CoolSeal Generator manufacturing defect may cause unintended energy delivery to patients
CoolSeal Generator units (REF: CSL-200-50) may have a manufacturing defect preventing them from meeting electrical safety standards, potentially resulting in unintended energy delivery to patients.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a medical device with potential for patient harm (unintended energy delivery) where no illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported are rated as High (3).
Plain-English summary
Bolder Surgical, LLC is recalling the CoolSeal Generator (REF: CSL-200-50) due to a potential manufacturing or assembly defect. The affected units may not meet IEC 60601 standards for medical electrical equipment, which could result in the delivery of unintended energy to patients under certain conditions.
The recall affects 10 units with serial numbers 00161-170. Distribution includes multiple U.S. states—New York, Missouri, Delaware, Pennsylvania, and Florida—as well as international locations in Italy, Chile, and the United Kingdom.
Healthcare facilities and providers using the CoolSeal Generator with the identified serial numbers should immediately remove the devices from clinical use. Contact Bolder Surgical, LLC for instructions on replacement or return procedures.
The recalled product
- Product
- CoolSeal Generator, REF: CSL-200-50
- Manufacturer
- Bolder Surgical, LLC
- Hazard
- electrical-hazard
- manufacturing-defect
- compliance-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Serial Numbers: 00161-170
- UDI: 00850346007023
Distribution
Distributed in 5 states:
- DE
- FL
- MO
- NY
- PA
Related recalls
Same category
- ModerateZeiss Intrabeam Spherical Applicator failed manufacturing specifications
FDA (Devices) · 2026-07-08
- SevereOmnipod 5 Insulin Infusion Pods Recalled for External Cannula Damage
FDA (Devices) · 2026-07-08
- HighBoston Scientific CRE Pro Wireguided 12-15mm Esophageal Stent Recall
FDA (Devices) · 2026-07-08
- HighMedline Convenience Kits with Recalled Swan-Ganz Catheters Nationwide
FDA (Devices) · 2026-07-08
- HighMedline Convenience Kits with Recalled Swan-Ganz Catheters
FDA (Devices) · 2026-07-08