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FDAClass II · Medical device · Recalled July 1, 2026
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP
Hazard: Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Class II: may cause temporary or medically reversible health consequences.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- Z-2588-2026
- Brand
- Medline Industries
- Classification
- Class II
- Units affected
- 113,843 kits
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. MAJOR BASIN SET DYNJ85723
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
- DYNJ85723 UDI-DI 10195327538491 Lot 24ABO130
- Distribution
- US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI, WY and the country of Barbados.
- Firm notified the public via
- Letter
- FDA event ID
- 99062
- Recall initiated
- February 27, 2026
- FDA classified
- June 25, 2026
- FDA report date
- July 1, 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 23, 2026 at 11:04 PM UTC.
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