CAREFREE SURGICAL SPECIALTIES, INC.
1 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (1)
Devices registered here (1)
- Gauze/Sponge, Internal, X-Ray DetectableProduct code GDY (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4450
Recalls & enforcement
- Class IIOngoing2025-07-01Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging
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. “CAREFREE SURGICAL SPECIALTIES, INC. (FEI 1000221450) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000221450-carefree-surgical-specialties-inc/
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