FDA Medical Device Recalls (openFDA)
Bolder Surgical, LLC: CoolSeal Generator, REF: CSL-200-50
- Recall number
- Z-0736-2022
- Recalling firm
- Bolder Surgical, LLC
- Product
- CoolSeal Generator, REF: CSL-200-50
- Status
- Terminated
- Initiated
- 2022-01-25
- Posted
- not on file
- Terminated
- 2024-05-15
- 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.
- Root cause
- Process control
- Action
- On 01/25/22, recall notices were hand delivered to U.S. customers and emailed to O.U.S. customers. Customers were asked to do the following: Discontinue use and return affected devices to the recalling firm, and complete and return the acknowledgment form. Customers with additional questions were encouraged to contact the recalling firm at 1-866-683-1743.
- Quantity
- 10
- Distribution
- US: NY, MO, DE, PA, FL OUS: Italy, Chile, UK
- Lot, serial or model codes
- Serial Numbers: 00161-170, UDI: 00850346007023
- 510(k) numbers
- ["K202114"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 3010377594
- Firm city
- Louisville
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28