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Open, Classified

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT PACK DYNJ50783B ANGIO PHC DYNJ37485C C.I.C.N. ANGIO PACK DYNJ53064B FHT P NEURO PACK DYNJ39931D NEURO ARTERIOGRAM PACK-LF DYNJ0948060F NEURO KIT NAM0003 NEURO PACK DYNJ61542D NEURO RADIOLOGY PACK DYNJ59903B NEURO TRAY DYNJ84872A PK, CATH LAB-ANGIO DYNJ44027F QVH IR NEURO PACK DYNJ62176

FDA Recall Z-1884-2026 · Posted 2026-04-17

Recalling FirmMedline Industries, LP
Recall StatusOpen, Classified
Product CodeOJG
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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