EVARREST Fibrin Sealant Patch — Class II medical device recall Z-1996-2016
Terminated recall by Ethicon, Inc., reported 2016-06-22, distributed nationwide. Ethicon is recalling EVARREST Fibrin Sealant Patch because the characters "0-bad" were printed in the expirati
| Recall number | Z-1996-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon, Inc., Somerville, NJ, United States |
| Recall initiated | 2016-04-11 |
| Classified | 2016-06-15 |
| Reported by FDA | 2016-06-22 |
| Terminated | 2017-08-02 |
| Distributed | Nationwide (US) |
| Quantity | 228 units |
| Reason classes | labeling |
| Lot numbers | U01F012A |
Product
EVARREST Fibrin Sealant Patch, Manufactured by: Omrix Biopharmaceuticals, Ltd, Israel. Indicated for use with manual compression as an adjunct to hemostasis for control of bleeding during adult liver surgery and soft tissue bleeding in adults when control of bleeding by standard surgical methods of hemostasis is ineffective or impractical.
Reason for recall
Ethicon is recalling EVARREST Fibrin Sealant Patch because the characters "0-bad" were printed in the expiration date field on the foil pouch labels of the Fibrin Patch units instead of the valid expiration date (2016-12-28).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1996-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.