong, Republic of China, Taiwan, Angola, Cameroon, Congo, Croatia, Egypt, Ghana, Guam, Guineae Bissau, Indonesia, Kenya, Kuwait, Lebanon, Madagascar, Mali, Mauritania, Mozambique, New Zealand, Niger, Pakistan,Qatar, Russia, Sao Tome, Saudi Arabia, Senegal, Serbia, Singapore, South Africa, St Vincents & Grenadines, Oman, Thailand, Turkey, UAE and Zimbabwe.

Wallach LL100 Cryosurgical Freezer CO2 System || Model: 9000002X.

Serial Number Prefixes of Affected Product: A, X, 10

General and Plastic Surgery Devices

2

No

Worldwide Distribution -- United States, Canada, Australia, Belgium, England, France, Germany, Greece, Hungary, Iceland, Italy, Ireland, Latvia, Lithuania, Netherlands, Portugal, Spain, Solvenia, Sweden, Hong Kong, Republic of China, Taiwan, Angola, Cameroon, Congo, Croatia, Egypt, Ghana, Guam, Guineae Bissau, Indonesia, Kenya, Kuwait, Lebanon, Madagascar, Mali, Mauritania, Mozambique, New Zealand, Niger, Pakistan,Qatar, Russia, Sao Tome, Saudi Arabia, Senegal, Serbia, Singapore, South Africa, St Vincents & Grenadines, Oman, Thailand, Turkey, UAE and Zimbabwe.

Wallach LL50x Cryosurgical Freezer CO2 System || Model: 900007.

Serial Number Prefixes of Affected Product: A, FA, 02, 05, 06, 10,08

General and Plastic Surgery Devices

2

No

Worldwide Distribution -- United States, Canada, Australia, Belgium, England, France, Germany, Greece, Hungary, Iceland, Italy, Ireland, Latvia, Lithuania, Netherlands, Portugal, Spain, Solvenia, Sweden, Hong Kong, Republic of China, Taiwan, Angola, Cameroon, Congo, Croatia, Egypt, Ghana, Guam, Guineae Bissau, Indonesia, Kenya, Kuwait, Lebanon, Madagascar, Mali, Mauritania, Mozambique, New Zealand, Niger, Pakistan,Qatar, Russia, Sao Tome, Saudi Arabia, Senegal, Serbia, Singapore, South Africa, St Vincents & Grenadines, Oman, Thailand, Turkey, UAE and Zimbabwe.

Wallach LL100 Cryosurgical Freezer No Gas Fitting CO2 System || Model: 900019x.

Serial Number Prefixes of Affected Product: A, IC

General and Plastic Surgery Devices

2

No

Worldwide Distribution -- United States, Canada, Australia, Belgium, England, France, Germany, Greece, Hungary, Iceland, Italy, Ireland, Latvia, Lithuania, Netherlands, Portugal, Spain, Solvenia, Sweden, Hong Kong, Republic of China, Taiwan, Angola, Cameroon, Congo, Croatia, Egypt, Ghana, Guam, Guineae Bissau, Indonesia, Kenya, Kuwait, Lebanon, Madagascar, Mali, Mauritania, Mozambique, New Zealand, Niger, Pakistan,Qatar, Russia, Sao Tome, Saudi Arabia, Senegal, Serbia, Singapore, South Africa, St Vincents & Grenadines, Oman, Thailand, Turkey, UAE and Zimbabwe.

Wallach LL100 Cryosurgical Freezer Short Shaft CO2 System || Model: 900034.