FDA Device recall Z-0347-2025
Approach Hydro ST Micro Wire Guide
- FDA Device
- Class II
- ongoing
- Published 2024-11-20
On 2024-11-20 the FDA classified a Class II recall of Approach Hydro ST Micro Wire Guide by Cook, citing affected device lots have labels that state the incorrect expiration dates.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0347-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-08 |
| Published | 2024-11-20 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Cook |
| Distribution | US |
Product
Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-300-ST
Reason
Affected device lots have labels that state the incorrect expiration dates.
Identifiers
| code_info | RPN /UDI-DI/ Lots: HMW-14-135-ST/ 00827002529373/ 15735501 15765954 15863269 15874634 15907468 15943872 15943886 159717…RPN /UDI-DI/ Lots: HMW-14-135-ST/ 00827002529373/ 15735501 15765954 15863269 15874634 15907468 15943872 15943886 15971771 15974437 16012937 15971771X 16012937X HMW-14-190-ST/ 00827002529380/ 15726043 15726044 15765947 15765955 15778260 15800165 15800166 15811656 15811657 15821245 15829376 15831156 15835857 15849644 15858389 15874633 15885580 15891903 15894221 15894222 15907469 15908739 15943873 15943874 15943881 15943882 15945799 15945801 15952502 15971778 15971779 15979320 15988603 15999088 15999089 16018914 16018917 16018919 15874633X 16018919X NS15765956 NS15769470 NS15783001 NS15794893 NS15802918 NS15821246 NS15835858 NS15849643 NS15915900 NS16029493 HMW-14-300-ST/ 00827002529397/ 15718978 15718979 15720963 15726042 15726045 15731209 15731210 15735502 15765946 15765948 15765949 15765950 15765951 15765952 15765953 15769463 15769464 15769465 15769466 15769467 15769469 15778257 15778258 15778259 15794890 15794891 15800167 15802919 15802920 15802921 15811658 15816909 15816910 15821 |
|---|
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-0347-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.