Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number:… — Class II medical device recall Z-0261-2022
Ongoing recall by CooperSurgical, Inc., reported 2021-11-24, distributed nationwide. Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue
| Recall number | Z-0261-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperSurgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2021-09-29 |
| Classified | 2021-11-18 |
| Reported by FDA | 2021-11-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BO, CA, CL, CN, CR, DE, DO, EC, GB, HK, ID, IN, IR, IT, JO, KE, LK, MX, MY, NG, NI, NZ, PH, QA, SG, TH, TR, TT, TW, VN, ZA |
| Quantity | 193 units |
| Serial numbers | 0112010, 0114011, 0209001, 0212004, 0214002, 0214007, 0309031, 0312021, 0313007BFIX, 0313010B, 0411002, 0413003B, 0609010FIX, 0612001B, 0710001, 0710003, 0711008, 0711008FIX, 0713011C, 0713018C, 0809009, 0811017, 0813032CFIX, 0813033C, 091402 and 34 more |
| Model numbers | 909075 |
Product
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075
Reason for recall
Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.
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-0261-2022. 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.