Medline Surgical Kits Recalled Due to Defective Smoke Evacuation Component
Medline is recalling 167,074 surgical convenience kits nationwide containing SafeAir Smoke Evacuation Pencils previously recalled by manufacturer Stryker for use in various surgical procedures.
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: FDA Class II classification for a surgical device with a recalled component. The recall classification and component-level issue indicate potential risk to surgical patients.
Plain-English summary
Medline Industries, LP is recalling 167,074 surgical convenience kits nationwide because they contain SafeAir Smoke Evacuation Pencils that were previously recalled by their manufacturer, Stryker. The affected kits are designated for use in various surgical procedures, including abdominal laparoscopy, laparotomy, and general surgery operations.
The affected kits were distributed nationwide to hospitals and surgical facilities. Healthcare providers using these products should discontinue use immediately and contact Medline Industries for guidance on replacement or return of the affected kits. The FDA has assigned recall number Z-0630-2025 to this recall.
The recalled product
- Product
- MEDLINE convenience kits labeled as: 2) ABDOMINAL LAPAROSCOPY, REF CDS760057K; 3) ABDOMINAL LAPAROSCOPY, REF CDS760057L; 4) MAJOR LAPAROTOMY CDS, REF CDS860015W; 5) MINOR LAPAROTOMY CDS, REF CDS860016P; 6) MINOR LAPAROTOMY CDS, REF CDS860016Q; 7) MINOR LAPAROTOMY CDS, REF…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 167,074
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)
- 1) REF CDS760057J
- UDI/DI 10195327008963 (each) 40195327008964 (case)
- Lot Numbers: 22FBX954
- 22FBE976
- 2) REF CDS760057K
- UDI/DI 10195327274368 (each) 40195327274369 (case)
- Lot Numbers: 23ABU244
- 22LBC409
- 23GBN928
- 23CBO552
- 23EBA183
- 23JBH987
- 3) REF CDS760057L
- UDI/DI 10195327533373 (each) 40195327533374 (case)
- Lot Numbers: 23KBL294
- 4) REF CDS860015W
- UDI/DI 10195327349509 (each) 40195327349500 (case)
- Lot Numbers: 23FBP597
- 5) REF CDS860016P
- UDI/DI 10193489848007 (each) 40193489848008 (case)
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 28 recalled by MEDLINE INDUSTRIES, LP - Northfield 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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