Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J
FDA Recall Z-1889-2026 · Posted 2026-04-17
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Recalling FirmMedline Industries, LP
Recall StatusOpen, Classified
Product CodeKKX
Date Initiated2026-02-27
Product Quantity270,311 total
Reason for Recall
Unapproved design changes to the products outside of the 510(k) clearance.
Firm Action
On February 27, 2026, the firm began notifying customers via email and first-class mail.
Customers were instructed to request over-labels to place on affected kits containing recalled syringes instructing them to remove the recalled component and replace with product from their supply.
Root Cause
Component change control
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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