SURGICAL INNOVATIONS LTD
3 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (3)
Devices registered here (1)
- Laparoscope, General & Plastic SurgeryProduct code GCJ (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.1500
Recalls & enforcement
- Class IIOngoing2023-03-28Optical Trocars sterility assurance can not be guaranteed
- Class IICompleted2022-06-02There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product.
- Class IIOngoing2022-01-20Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.
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. “SURGICAL INNOVATIONS LTD (FEI 3002808173) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002808173-surgical-innovations-ltd/
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