Z-1153-2021 Class II Ongoing
FDA device recall Z-1153-2021 was initiated by Bovie Medical Corporation on Feb 1, 2021 and is designated Class II. Reason for recall: There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration. The recall status is ongoing. Affected quantity: 5894 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 10, 2021
- Initiation Date
- Feb 1, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5894 units
Product Description
Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.
Reason for Recall
There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.
Distribution Pattern
US Nationwide distribution in the states of CA and FL.
Code Information
Catalog Numbers 7201 (lots 0217H, 0317J, 0417B, 0417F, 0417H, 0618K, 0718B, 0718D, 0718F, 0419J, 0519J, 0120F, 0420B, 0720K, 0720M, 0820L, 0117D, 0117F, 1020L); 7205 (lots 0217B, 0317L); 7206 (lots 0217B, 0317L); 7201-01 (lots 0920B, 0920D, 0920H); 7203 (0217F, 0317B, 0317L, 0417H).
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1153-2021
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026