FLOSEAL HEMOSTATIC MATRIX ADS201844Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00085412639598), received between Sep 17, 2026 and Sep 17, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (1 report).

3 other recalls cover devices cleared under the same FDA submission (P990009); 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.

• MalfunctionSep 17, 2026Device Damaged Prior to Receipt by User

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50810467 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P990009. One submission often covers many models, so check the product and lot details in each record.

• Z-0667-2024 · Dec 6, 2023 · Open, Classified
  Baxter FloSeal Hemostatic Matrix NL, 5 mL, Product Codes: ADS201883
• Z-2957-2018 · May 30, 2018 · Open, Classified
  FLOSEAL Special Applicator Tips in cartons labeled in part, "Floseal SPECIAL APPLICATOR TIPS***6 x Malleable Tip Trimmable Tip***Baxter***." The pouches inside the cartons are lab
• Z-2340-2008 · Jul 31, 2008 · Terminated
  FloSeal Endoscopic Applicator , Product Code 1500181. The product is indicated in surgical procedures (other than in neurosurgical, opthalmic, and urological) as an adjunct to hem