FDAClass II · Medical device · Recalled April 29, 2026
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU recall — Medline Industries, LP
Hazard: Unapproved design changes to the products outside of the 510(k) clearance.
Class II: may cause temporary or medically reversible health consequences.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- Z-1885-2026
- Brand
- Medline Industries
- Classification
- Class II
- Units affected
- 270,311 total
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU DAVINCI PACK - LF DYNJ909398A ROBOTIC PACK DYNJ908706D
Affected products
Companies & origin
- Recalling firm location
- Northfield, IL, United States
- Firm address
- 3 Lakes Dr, N/A, 60093-2753
Identifying details (verbatim from the notice)
- Product codes / lots
- DYNJ909398A UDI-DI 10195327338190 (EA) 40195327338191 (CS) LOTS 24GMH510 24HMG886 DYNJ908706D UDI-DI 10198459017773 (EA) 40198459017774 (CS) LOTS 24HMA783 24HMG308 24KMC651 24KMJ274 24LME931 25AME217 25BMI653 ***Updated 5/20/26 - The following lots were included in the customer letter but not in the FDA submission.*** DYNJ909398A lots 23EMF078 23HME512 23HMI269 23JMB528 23KME175 24EMC327
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
- Firm notified the public via
- Letter
- FDA event ID
- 98601
- Recall initiated
- February 27, 2026
- FDA classified
- April 17, 2026
- FDA report date
- April 29, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.
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