MicroMatrix® MMFX05Recalls & reported problems
Acell, Inc. · MicroMatrix® Flex 5cc · Class U
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00386190002056), received between May 28, 2025 and May 28, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Impaired Healing1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
Other Wound dressing with animal-derived material(s) devices
- Cytal® BMM1015Acell, Inc. · DRESSING, WOUND, COLLAGEN1 recall0 reports
- PriMatrix® 607-005-812Tei Biosciences Inc. · DRESSING, WOUND, COLLAGEN1 recall0 reports
- PriMatrix® 607-005-220Tei Biosciences Inc. · DRESSING, WOUND, COLLAGEN1 recall0 reports
- Cytal® BMM0710Acell, Inc. · DRESSING, WOUND, COLLAGEN1 recall0 reports
- PriMatrix® 607-001-812Tei Biosciences Inc. · DRESSING, WOUND, COLLAGEN1 recall0 reports
- MaxxTapeCollagen Matrix, Inc. · Dressing, Wound, Collagen1 recall0 reports
- Karl Schumacher TAPE RCWT0001Karl Schumacher Dental Instrument CO., Inc. · Dressing, Wound, Collagen1 recall0 reports
- PriMatrix® 607-005-014Tei Biosciences Inc. · DRESSING, WOUND, COLLAGEN1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page