Agiliti Health - Milwaukee
1 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (1)
- Inspections (1)
Devices registered here (1)
- Bed, Ac-Powered Adjustable HospitalProduct code FNL (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5100
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…
FDA inspections (1)
- NAI2025-04-16No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.
Related
- All facilities operated by RAYE'S, Inc dba Sizewise Manufacturing a wholly owned subsid
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- 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 - Milwaukee (FEI 3029836575) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3029836575-agiliti-health-milwaukee/
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