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RecallWatchMedical Device Safety
Class IIOngoingZ-1886-2026

Medline Industries, LP recalls Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…

Medline Industries, LPNorthfield, IL, United StatesReported Apr 29, 2026 · 2 months ago
Legal News Analyst ·

Reason for recall

Unapproved design changes to the products outside of the 510(k) clearance.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EYE PACK DYNJ35056A HEART CATH PACKDYNJ69318A
    UDI-DI 10889942227563
    24 affected lots
    24ABN639DYNJ69318A101953273707564019532737075723DMD45623EMB84723HMB96923IMC364
    +16 more23JME01123JMI84123LMC38424BMD33324CMB76824CMJ58624EMJ52724GMD97024JMB40824JMI59424KMC7745/20/26DYNJ69318A23FMA84523FMA92425BMF603

What the firm is doing

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.

DistributionShow details

Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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