FDAFDA · Food and drugs·Recall number Z-0558-2025
ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline Convenience Kits containing Single Use Biopsy Valve MAJ-1555
Published December 4, 2024 · Recall initiated: October 25, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expiration dates on the sterile packaging. The information can be found on the outer box or zipper bag label. Medline is recalling its kits which utilize affected product as a component.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- US Nationwide distribution in the state of NY.
- Lot
- UDI-DI: 10193489844115 (each), 40193489844116 (case); Lot Number 22EBD372
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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