Local basic kits recalled over smoke pencils that may stay active
Medline is recalling 48 LOCAL BASIC convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
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: 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 LOCAL BASIC, REF DYNJ34418M, 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 48 kits from lots 24CBO120 and 24DBA216, carrying UDI/DI 10195327384371 for each unit and 40195327384372 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 affected lots and follow Medline's instructions.
The recalled product
- Product
- MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical kit
- Hazard
- unintended-activation
- electrosurgical
- burn-risk
- recall-expansion
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 (4)
- UDI/DI 10195327384371 (each)
- 40195327384372 (case)
- Lot Numbers: 24CBO120
- 24DBA216
Distribution
Distributed nationwide across the United States.
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