Recall archive / FDA device enforcement
CoolSeal Generator, REF: CSL-200-50 — FDA record Z-0736-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 25, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Bolder Surgical, LLC
- Quantity
- 10
- Agency-reported status
- Terminated
- Source record identifier
- Z-0736-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Serial Numbers: 00161-170, UDI: 00850346007023 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: NY, MO, DE, PA, FL OUS: Italy, Chile, UK
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Mar 16, 2022
- Recall initiation date
- Jan 25, 2022
- Center classification date
- Mar 8, 2022
- Termination date
- May 15, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.