CLASS II ONGOING Device recall · Reported 27 Nov 2024 · FDA Enforcement Report
Approach CTO Micro Wire Guide, RPN CMW-14-190-, GPN G50789 recalled
Cook is recalling Approach CTO Micro Wire Guide, RPN CMW-14-190-, GPN G50789. The recall was initiated on 14 Oct 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0499-2025
- FDA event ID
- 95582
- Recalling firm
- Cook, Bloomington, IN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Oct 2024
- FDA classified
- 21 Nov 2024
- Reported
- 27 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 14 Oct 2024 | Recall initiated by company | |
| 21 Nov 2024 | Classified by FDA | +38 days |
| 27 Nov 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Devices from the affected device lots have labels that state the incorrect expiration dates.
Product as listed by the FDA
Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
Where it was distributed
International Distribution to: Korea only
Questions about this recall
Why was it recalled?
Devices from the affected device lots have labels that state the incorrect expiration dates.
Which lots are affected?
UDI-DI: 00827002507890; Lot Numbers: NS15635381 NS15618280 NS15466311 NS15212224 NS14992020
Where was it sold?
International Distribution to: Korea only
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Cook
All 349| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Beacon Tip Centimeter Sizing Catheter RPN/GPN recalled | Cook | Device Malfunction | Nationwide |
| Device | CLASS I | Aurous Centimeter Sizing Catheter RPN recalled by Cook Incorporated | Cook | Device Malfunction | Nationwide |
| Device | CLASS I | Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-Pig-csc recalled | Cook | Device Malfunction | Nationwide |
| Device | CLASS II | Medical Cook Staged Extubation Set: Reference recalled | Cook | Other | IN |
| Device | CLASS II | Medical Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference recalled | Cook | Other | IN |
Other Other Medical Devices recalls
All 13,884| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NOxBOXi Nitric Oxide Delivery System recalled | Noxbox | Device Malfunction | Nationwide |
| Device | CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled | Percussionaire | Other | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |