SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. 1975Recalls & reported problems
Ferrosan Medical Devices A/S · Class 3 · Implant
All models of SURGIFOAM Absorbable Gelatin Sponge, U.S.P. (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15712123000202), received between Jun 5, 2026 and Jun 5, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).
5 other recalls cover devices cleared under the same FDA submission (P990004); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2026Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE GELATIN WAS USED. THE DEVICE WAS OPENED FOR A CASE AND THE SURGICAL TECH NOTICED THAT THERE WAS A HAIR ON THE ABSORBABLE GELATIN PAD. THE ABSORBABLE GELATIN WAS PASSED OFF THE FIELD AND DID NOT COME IN CONTACT WITH THE PATIENT OR THE BACK TABLE. THEY OPENED A NEW 1975 ABSORBABLE GELATIN PAD TO REPLACE THE ONE WITH THE HAIR ON IT. NO DELAY OR PATIENT HARM WAS REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25410544 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P990004. One submission often covers many models, so check the product and lot details in each record.
- Z-1881-2024 · Apr 23, 2024 · Open, ClassifiedSURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
- Z-1584-2022 · May 25, 2022 · Open, ClassifiedEthicon SURGIFLO Hemostatic Matrix Kit with Thrombin (6/CS) Ref: 2994 Mfg: FERROSAN MEDICAL DEVICES A/S Indicated in surgical procedures (other than ophthalmic) as an adjunct
- Z-0292-2013 · Aug 21, 2012 · 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
- Z-0293-2013 · Aug 21, 2012 · TerminatedETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON, Inc. Somerville, NJ 08876, USA SURGIFLO Hemostatic Matrix is a topical absorbable hemostat consisting of a flo
- Z-1897-2012 · Apr 3, 2012 · TerminatedEthicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip Distributed by Ethicon Ethicon Inc., Somerville, NJ 08876 USA Manufactured by Ferrosan Medical Devices Ferrosan
Other Agent, Absorbable Hemostatic, Collagen Based devices
- 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
- Avitene 1050030Davol Inc. · Agent, absorbable hemostatic, collagen based1 recall1 report
- 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
- Avitene 1010090Davol Inc. · Agent, absorbable hemostatic, collagen based7 reports
- Avitene 1010020Davol Inc. · Agent, absorbable hemostatic, collagen based7 reports
- SURGIFLO™ Hemostatic Matrix Kit with Thrombin SF2995Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based4 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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