Pacemaker packs recalled over smoke pencils that can remain active
Medline is recalling 12 Cath Lab Pacemaker Pack convenience kits 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 CATH LAB PACEMAKER PACK, REF DYNJ59818A, 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 12 kits from lot 23KLA460, carrying UDI/DI 10195327333256 for each unit and 40195327333257 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: CATH LAB PACEMAKER PACK, REF DYNJ59818A
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical kit
- Affected units
- 12
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 (3)
- UDI/DI 10195327333256 (each)
- 40195327333257 (case)
- Lot Numbers: 23KLA460
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.
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