ETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON — Class I medical device recall Z-0293-2013
Terminated recall by Ethicon, Inc., reported 2012-11-28, distributed nationwide. SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue within the packing
| Recall number | Z-0293-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon, Inc., Somerville, NJ, United States |
| Recall initiated | 2012-08-21 |
| Classified | 2012-11-16 |
| Reported by FDA | 2012-11-28 |
| Terminated | 2014-09-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | CN, RU |
| Quantity | 45,200 |
| Lot numbers | 235488, 237119, 237498, 238635, 238783, 239091, JAN-13, MAR-13, SEP-13 |
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.
Reason for recall
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.
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-0293-2013. 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.