CoolSeal Generator — Class II medical device recall Z-0736-2022
Terminated recall by Bolder Surgical, LLC, reported 2022-03-16, distributed in DE, FL, MO, NY, PA. A potential manufacturing/assembly defect could result in the generator not meeting IEC 60601 standards for me
| Recall number | Z-0736-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bolder Surgical, LLC, Louisville, CO, United States |
| Recall initiated | 2022-01-25 |
| Classified | 2022-03-08 |
| Reported by FDA | 2022-03-16 |
| Terminated | 2024-05-15 |
| Distributed | DE, FL, MO, NY, PA |
| Countries outside the US | CL, GB, IT |
| Quantity | 10 |
| UPC / GTIN / UDI-DI | 00850346007023 |
| Serial numbers | 00161-170 |
| Model numbers | CSL-200-50 |
Product
CoolSeal Generator, REF: CSL-200-50
Reason for recall
A potential manufacturing/assembly defect could result in the generator not meeting IEC 60601 standards for medical electrical equipment, and it can potentially, under specific conditions, lead to the delivery of unintended energy to the patient.
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-0736-2022. 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.