Louisville, CO, United States
Bolder Surgical, LLC recalls
1 recall recorded since 2018, most recently on 25 January 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 25 January 2022
- Terminated
- 15 May 2024
- 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.
- Distribution
- US: NY, MO, DE, PA, FL OUS: Italy, Chile, UK
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0736-2022
- CoolSeal Generator, REF: CSL-200-50
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.