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Open, Classified

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BARIATRIC DYNJ905153M, DYNJ905153N GENERAL LAPAROSCOPY PACK DYNJ81602 LAPAROSCOPY DYNJ905157K, DYNJ905157L LAPAROTOMY PACK DYNJ46675G MAJOR LITHOTOMY PACK DYNJ81607 MAJOR PLUS PACK DYNJ905160O MINOR GENERAL PACK DYNJ81599

FDA Recall Z-1881-2026 · Posted 2026-04-17

Recalling FirmMedline Industries, LP
Recall StatusOpen, Classified
Product CodeFDE
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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