Class I — Ethicon, Inc.
| Recalling firm | ETHICON INC. |
|---|---|
| Registered facility | View this company's 11 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue within the packing process where a cut could potentially breach the double Tyvek pouch of the packaging. |
| Product | ETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON, Inc. Somerville, NJ 08876, USA SURGIFLO Hemostatic Matrix is a topical absorbable hemostat consisting of a flowable gelatin matrix (paste). This kit also contains components necessary for preparing and applying the matrix during surgery. SURGIFLO Hemostatic Matrix, mixed with sterile saline or thrombin solution, is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical. |
| Quantity | 45,200 |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Russia, China, and the European Union. |
| Initiated | 2012-08-21 |
| Classified | 2012-11-16 |
| Terminated | 2014-09-11 |
| Recall number | Z-0293-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Ethicon, Inc. (Z-0293-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63322/
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