SURGIFOAM® Absorbable Gelatin Powder Kit 1979Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15712123000264), received between Apr 16, 2024 and Apr 16, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

4 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.

Recalls naming this device

1. Apr 23, 2024Class IIOpen, Classified

   Some applicator tips from these lots had open seals.

   Z-1881-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionApr 16, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  CUSTOMER NOTIFIED REP OF ISSUES YET AGAIN WITH 1979. APPEARED TO BE DIFFERENT LOT #S THAN PREVIOUS COMPLAINTS. REP TO PICK UP PRODUCT AND VERIFY. THE ISSUE BEING THAT THE PACKAGE THAT THE SYRINGE TIP COMES IN IS NOT SEALED ENTIRELY FOR STERILIZATION. THE CUSTOMER LUCKILY WENT THROUGH THEIR ENTIRE INVENTORY AS WAS ABLE TO IDENTIFY ABOUT 10 EACHES THAT THIS AFFECTED. NO PATIENT HARM. TEN PRODUCTS ARE AVAILABLE FOR EVALUATION. THE CASES ARE CONSIDERED NEAR ADVERSE EVENTS (IF THE EVENT OCCURRED AGAIN, IT COULD RESULT IN A SERIOUS ADVERSE EVENT). 2 CASES WITH A TOTAL OF 14 COMPLAINTS WERE RECEIVED FROM ETHICON'S COMPLAINT TEAM ON (B)(6) 2024 AND (B)(6) 2024 RESPECTIVELY. THE CASES ARE CONSIDERED NEAR ADVERSE EVENTS PER 03.04.2024. INITIALLY, THE CASES WERE NOT EVALUATED TO BE NEAR ADVERSE EVENTS AS THE MALFUNCTION WAS DISCOVERED PRIOR TO SURGERY. NO DELAY IN SURGERY AND NO PATIENT HARM WAS REPORTED. AS THE SECOND COMPLAINT WAS RECEIVED, AND NO COMPLAINT SAMPLES WERE RECEIVED FROM THE FIRST COMPLAINT, THE RETAINED SAMPLES FOR THE BATCH/ES WERE INVESTIGATED. THE INVESTIGATION REVEALED THAT THERE WAS A RISK FOR THE SURGEON/NURSE TO OVERLOOK THE COMPRISED STERILE BARRIER AND USE A POSSIBLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19114333 ↗
• MalfunctionApr 16, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS NOTED PER THE OR DIRECTOR THAT THERE WERE FOUR UNITS OF PRODUCT # 1979 THAT HAD UNSTERILE COMPONENTS (THE PACKAGING OF THE APPLICATOR TIP IN FOUR OF THE UNITS WAS NOT COMPLETELY SEALED) NO PATIENT HARM WAS REPORTED. DEVICE WILL BE RETURNED. FOUR PRODUCTS ARE AVAILABLE FOR EVALUATION. THE CASES ARE CONSIDERED NEAR ADVERSE EVENTS (IF THE EVENT OCCURRED AGAIN, IT COULD RESULT IN A SERIOUS ADVERSE EVENT). THE STERILE BARRIER WAS COMPROMISED. 2 CASES WITH A TOTAL OF (B)(4) COMPLAINTS WERE RECEIVED FROM ETHICON'S COMPLAINT TEAM ON (B)(6) 2024 AND (B)(6) 2024 RESPECTIVELY. THE CASES ARE CONSIDERED NEAR ADVERSE EVENTS PER 03.04.2024. INITIALLY, THE CASES WERE NOT EVALUATED TO BE NEAR ADVERSE EVENTS AS THE MALFUNCTION WAS DISCOVERED PRIOR TO SURGERY. NO DELAY IN SURGERY AND NO PATIENT HARM WAS REPORTED. AS THE SECOND COMPLAINT WAS RECEIVED, AND NO COMPLAINT SAMPLES WERE RECEIVED FROM THE FIRST COMPLAINT, THE RETAINED SAMPLES FOR THE BATCH/ES WERE INVESTIGATED. THE INVESTIGATION REVEALED THAT THERE WAS A RISK FOR THE SURGEON/NURSE TO OVERLOOK THE COMPRISED STERILE BARRIER AND USE A POSSIBLE NON-STERILE PRODUCT IN A PATIENT. THE AWARENESS DATE IS CONSIDERED AS (B)(6) 2024 AS THIS WAS T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19114109 ↗

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-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