Agiliti Health - Hays
1 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (1)
Devices registered here (1)
- Wheelchair, MechanicalProduct code IOR (opens in a new tab) · Class I · Physical Medicine · 21 CFR 890.3850
Recalls & enforcement
- Class IIOngoing2024-01-25Retrospective engineering analysis against current ISO standards for hoists has determined: 1. The device cannot physically perform at maximum documented weight specifications when a factor of safety of two times the maximum load is applied. 2. The device is not equipped with a…
Related
- All facilities operated by RAYE'S, Inc dba Sizewise Manufacturing a wholly owned subsid
- Agiliti Health - Ellis (KS)
- Agiliti Health - Corona (CA)
- Agiliti Health - Milwaukee (WI)
- RASMUSSEN DE TECATE S.A. DE C.V. (MX)
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Agiliti Health - Hays (FEI 1931307) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1931307-agiliti-health-hays/
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