FDAClass II · Medical device · Recalled April 29, 2026
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EYE 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-1886-2026
- 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 EYE PACK DYNJ35056A HEART CATH PACK DYNJ69318A
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
- DYNJ35056A UDI-DI 10889942227563 (EA) 40889942227564 (CS) LOT 24ABN639 DYNJ69318A UDI-DI 10195327370756 (EA) 40195327370757 (CS) LOTS 23DMD456 23EMB847 23HMB969 23IMC364 23JME011 23JMI841 23LMC384 24BMD333 24CMB768 24CMJ586 24EMJ527 24GMD970 24JMB408 24JMI594 24KMC774 ***Updated 5/20/26 - The following lots were included in the customer letter but not the FDA submission.*** DYNJ69318A lots 23FMA845 23FMA924 25BMF603
- 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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