FDA Medical devices recall ·

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate… recall

Recall number
Z-1889-2026
Date
(initiated February 27, 2026)
Company / brand
Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States
Category
Medical devices › Class II
Classification
Class II
Status
Ongoing
Units affected
270,311 total
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

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

Why was it recalled?

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

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

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

Distribution

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

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-1889-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.