CooperSurgical, Inc.: Medical Device Recalls in 2021

According to to data from the FDA, there were 11 medical device recalls made by CooperSurgical, Inc. in 2021. See the details of the recalls below.

You can see similar recalls for other firms.

• Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible w/Short Stem Pessary, REF MXKPGSS2-1/4, 2-1/4" (57 mm) with Kit, 2) Gellhorn Flexible w/Short Stem Pessary, REF MXPGSS2-1/4, 2-1/4" (57 mm) without Kit, 3) Gellhorn Flexible w/Short Stem Pessary, REF MXPGSS2-3/4, 2-3/4" (70 mm)
• Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Work Chamber 230V. [CooperSurgical part numbers K22400-110, K22200-110, K22400-230, K22200-230, K59500, K59700, K60000, 3.641.831.153, & 3.641.832.153].
• Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05
• LEEP PRECISION Generator 120V Cooper Surgical Part Number: LP-20-120
• The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not made with natural rubber latex. Model Number(s): KCP-30-2
• CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Disposable Universal Electrodes, LOOP electrodes, used for electro-excisional procedures, and for electro-fulguration procedures of the lower genital tract
• LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220
• Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075
• LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220
• LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120
• Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W