Covidien Sonicision Reusable Generator-converts electrical power from… — Class II medical device recall Z-2240-2021
Terminated recall by Covidien Llc, reported 2021-08-18, distributed nationwide. Potential for a manufacturing assembly error-may result in a non-functional audio indicator of device activati
| Recall number | Z-2240-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien Llc, Mansfield, MA, United States |
| Recall initiated | 2021-06-23 |
| Classified | 2021-08-10 |
| Reported by FDA | 2021-08-18 |
| Terminated | 2025-01-28 |
| Distributed | Nationwide (US) |
| Quantity | 96 units |
| UPC / GTIN / UDI-DI | 10884521592865 |
| Serial numbers | 540042X001, 540042X002, 540042X003, 540042X004, 540042X005, 540042X006, 540042X007, 540042X008, 540042X009, 540042X010, 540042X011, 540042X012, 540042X013, 540042X014, 540042X015, 540042X016, 540042X017, 540042X018, 540042X019, 540042X020, 540042X021, 540042X022, 540042X023, 540042X024, 540042X025 and 71 more |
Product
Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade. Product Number: SCGAA
Reason for recall
Potential for a manufacturing assembly error-may result in a non-functional audio indicator of device activation or a non-functional device, may cause unintended thermal burn, hemorrhage, or tissue damage and a delay of treatment while an alternate device is located
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-2240-2021. 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.