Medline Medical Procedure Kits Recalled for Dimensional Variation Affecting Outer Canister Fit
Medline Industries is recalling certain C-Section surgical kits due to dimensional variations that could cause difficulty fitting into the outer canister. The recall affects 1,753 units distributed worldwide.
What this means for you
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: Class II device recall with no reported illnesses or injuries. The hazard is a dimensional variation potentially affecting product fit—a precautionary mechanical issue without confirmed harm or high-risk contamination factors.
Plain-English summary
Medline Industries is recalling specific lots of its C-Section CDS medical procedure kits (REF CDS983998C). The recall involves 1,753 units distributed worldwide, including the United States, Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, and Singapore.
The kits are being recalled due to a dimensional variation that has the potential to cause increased difficulty when fitting the kits into the outer canister. No illnesses or injuries have been reported.
The affected lot numbers are: 22HBC905, 22HBZ254, 23ABI006, 23CBJ920, 23EBN740, 23FBT058, 23GBR762, 23GBR790, 23JBN978, and 23KBT038. Healthcare facilities and medical professionals should verify the lot number before using these kits. Questions should be directed to Medline Industries.
The recalled product
- Product
- Medline medical procedure kits labeled as follows: a) C-SECTION CDS, REF CDS983998C
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kit
- Hazard
- dimensional-defect
- fitting-defect
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 (13)
- a) REF CDS983998C
- UDI/DI 40193489776714 (case)
- 10193489776713 (unit)
- Lot Numbers: 22HBC905
- 22HBZ254
- 23ABI006
- 23CBJ920
- 23EBN740
- 23FBT058
- 23GBR762
- 23GBR790
- 23JBN978
- 23KBT038
Distribution
Distributed nationwide across the United States.
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