MEDLINE C-Section Kits Recalled for Defective Smoke Evacuation Component
MEDLINE is recalling 58,765 C-section convenience kits nationwide that contain SafeAir Smoke Evacuation Pencil components recalled by manufacturer Stryker. Affected kits have specific lot numbers.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II device recall with no reported illnesses, injuries, or deaths. The recall stems from a component being recalled by the manufacturer rather than directly reported hazards in the recalled kits themselves.
Plain-English summary
MEDLINE Industries, LP is recalling multiple C-section convenience kits distributed nationwide. The recall was initiated because these kits were manufactured using certain lots of SafeAir Smoke Evacuation Pencil that were subsequently recalled by Stryker, the component manufacturer.
The recall affects 58,765 units total across 174 different kit variants with distinct product reference numbers and lot codes. The kits have been distributed throughout the United States.
The C-section convenience kits are used in cesarean section procedures at hospitals and surgical centers. The affected kits contain the recalled SafeAir Smoke Evacuation Pencil component, which is present in surgical procedure kits nationwide.
The recalled product
- Product
- MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075V; 2) C-SECTION OR 30 CDS, REF CDS820075W; 3) C-SECTION, REF CDS980774M; 4) C-SECTION KIT, REF CDS981322AB; 5) C-SECTION KIT, REF CDS981322AC; 6) C-SECTION COMBINED CDS, REF CDS982398I; 7)…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 58,765
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)
- 85OHM 1) REF CDS820075V
- UDI/DI 10193489846973 (each) 40193489846974 (case)
- Lot Numbers: 22GBP851
- 2) REF CDS820075W
- UDI/DI 10195327209797 (each) 40195327209798 (case)
- Lot Numbers: 22HBH009
- 23ABB066
- 22JBX603
- 22JBX483
- 23ABM869
- 22LBB096
- 23EBB528
- 23FBH057
- 3) REF CDS980774M
- UDI/DI 10193489383713 (each) 40193489383714 (case)
- Lot Numbers: 22JBT027
- 23ABE914
- 22KBE813
- 23ABR052
- 23GBL705
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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