FDA Device recall Z-1101-2026
Portex Spinal Tray, Item No. A3729-24 A3595
- FDA Device
- Class II
- ongoing
- Published 2026-01-21
On 2026-01-21 the FDA classified a Class II recall of Portex Spinal Tray, Item No. A3729-24 A3595 by Icu Medical, citing affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1101-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-19 |
| Published | 2026-01-21 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Icu Medical |
| Distribution | US |
Product
Portex Spinal Tray, Item No. A3729-24 A3595
Reason
Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.
Identifiers
| code_info | 1. A3729-24 UDI-DI 30351688075691 Lots 6146204 (corrected on 1/22/26, removed "-LSM" suffix. 2. A3595 UDI-DI 35019517108211 Lot 6157980 |
|---|
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-1101-2026%22
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