Medline Endo Kit Recall: Missing Lot and Expiration Date Labels
Medline is recalling Endo Kit models containing Olympus components with missing sterile and manufacturing lot numbers and expiration dates on packaging. Without this labeling, medical facilities cannot verify product expiration or track inventory.
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: FDA Class II medical device recall due to missing required labeling on sterile packaging. No illnesses or injuries reported. The missing lot numbers and expiration dates constitute a labeling defect, which per the rubric falls under 'minor labeling errors' corresponding to Moderate severity.
Plain-English summary
Medline Industries is recalling Endo Kit (Model DYKE1577A, Component Number 57469) containing single-use Olympus biopsy valve components. The affected products are missing sterile and manufacturing lot numbers and expiration dates on the sterile packaging. This information is typically found on the outer box or zipper bag label.
The recall affects kits distributed nationwide in the United States, with specific distribution noted in New York. The affected lot number is 22EBD372, identified by UDI-DI 10193489844115 (individual unit) and 40193489844116 (case).
Without proper lot number and expiration date labeling, medical facilities cannot verify product expiration or identify affected units if problems arise. Facilities currently using these kits should verify the lot number and expiration date information from outer packaging or contact Medline Industries for assistance.
The recalled product
- Product
- ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline Convenience Kits containing Single Use Biopsy Valve MAJ-1555
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- labeling-defect
- missing-lot-number
- missing-expiration-date
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 (3)
- UDI-DI: 10193489844115 (each)
- 40193489844116 (case)
- Lot Number 22EBD372
Distribution
Distributed nationwide across the United States.
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