ETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON… recallZ-0293-2013 · Ethicon, Inc. · initiated Aug 21, 2012
Class I Terminated All recalls posted in November 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ethicon, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Packaging
What the company is doing
Ethicon Inc. sent an Urgent Product Information letter dated August 21, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory to determine if they have any of the affected product. Affected product should be returned for replacement to Stericycle using the enclosed pre-paid shipping label. Customers with questions should call 1-877-384-4266 or contact their Ethicon Biosurgery Sales Representative. For questions regarding this recall call 877-384-4266.
Recall details
- Recall number
- Z-0293-2013
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- Aug 21, 2012
- Posted by the FDA
- Nov 16, 2012
- Recalling firm
- Ethicon, Inc.
- Quantity
- 45,200
- Product code
- LMF
- FDA submissions
- P990004
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Russia, China, and the European Union.
Product description
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.
Code information (models, lots, serial numbers)
PMA number P990004 Medical Device Listing Number D100622 Product Code: 2991 Lot # 239091 Exp Mar-13 Lot # 238783 Exp Sep-13 Lot # 238635 Exp Mar-13 Lot # 237498 Exp Mar-13 Lot # 237119 Exp Mar-13 Lot # 235488 Exp Jan-13
Other devices under the same FDA submission
11 devices cleared under P990004 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- SURGIFLO® Hemostatic Matrix Kit with Thrombin 2994Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based1 recall42 reports
- SURGIFOAM® Absorbable Gelatin Powder Kit 1979Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based1 recall2 reports
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. 1972Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based24 reports
- SURGIFLO® Hemostatic Matrix 2991Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based17 reports
- SURGIFLO™ Hemostatic Matrix Kit with Thrombin SF2995Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based4 reports
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. 1974Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based2 reports
- SURGIFOAM® Absorbable Gelatin Powder 1978Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based2 reports
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. Oral Sponge 1969Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based1 report
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. 1973Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based1 death1 report
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. 1975Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based1 report
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. Hemorrhoidectomy Sponge 1977Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 63322).
- Z-0292-2013 · TerminatedETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc. Somerville, NJ 08876 USA Ref 2993 SURGIFLO Hemostatic Matrix, mixed wit…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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