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First Aid Only

Acme United Corporation · Model FAE-6015 · UDI-DI 00092265060158

OHO
0
510(k) clearances
5
Adverse events
1
Recalls
235
Facilities

Description

Smart Compliance box First aid CPR mask and 1 pair of gloves

Recalls

DateFirmReason
2026-07-07INTEGRATED MEDCRAFT LLCDevices could potentially contain an occluded or partially occluded Guedel Airway tip.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data 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.