GRACE MEDICAL, INC.
1 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (1)
- Inspections (1)
Devices registered here (1)
- Drape, Surgical, ExemptProduct code PUI (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4370
Recalls & enforcement
- Class IIOngoing2026-04-03Due to incorrect functional length on device labeling.
FDA inspections (1)
- VAI2016-05-27Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
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
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. “GRACE MEDICAL, INC. (FEI 1000022662) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000022662-grace-medical-inc/
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