Drug recall
SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961
FDA recall event 94831 · Class II · Ethicon Sarl, a Johnson & Johnson Company
Key facts
| Event ID | 94831 |
|---|---|
| Recall numbers | Z-2406-2024, Z-2407-2024 |
| Recalling firm | Ethicon Sarl, a Johnson & Johnson Company |
| Product type | Devices |
| Products | SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961, SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging. |
| Initiation date | Jun 11, 2024 |
| Report date | Jul 24, 2024 |
| City | Neuchatel |
| Country | Switzerland |
| FEI number | 3003702646 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: