Laparotomy kits recalled over smoke pencils that may activate unprompted
Medline is recalling 28,679 laparotomy 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 containing SafeAir Smoke Evacuation Pencils are being recalled, including MAJOR LAPAROTOMY CDS (REFs CDS860015W and CDS860015X), MINOR LAPAROTOMY CDS (REFs CDS860016R and CDS860016S) and LAPAROTOMY CDS #31-RF.
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 28,679 kits, including UDI/DI 10195327349509 for each unit and 40195327349500 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: 1) MAJOR LAPAROTOMY CDS, REF CDS860015W; 2) MAJOR LAPAROTOMY CDS, REF CDS860015X; 3) MINOR LAPAROTOMY CDS, REF CDS860016R; 4) MINOR LAPAROTOMY CDS, REF CDS860016S; 5) LAPAROTOMY CDS #31-RF, REF CDS860062S; 6) LAPAROSCOPY CDS, REF…
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical kit
- Affected units
- 28,679
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)
- REF CDS860015W: UDI/DI 10195327349509 (each) 40195327349500
- (case)
- Lot Numbers: CDS860015W
- REF CDS860015X: UDI/DI 10195327647513 (each) 40195327647514
- Lot Numbers: CDS860015X
- REF CDS860016R: UDI/DI 10195327349479 (each) 40195327349470
- Lot Numbers: CDS860016R
- REF CDS860016S: UDI/DI 10195327647520 (each) 40195327647521
- Lot Numbers: CDS860016S
- REF CDS860062S: UDI/DI 10195327140632 (each) 40195327140633
- Lot Numbers: CDS860062S
- REF CDS860194I: UDI/DI 10193489445152 (each) 40193489445153
- Lot Numbers: CDS860194I
- REF CDS920080T: UDI/DI 10195327349486 (each) 40195327349487
- Lot Numbers: CDS920080T
- REF CDS930027V: UDI/DI 10195327241759 (each) 40195327241750
- Lot Numbers: CDS930027V
- REF CDS930027X: UDI/DI 10195327647698 (each) 40195327647699
- Lot Numbers: CDS930027X
- REF CDS980246V: UDI/DI 10193489848342 (each) 40193489848343
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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