FDA Device recall Z-2589-2026
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-2589-2026 |
| 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. KIT NEURO CSTM SAMP0551
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 | SAMP0551 UDI-DI 10195327268503 Lots 22JBG593 22JBJ361 |
|---|
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-2589-2026%22
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