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Recall Observatory FDA recall evidence

Device product

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J

Z-1889-2026

February 27, 2026

Class II

Product summary

Firm
Medline Industries, LP
Event
Event 98601
Status
Ongoing
Classification
Class II
Quantity
270,311 total
Official record key
device-enforcement:Z-1889-2026

Official wording

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

Code information: DYNJ0373061J UDI-DI 10889942396856 (EA) 40889942396857 (CS) LOT 24ABR895

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

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Unapproved design changes