FDA Device recall Z-1435-2025
Medline procedure kits labeled as: 1) BILATERAL FACET TRAY, Pack Number DYNJRA0869A
- FDA Device
- Class II
- ongoing
- Published 2025-04-02
On 2025-04-02 the FDA classified a Class II recall of Medline procedure kits labeled as: 1) BILATERAL FACET TRAY, Pack Number DYNJRA0869A by Medline Industries Northfield, citing medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that ma….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1435-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-11 |
| Published | 2025-04-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Medline procedure kits labeled as: 1) BILATERAL FACET TRAY, Pack Number DYNJRA0869A; 2) PAIN MANAGEMENT TRAY-LF, Pack Number DYNJRA1749
Reason
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Identifiers
| code_info | 1) Pack Number DYNJRA0869A, 10889942531059 (each) 40889942531050 (case), Lot Number 20KBD382A; 2) Pack Number DYNJRA1…1) Pack Number DYNJRA0869A, 10889942531059 (each) 40889942531050 (case), Lot Number 20KBD382A; 2) Pack Number DYNJRA1749, 10193489829273 (each) 40193489829274 (case), Lot Number 24CMF477A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1435-2025%22
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