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Open, Classified

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTERIOGRAM TRAY 00-402001T, 00-402001U CATH LAB-VEIN PROCEDURES DYNJ60329A CENTRAL VENOUS ACCESS PACK-LF CVI5070 FISTULAGRAM PACK DYNJ66259 INVASIVE LINE INSERTION DYNJ44123C NON VASCULAR PACK DYNJ68037B, DYNJ68037C PICC ABSCESS PACK-LF DYNJ0774005G PICC LINEPACK (PCLUI)642-LF DYNJ47717B PICC PHC DYNJ37484C

FDA Recall Z-1891-2026 · Posted 2026-04-17

Recalling FirmMedline Industries, LP
Recall StatusOpen, Classified
Product CodeOFF
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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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