Medline Industries is recalling 100 Medline Endo Kits (SKU DYKE1577A) because the sterile packaging may be missing critical safety information. Affected kits contain a biopsy valve that may lack lot numbers, expiration dates, and sterility indicators on the individual sterile packaging. While this information is printed on the outer box, its absence on internal packs could lead to the use of expired or non-sterile components during medical procedures.
Using medical components without confirmed sterility or expiration dates increases the risk of patient infection or device failure during endoscopic procedures. No injuries or incidents have been reported to date.
Contains Single Use Biopsy Valve MAJ-1555.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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