Minor eye trays recalled over smoke pencils that may stay active
Medline is recalling 345 Minor Eye Tray #81 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 MINOR EYE TRAY #81, REFs DYNJ27466S and DYNJ27466T, 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 345 kits, including UDI/DI 10195327350314 for each unit and 40195327350315 for the case, with lots 23EBC912 and 23GBA465. 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: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) MINOR EYE TRAY #81, REF DYNJ27466T.
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical kit
- Affected units
- 345
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 (9)
- 1) REF DYNJ27466S: UDI/DI 10195327350314 (each) 40195327350315 (case)
- Lot Numbers: 23EBC912
- 23GBA465
- 2) REF DYNJ27466T: UDI/DI 10195327463236 (each) 40195327463237 (case)
- Lot Numbers: 23HBF556
- 24ABL037
- 24BBI117
- 24DBJ229
- 24DBK007.
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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