SURGICAL INNOVATIONS PLC
3 recall(s) on record — most severe on record: Class II.
Recalls by year
- Recalls (3)
Registered facilities (1)
- SURGICAL INNOVATIONS LTD FEI 3002808173 · GB
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.
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “SURGICAL INNOVATIONS PLC — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9008575-surgical-innovations-plc/
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