LEEP procedure packs recalled over smoke pencils that may self activate
Medline is recalling 18 GP-LEEP convenience packs containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Scored 3 under the risk-of-harm criterion: an electrosurgical pencil that can activate without input or stay active is a burn hazard, and no injuries are reported.
Plain-English summary
Medline convenience kits labelled GP-LEEP PACK-LF, REF PHS396969004F, containing SafeAir Smoke Evacuation Pencils, are being recalled.
Stryker Instruments has expanded the scope of its recall of SafeAir Smoke Evacuation Pencils, first initiated in October 2024, adding an additional 47 lots. The initial recall was due to the potential for the product to activate without manual input when plugged into a power source, or to remain active after the buttons are released.
The recall covers 18 units from lot 23HDA742, carrying UDI/DI 10195327454227 for each unit and 40195327454228 for the case. The product was distributed nationwide in the United States. The FDA has classified the action as Class II.
An electrosurgical pencil that activates on its own or stays live is a burn hazard in the operating field. The enforcement record reports no injuries. Facilities should quarantine the affected lot and follow Medline's instructions.
The recalled product
- Product
- MEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004F
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical kit
- Affected units
- 18
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)
- UDI/DI 10195327454227 (each) 40195327454228 (case)
- Lot Numbers: 23HDA742
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 recalled by Medline Industries, LP 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 20 products in this recall →Related recalls
Same manufacturer · Medline Industries, LP
See all →- ModerateMedline Foot Ankle Convenience Kit Recalled for Shelf-Life Discrepancy
FDA (Devices) · 2026-10-21
- ModerateMedline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
- ModerateMedline surgical convenience kits recalled for non-conforming cannula components
FDA (Devices) · 2026-10-21
- SevereMedline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
- ModerateMedline recalls CONMED AirSeal Access Port kits due to pressure alerts
FDA (Devices) · 2026-10-21
Same hazard · unintended activation
See all →- HighDa Vinci 5 tower may unintentionally activate the infrared handheld camera
FDA (Devices) · 2026-06-10
- Severe
- HighSpectrometer modules recalled over elevated laser output and unintended firing
FDA (Drugs) · 2026-01-21
- HighPacemaker packs recalled over smoke pencils that can remain active
FDA (Devices) · 2025-11-26
- HighPort insertion packs recalled over smoke pencils that may stay live
FDA (Devices) · 2025-11-26
Similar recalls
- HighMedline recalls surgical kits containing Stryker smoke evacuation pencil component
FDA (Devices) · 2024-12-11
- ModerateMedline Recalls Medical Devices Manufactured Using Stryker-Recalled Smoke Evacuation Components
FDA (Devices) · 2024-12-11
- HighMedline recalls surgical convenience kits with defective smoke evacuation component
FDA (Devices) · 2024-12-11
- ModerateMedline Convenience Kits Recalled Due to Defective Smoke Evacuation Component
FDA (Devices) · 2024-12-11
- ModerateMedline Surgical Kits Recalled for SafeAir Smoke Evacuation Pencils
FDA (Devices) · 2024-12-11
- ModerateMedline Surgical Convenience Kits Recalled Over Supplier Component Recall
FDA (Devices) · 2024-12-11