GI4000 Electrosurgical Unit — Class II medical device recall Z-0241-2023
Terminated recall by Steris Corporation, reported 2022-11-23, distributed nationwide. Two electronic diode components (D1 & D4) placed in the reverse orientation on the controller printed circuit
| Recall number | Z-0241-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Steris Corporation, Mentor, OH, United States |
| Recall initiated | 2022-10-17 |
| Classified | 2022-11-16 |
| Reported by FDA | 2022-11-23 |
| Terminated | 2024-05-28 |
| Distributed | Nationwide (US) |
| Quantity | 5 units |
| UPC / GTIN / UDI-DI | 00724995180256 |
| Serial numbers | 0032-0082-002, 0032-0622-009, 0032-0822-001, 0032-0822-003, 0032-0922-001 |
| Model numbers | G1110001 |
Product
GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or without delivery of argon gas, in flexible endoscopic applications. MODEL #(s): G1110001
Reason for recall
Two electronic diode components (D1 & D4) placed in the reverse orientation on the controller printed circuit board assembly may result in premature wear of the power regulator, leading to the regulators failure which could cause a full power loss. If the regulator failure were to occur during a patient procedure, a procedural delay may result
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0241-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.