Hemodent 9007071Recalls & reported problems
Premier Dental Products Company · Hemodent® liquid 10cc, Pack of 10 · 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 00348783001068), received between May 6, 2026 and May 6, 2026 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Blister1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem
BLISTERING AND SWELLING WERE OBSERVED ON THE BUCCAL GINGIVA FOLLOWING USE OF HEMODENT ON THE CERVICAL AREA. THE SYMPTOMS RESOLVED SPONTANEOUSLY WITHIN THREE DAYS.
Patient problems: Blister
MAUDE report 25094726 ↗
Other Cord, Retraction devices
- Advance Dental Products 504600-28The Atlanta Dental Supply Company · CORD, RETRACTION1 recall0 reports
- 3M™ 569453M Deutschland GmbH · 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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