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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-2584-2026
- 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. DR G'S BREAST PACK DYNJ51124B LIPO SUPPLEMENT PACK-LF DYNJ0341174D PLASTIC PACK DYNJ66746 DYNJ85702
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
- DYNJ51124B UDI-DI 10193489579291 Lot 24ABS353 DYNJ0341174D UDI-DI 10195327437749 Lot 24BBB383 DYNJ66746 UDI-DI 10193489375527 Lot 24BBD114 DYNJ85702 UDI-DI 10195327536213 Lot 24ABP053
- 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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