SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. Hemorrhoidectomy Sponge 1977Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15712123000226), received between Nov 25, 2025 and Nov 25, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Off-Label Use” (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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2025Off-Label Use; Off-Label Use

  MY HUSBAND HAD SURGERY AT XX ON (B)(6) 2025 ON THE SURGERY DATE THE SURGEON USED YOUR PRODUCT THAT HE HAD USED IN A PREVIOUS SURGERY ON MY HUSBAND. SURGERY SITE WAS NOT HEALING PROPERLY. THERE WAS NO REASON FOR THIS WE COULD DISCERN EVERYTHING WAS CLEAN. IT WAS NOT INFECTED BUT THE WOUND WAS NOT CLOSING. ABOUT (B)(6) 2025 HIS HAND BEGAN TO SWELL AND BECOME EXTREMELY PINK AND THEN STUFF STARTED TO COME OUT LIKE JELLY FIRST IT WAS JUST A COUPLE PIECES THEN IT WAS A LOT. THIS WENT ON FOR ABOUT TWO WEEKS OF EXTREME PAIN AND LEAKAGE FROM THE WOUND AND THIS JELLY-LIKE SUBSTANCE COMING OUT AFTER SPEAKING TO THE SURGEON, HE BELIEVES IT IS YOUR PRODUCT THAT DID NOT DISSOLVE. WE BELIEVE THIS WAS POSSIBLY A BAD BATCH. MY HUSBAND HAD THE SAME THING ON THE OTHER HAND WITH NO PROBLEMS NOW MY HUSBAND HAS TO GO IN FOR A SECOND SURGERY TO CLEAN OUT YOUR PRODUCT. THIS IS CAUSING MORE TIME OFF OF WORK TIME OFF FOR ME TO TAKE CARE OF HIM AND EXTREME PAIN AND SUFFERING. BY NOW, MY HUSBAND WOULD HAVE BEEN WELL ON HIS WAY TO COMPLETE HEALING. THIS IS DELAYED AND COMPLETELY STARTED OVER THE HEALING PROCESS NOW THAT HE HAS TO HAVE ANOTHER SURGERY TO CLEAN THIS OUT. NOT TO MENTION GOING IN FOR ANOTHER PROCE

  Patient problems: Abscess; Impaired Healing; Pain; Skin Discoloration; Swelling/ Edema; Wound Dehiscence

  MAUDE report 23642325 ↗

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-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-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-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