Agent, Absorbable Hemostatic, Collagen Based
FDA adverse event reports and recall history for agent, absorbable hemostatic, collagen based (product code LMF), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 2,102
- Deaths
- 92
- Injuries
- 1,671
- Malfunctions
- 309
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-04-21Open, ClassifiedUnder Investigation by firm
Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
Potential for product to contain foreign matter, confirmed to be inspect fragments.
- 2024-05-22Open, ClassifiedUnder Investigation by firm
SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
Some applicator tips from these lots had open seals.
- 2024-01-05Open, ClassifiedUnder Investigation by firm
Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes: a) ADS201844, 5 mL b) ADS201845, 10mL
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
- 2024-01-05Open, ClassifiedUnder Investigation by firm
Baxter FloSeal Hemostatic Matrix RECOTHROM, Product Codes: a) ADS202105, 5mL-6 PK US b) ADS202110, 10mL US
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
- 2022-08-26Open, ClassifiedEnvironmental control
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 to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical.
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- 2013-05-10TerminatedProcess control
INSTAT - Agent, Absorbable Hemostatic, Collagen Based INSTAT MCH is recommended for use in surgical procedures (other than Urological and Ophthalmological surgery) as an adjunct to hemostatis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
- 2013-05-10TerminatedProcess control
Helistat Absorbable Hemostatic,Collagen Based Helistat is indicated in surgical procedures (other than ophthalmological and urological surgery) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
- 2013-05-10TerminatedProcess control
Helitene Absorbable Collagen Hemostatic Sponge Helitene is indicated in surgical procedures (other than ophthalmological and urological surgery) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
- 2013-05-10TerminatedProcess control
Absorbable Collagen Sponge Provided As Intermediate to Another Company
Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
- 2012-11-22TerminatedDevice Design
Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat. Sterile, single use device designed to prepare plasma from the patient's blood using a tabletop centrifuge.
When preparing plasma using VitaPrep, it was reported that a small amount of blood collected in the bottom of the centrifuge cup following the centrifugation step. Firm has since discovered that if blood is present in the Luer connection of the VitaPrep following the blood draw step, this blood could be displaced to the outside of the syringe when the VitaPrep cap is reattached to the syringe. T
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