3M™ 56945Recalls & reported problems
3M Deutschland GmbH · 3M™ Astringent Retraction Paste, Value Pack, 56945 · 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 04054596646407), received between Mar 14, 2025 and Mar 14, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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
- Patient Device Interaction Problem1
Patient problems
- Erosion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 14, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
THE PATIENT ALLEGEDLY EXPERIENCED A BURN-LIKE REACTION SHORTLY AFTER 3M ASTRINGENT RETRACTION PASTE WAS APPLIED AROUND TOOTH 34. THE DENTAL PROFESSIONAL CLEANED THE AREA, PERFORMED RINSES AND PRESCRIBED CORSODYL FOR A FEW DAYS BUT THE AFFECTED AREA STILL APPEARED NECROTIC. WHEN THE PATIENT RETURNED FOR A FOLLOW-UP VISIT ON (B)(6) 2025, A HYDROGEN PEROXIDE RINSE WAS PERFORMED AND ORACORT AND DALACIN WERE PRESCRIBED. THE CONDITION SIGNIFICANTLY IMPROVED, BUT A LESION REMAINS ON THE ROOT NEAR THE TOOTH'S NECK.
Patient problems: Erosion
MAUDE report 21612925 ↗
Other Cord, Retraction devices
- Advance Dental Products 504600-28The Atlanta Dental Supply Company · CORD, RETRACTION1 recall0 reports
- Hemodent 9007071Premier Dental Products Company · Cord, Retraction1 report
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.
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