GENTELL
2 recall(s) on record — most severe on record: Class II.
Recalls by year
- Recalls (2)
Registered facilities (4)
- GENTELL FEI 1000522686 · PA
- DERMA SCIENCES NANTONG INCORPORATION FEI 3003636207 · CN
- DERMA SCIENCES CANADA, INC (dba DERMA SCIENCES, INC.) FEI 3002806830 · CA
- FIRST WATER RAMSBURY LTD FEI 3002265219 · GB
Recalls & enforcement
- Class IIOngoing2020-03-26During an FDA audit, it was discovered that the product was not properly registered with FDA.
- Class IIOngoing2020-02-27During an FDA audit, it was discovered that the product was not properly registered with FDA.
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “GENTELL — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10026501-gentell/
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