FDA Device recall Z-1889-2026
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J
- FDA Device
- Class II
- ongoing
- Published 2026-04-29
On 2026-04-29 the FDA classified a Class II recall of Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J by Medline Industries, citing unapproved design changes to the products outside of the 510(k) clearance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1889-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-27 |
| Published | 2026-04-29 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Medline Industries |
| Distribution | US |
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J
Reason
Unapproved design changes to the products outside of the 510(k) clearance.
Identifiers
| code_info | DYNJ0373061J UDI-DI 10889942396856 (EA) 40889942396857 (CS) LOT 24ABR895 |
|---|
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-1889-2026%22
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