ETHICON, INC.

9 FDA enforcement actions

9 Total Recalls

0 Class I

9 Class II

0 Class III

Firm Details

Product Types: device
States: N/A, NJ

All Recalls

Class II: Risk 10/08/2024 device

Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
Class II: Risk 09/25/2024 device

Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package.
Class II: Risk 05/10/2024 device

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Class II: Risk 05/10/2024 device

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Class II: Risk 05/10/2024 device

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Class II: Risk 05/10/2024 device

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Class II: Risk 05/10/2024 device

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Class II: Risk 05/10/2024 device

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Class II: Risk 04/23/2024 device

Some applicator tips from these lots had open seals.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.