Class II — TURBETT SURGICAL, LLC
| Recalling firm | Turbett Surgical, Inc |
|---|---|
| Registered facility | TURBETT SURGICAL, Inc (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use. |
| Product | Turbett Surgical Container, TS1500 |
| Quantity | 232 units |
| Distribution | Domestic distribution to PA, CA, and NY only. |
| Initiated | 2022-04-01 |
| Classified | 2022-05-18 |
| Recall number | Z-1111-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — TURBETT SURGICAL, LLC (Z-1111-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90132/
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