Bovie Velocity Disposable Bipolar Ablators Recalled for Sterile Packaging Defect
Bovie Medical Corporation is recalling Velocity Disposable Bipolar Ablators because pinholes in the sterile packaging may compromise the sterile barrier.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential sterile barrier breach without reported injuries or illnesses, fitting the criteria for a moderate severity rating.
Plain-English summary
Bovie Medical Corporation is recalling 5,894 units of Velocity Disposable Bipolar Ablators. These medical devices are intended for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures. The recall involves specific catalog numbers and lots, including 7201, 7205, 7206, 7201-01, and 7203.
The recall was initiated due to a potential breach of the sterile packaging barrier. This issue is caused by the development of pinholes at the crease of the double-folded edge of the current package configuration. The affected units were distributed nationwide in the states of California and Florida.
Healthcare facilities and consumers should stop using the affected devices and contact Bovie Medical Corporation for instructions on return or replacement. The U.S. Food and Drug Administration has classified this as a Class II recall.
The recalled product
- Product
- Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.
- Manufacturer
- Bovie Medical Corporation
- Hazard
- Affected units
- 5,894
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 (20)
- 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
Distribution
Part of a larger recall action
This product is one of 3 recalled by Bovie Medical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Bovie Medical Corporation
See all →- ModerateBovie Medical Recalls HNM Disposable Bipolar Ablators Due to Packaging Defect
FDA (Devices) · 2021-03-10
- ModerateBovie Medical Recalls ConMed Disposable Bipolar Ablators Due to Packaging Defect
FDA (Devices) · 2021-03-10
- HighBovie Medical Recalls Renuvion J-Plasma Precise Handpieces Due to Fracture Risk
FDA (Devices) · 2020-05-27
- SevereBovie Medical Recalls Renuvion J-Plasma Precise Open Handpieces Due to Fracture Risk
FDA (Devices) · 2020-05-27
- SevereBovie J-Plasma Precise 360 Handpiece Recalled for Tip Separation Risk
FDA (Devices) · 2018-10-31
Same hazard · sterile barrier breach
See all →- ModerateBoston Scientific Radial Jaw 4 Biopsy Forceps Recalled Due to Sterile Barrier Breach Risk
FDA (Devices) · 2026-08-12
- SevereRadial Jaw 4 Jumbo Biopsy Forceps Packaging Sterile Barrier Recall
FDA (Devices) · 2026-08-12
- HighBiopsy Forceps Recall: Sterile Packaging Breach Risk
FDA (Devices) · 2026-08-12
- ModeratePhantom Hindfoot Guide Rods Recalled Due to Sterile Barrier Breaches
FDA (Devices) · 2026-07-29
- HighMedtronic DLP Retrograde Cannula 15FR Model 94665 Sterile Barrier
FDA (Devices) · 2026-05-27