FDA Device recall Z-0736-2022
CoolSeal Generator, REF: CSL-200-50
- FDA Device
- Class II
- terminated
- Published 2022-03-16
On 2022-03-16 the FDA classified a Class II recall of CoolSeal Generator, REF: CSL-200-50 by Bolder Surgical, citing 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 co….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0736-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-01-25 |
| Published | 2022-03-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Bolder Surgical |
| Distribution | DE, FL, MO, NY, PA |
Product
CoolSeal Generator, REF: CSL-200-50
Reason
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.
Identifiers
| code_info | Serial Numbers: 00161-170, UDI: 00850346007023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0736-2022%22
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