SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. 1972Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 15712123000158), received between Apr 23, 2019 and Sep 24, 2026 — classified as 24 injuries.

The most frequently reported specific device problem is “Defective Device” (14 reports).

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

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported by the account contact to the sales rep that the patient had an allergic reaction on the sponge of the device.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 50879951 ↗
• InjuryMar 20, 2020Therapeutic or Diagnostic Output Failure

  THIS REPORT COVERS PATIENT NO. 8 OUT OF 20. PLEASE REFER TO FDA REPORT NO.: 3008478369-2020-00001 (INTERNAL FERROSAN MEDICAL DEVICES A/S REPORT NO.: (B)(4)) FOR EVALUATION OF THIS EVENT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 9858869 ↗
• InjuryMar 4, 2020Defective Device

  THIS REPORT COVERS PATIENT NO. 20 OUT OF 20. PLEASE REFER TO FDA REPORT NO.: 3008478369-2020-00001 (INTERNAL FERROSAN MEDICAL DEVICES A/S REPORT NO.: (B)(4)) FOR EVALUATION OF THIS EVENT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 9785044 ↗
• InjuryMar 4, 2020Defective Device; Patient-Device Incompatibility

  THIS REPORT COVERS PATIENT NO. 17 OUT OF 20. PLEASE REFER TO FDA REPORT NO.: 3008478369-2020-00001 (INTERNAL FERROSAN MEDICAL DEVICES A/S REPORT NO.: (B)(4)) FOR EVALUATION OF THIS EVENT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 9785042 ↗
• InjuryMar 4, 2020Defective Device

  THIS REPORT COVERS PATIENT NO. 18 OUT OF 20. PLEASE REFER TO FDA REPORT NO.: 3008478369-2020-00001 (INTERNAL FERROSAN MEDICAL DEVICES A/S REPORT NO.: QN 200078684) FOR EVALUATION OF THIS EVENT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 9785041 ↗
• InjuryMar 4, 2020Insufficient Heating

  THIS REPORT COVERS PATIENT NO. 19 OUT OF 20. PLEASE REFER TO FDA REPORT NO: 3008478369-2020-00001 (INTERNAL FERROSAN MEDICAL DEVICES A/S REPORT NO: QN (B)(4)) FOR EVALUATION OF THIS EVENT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 9785040 ↗
• InjuryMar 4, 2020Defective Device

  THIS REPORT COVERS PATIENT NO. 16 OUT OF 20. PLEASE REFER TO FDA REPORT NO.: 3008478369-2020-00001 (INTERNAL FERROSAN MEDICAL DEVICES A/S REPORT NO.: (B)(4)) FOR EVALUATION OF THIS EVENT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 9785039 ↗
• InjuryMar 4, 2020Defective Device

  THIS REPORT COVERS PATIENT NO. 15 OUT OF 20. PLEASE REFER TO FDA REPORT NO.: 3008478369-2020-00001 (INTERNAL FERROSAN MEDICAL DEVICES (B)(4) REPORT NO.: (B)(4)) FOR EVALUATION OF THIS EVENT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 9785036 ↗
• InjuryMar 4, 2020Defective Device

  THIS REPORT COVERS PATIENT NO.14 OUT OF 20. PLEASE REFER TO FDA REPORT NO.: 3008478369-2020-00001 (INTERNAL FERROSAN MEDICAL DEVICES A/S REPORT NO.: QN 200078684) FOR EVALUATION OF THIS EVENT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 9785035 ↗
• InjuryMar 4, 2020Defective Device

  THIS REPORT COVERS PATIENT NO. 12 OUT OF 20. PLEASE REFER TO FDA REPORT NO.: 3008478369-2020-00001 (INTERNAL FERROSAN MEDICAL DEVICES A/S REPORT NO.: (B)(4) FOR EVALUATION OF THIS EVENT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 9785029 ↗
• InjuryMar 4, 2020Defective Device

  THIS REPORT COVERS PATIENT NO. 13 OUT OF 20. PLEASE REFER TO FDA REPORT NO: 3008478369-2020-00001 (INTERNAL FERROSAN MEDICAL DEVICES A/S REPORT NO: QN (B)(4)) FOR EVALUATION OF THIS EVENT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 9785027 ↗
• InjuryMar 4, 2020Defective Device

  THIS REPORT COVERS PATIENT NO. 9 OUT OF 20. PLEASE REFER TO FDA REPORT NO.: 3008478369-2020-00001 (INTERNAL FERROSAN MEDICAL DEVICES A/S REPORT NO.: QN 200078684) FOR EVALUATION OF THIS EVENT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 9784641 ↗
• InjuryMar 4, 2020Defective Device

  THIS REPORT COVERS PATIENT NO. 7 OUT OF 20. PLEASE REFER TO FDA REPORT NO.: 3008478369-2020-00001 (INTERNAL FERROSAN MEDICAL DEVICES A/S REPORT NO.: (B)(4)) FOR EVALUATION OF THIS EVENT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 9784634 ↗
• InjuryMar 4, 2020Defective Device; Patient-Device Incompatibility

  THIS REPORT COVERS PATIENT NO. 6 OUT OF 20. PLEASE REFER TO FDA REPORT NO: 3008478369-2020-00001 (INTERNAL FERROSAN MEDICAL DEVICES A/S REPORT NO: QN (B)(4)) FOR EVALUATION OF THIS EVENT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 9784632 ↗
• InjuryMar 4, 2020Defective Device

  THIS REPORT COVERS PATIENT NO. 5 OUT OF 20. PLEASE REFER TO FDA REPORT NO.: 3008478369-2020-00001 (INTERNAL FERROSAN MEDICAL DEVICES A/S REPORT NO.: (B)(4)) FOR EVALUATION OF THIS EVENT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 9784630 ↗
• InjuryMar 4, 2020Defective Device

  THIS REPORT COVERS PATIENT NO. 4 OUT OF 20. PLEASE REFER TO FDA REPORT NO.: 3008478369-2020-00001 (INTERNAL FERROSAN MEDICAL DEVICES A/S REPORT NO.: QN (B)(4)) FOR EVALUATION OF THIS EVENT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 9784625 ↗
• InjuryMar 4, 2020Defective Device; Patient-Device Incompatibility

  THIS REPORT COVERS PATIENT NO. 3 OUT OF 20. PLEASE REFER TO FDA REPORT NO.: 3008478369-2020-00001 (INTERNAL FERROSAN MEDICAL DEVICES A/S REPORT NO.: (B)(4)) FOR EVALUATION OF THIS EVENT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 9784624 ↗
• InjuryMar 4, 2020Insufficient Heating

  THIS REPORT COVERS PATIENT NO. 2 OUT OF 20. PLEASE REFER TO FDA REPORT NO: 3008478369-2020-00001 (INTERNAL FERROSAN MEDICAL DEVICES A/S REPORT NO: QN (B)(4)) FOR EVALUATION OF THIS EVENT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 9784623 ↗
• InjuryMar 4, 2020Insufficient Heating

  THIS REPORT COVERS PATIENT NO. 11 OUT OF 20. PLEASE REFER TO FDA REPORT NO.: 3008478369-2020-00001 (INTERNAL FERROSAN MEDICAL DEVICES A/S REPORT NO.: (B)(4)) FOR EVALUATION OF THIS EVENT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 9784617 ↗
• InjuryMar 2, 2020Insufficient Heating

  THIS REPORT COVERS PATIENT NO. 10 OUT OF 20 PLEASE REFER TO FDA REPORT NO.: 3008478369-2020-00002 (INTERNAL FERROSAN MEDICAL DEVICES A/S REPORT NO.: (B)(4) FOR EVALUATION OF THIS EVENT.

  Patient problems: No Information

  MAUDE report 9773884 ↗
• InjuryFeb 5, 2020Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED TO THE DISTRIBUTOR FROM A CUSTOMER THAT DURING AN UNKNOWN PROCEDURE "PRODUCT IS NOT MELTING CAUSING PAIN AND INFECTION IN PATIENT". THE SURGICAL PROCEDURE IS UNKNOWN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 9670620 ↗
• InjuryFeb 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND AN ABSORBABLE HEMOSTAT WAS USED. POST-OPERATIVELY, THE PRODUCT IS NOT MELTING CAUSING PAIN AND INFECTION IN THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pain; Swelling; Unspecified Infection

  MAUDE report 9664484 ↗
• InjuryMay 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT TYMPANOPLASTY WITHOUT OSSICULAR RECONSTRUCTION AND RIGHT MYRINGOPLASTY ON (B)(6) 2018 AND AN ABSORBABLE HEMOSTAT WAS USED ON BOTH EARS. THE DEVICE WAS USED AS DISSOLVABLE PACKING IN THE MIDDLE EAR AND THE EXTERNAL CANAL. IT DID NOT DISSOLVE. THE PATIENT WAS A CHILD, AND IT WAS VERY DIFFICULT TO GET IT OUT OF THE EAR, DESPITE MONTHS OF EAR DROPS. THE PATIENT RETURNED TO THE OR. THE SURGEON REMOVED INTACT PIECES OF THE ABSORBABLE HEMOSTAT FROM BOTH MIDDLE EARS, THE MYRINGOPLASTY ON THE RIGHT FAILED AND THE TYMPANOPLASTY ON THE LEFT FAILED. ADDITIONAL INFORMATION HAD BEEN REQUESTED AND WAS RECEIVED.

  Patient problems: Not Applicable

  MAUDE report 8592467 ↗
• InjuryApr 23, 2019Inadequate Instructions for Healthcare Professional; Improper or Incorrect Procedure or Method

  DESCRIPTION: AS PART OF PREPARATION FOR THE POST-MARKET SURVEILLANCE REPORT, AUTHORITY ADVERSE EVENT SEARCH FOR Q1 2019, A MAUDE (FDA) SEARCH WAS PERFORMED ON THE 6 APRIL 2019. THE SEARCH IDENTIFIED ONE EVENT FOR SURGIFOAM® WHICH HAS NOT BEEN REPORTED TO FERROSAN MEDICAL DEVICES (B)(4). THEREFORE, A QUALITY NOTIFICATION WAS RAISED TO CAPTURE THIS EVENT. FERROSAN MEDICAL DEVICES (B)(4), REFERENCE NUMBER: (B)(4). THE FDA REPORTING NUMBERS ARE: MDR REPORT KEY: (B)(4) AND REPORT NUMBER: MW5085220. ACCORDING TO THE FDA REPORTING, THE EVENT WAS REPORTED TO FDA ON THE 24 MARCH 2019, THE EVENT TOOK PLACE ON (B)(6) 2019. THE USED PRODUCT WAS SURGIFOAM. NO FURTHER INFORMATION IS AVAILABLE AS TO PRODUCT SIZE, PRODUCT CODE OR LOT NUMBER. EVENT DESCRIPTION FROM THE REPORT: "PATIENT HAD ANAPHYLAXIS IN OPERATING ROOM DURING NEUROSURGICAL PROCEDURE SHORTLY AFTER PLACEMENT OF SURGIFOAM IN EPIDURAL SPACE. REQUIRED EPINEPHRINE, STEROIDS, ALBUTEROL, ANTIHISTAMINES. INCISION RE-OPENED BY SURGEON AND PRODUCT REMOVED. PATIENT FULLY RECOVERED. PATIENT WITH KNOWN PORCINE AND BOVINE GELATIN ALLERGY. ALTHOUGH PACKAGING SAYS "GELATIN" THERE ARE NO WARNINGS ON PACKAGING ABOUT GELATIN ALLERGIC PATIENTS AND NO R

  Patient problems: Anaphylactic Shock

  MAUDE report 8539431 ↗

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