FDA Device recall Z-0499-2025
Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
- FDA Device
- Class II
- ongoing
- Published 2024-11-27
On 2024-11-27 the FDA classified a Class II recall of Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789 by Cook, citing devices from the affected device lots have labels that state the incorrect expiration dates.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0499-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-14 |
| Published | 2024-11-27 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Cook |
| Distribution | n/a |
Product
Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
Reason
Devices from the affected device lots have labels that state the incorrect expiration dates.
Identifiers
| code_info | UDI-DI: 00827002507890; Lot Numbers: NS15635381 NS15618280 NS15466311 NS15212224 NS14992020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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FDA Device · Class I · 2026-05-13 · Cook - Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-0-CSC-20 G31214 NR5.0-35-100-P-10S-PIG-C…
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FDA Device · Class II · 2026-04-15 · Cook
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0499-2025%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.