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SURGIFOAM® Absorbable Gelatin Powder 1978Recalls & reported problems

Ferrosan Medical Devices A/S · Class 3 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15712123000240), received between Sep 25, 2020 and Sep 25, 2020 — classified as 2 injuries.

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.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2

Patient problems

  • Hematoma2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjurySep 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL FUSION PROCEDURE ON (B)(6) 2018 AND ABSORBABLE HEMOSTAT WAS USED. THE PATIENT WAS BROUGHT BACK TO THE OR FOR HEMATOMA EVACUATION ON (B)(6) 2018, SINCE THE PATIENT HAD A HEMATOMA POST OP. THE PATIENT IS FINE NOW AND AT HOME. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: Hematoma

    MAUDE report 10589463 ↗
  • InjurySep 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL FUSION PROCEDURE ON (B)(6) 2018 AND A ABSORBABLE HEMOSTAT WAS USED. THE PATIENT HAD TO BE BROUGHT BACK TO THE OR FOR HEMATOMA EVACUATION ON (B)(6) 2018, SINCE THE PATIENT HAD A HEMATOMA POST OP. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: Hematoma

    MAUDE report 10589457 ↗

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, Classified
    SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
  • Z-1584-2022 · May 25, 2022 · Open, Classified
    Ethicon 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-0293-2013 · Aug 21, 2012 · Terminated
    ETHICON 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-0292-2013 · Aug 21, 2012 · Terminated
    ETHICON 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-1897-2012 · Apr 3, 2012 · Terminated
    Ethicon 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

All Agent, Absorbable Hemostatic, Collagen Based devices →

Sources and updates

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