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Dr. Scholl's
BAYER HEALTHCARE LLC · Model 1612171 · UDI-DI 00311017405307
1
510(k) clearances
3,228
Adverse events (57 deaths)
106
Recalls
109
Facilities
Description
Dr. Scholl's Dual Action Freeze Away Wart Remover provides convenient home use treatment for noncancerous, yet contagious plantar and common warts. It is a combination of freezing and liquid ( acid) treatment of the wart. It consists of the following: pressurized canister filled with liquid mixture of dimethyl ether and propane, reusable activator that releases the cryogen into the applicator, 7 disposable applicators, 9.8ml liquid wart remover, 9 cover- up cushions, and information booklet.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-26 | Erbe USA Inc | A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in CO2 leaking into the |
| 2026-02-12 | Erbe USA Inc | Probes may rupture/burst during activation |
| 2026-02-12 | Erbe USA Inc | Probes may rupture/burst during activation |
| 2026-02-12 | Erbe USA Inc | Probes may rupture/burst during activation |
| 2025-08-18 | Boston Scientific Corporation | Certain desiccant tube subassemblies were built with end caps that were not correctly tightened. |
| 2025-08-18 | Boston Scientific Corporation | Certain desiccant tube subassemblies were built with end caps that were not correctly tightened. |
| 2025-03-24 | Boston Scientific Corporation | Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings |
| 2025-03-24 | Boston Scientific Corporation | Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings |
| 2025-03-24 | Boston Scientific Corporation | Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings |
| 2025-03-24 | Boston Scientific Corporation | Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.