FDA Device recall Z-2584-2026
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes
- FDA Device
- Class II
- ongoing
- Published 2026-07-01
On 2026-07-01 the FDA classified a Class II recall of Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes by Medline Industries, citing firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2584-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-27 |
| Published | 2026-07-01 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Medline Industries |
| Distribution | US |
Product
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
Reason
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Identifiers
| code_info | DYNJ51124B UDI-DI 10193489579291 Lot 24ABS353 DYNJ0341174D UDI-DI 10195327437749 Lot 24BBB383 DYNJ667…DYNJ51124B UDI-DI 10193489579291 Lot 24ABS353 DYNJ0341174D UDI-DI 10195327437749 Lot 24BBB383 DYNJ66746 UDI-DI 10193489375527 Lot 24BBD114 DYNJ85702 UDI-DI 10195327536213 Lot 24ABP053 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2584-2026%22
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