RegWardenFDA facility compliance records
Facility

CAREFREE SURGICAL SPECIALTIES, INC.

1 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2025: 1 recalls20172018201920202021202220232024120252026
  • Recalls (1)

Devices registered here (1)

  • Gauze/Sponge, Internal, X-Ray Detectable
    Product code GDY (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4450

Recalls & enforcement

  • Class IIOngoing2025-07-01
    Due 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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