Company
ETHICON INC.
5 recall(s) on record — most severe on record: Class II.
| Owner-operator number | 9068641 |
|---|---|
| Registered facilities | 1 |
| Recalls on record | 5 |
Registered facilities (1)
- Johnson & Johnson do Brasil Ind. Com. de Prod. p/ Saude Ltda FEI 3004903580 · BR
Recalls & enforcement
- Class IIOngoing2024-10-08Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
- Class IIOngoing2024-09-25Complaints 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 IIOngoing2024-05-10Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
- Class IIOngoing2024-03-08Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
- Class IIOngoing2023-03-31Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be achieved
Watch this supplier
We'll email you when a new FDA recall or enforcement record is published for a facility you follow. (Inspection & warning-letter coverage is being added.)
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.