CLASS II ONGOING Device recall · Reported 15 Apr 2026 · FDA Enforcement Report

Medical Approach Cto-18 Micro Wire Guide, Reference recalled

Cook Incorporated is recalling Cook Medical Approach Cto-18 Micro Wire Guide, Reference. The recall was initiated on 5 Mar 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesReference Part Number CMW-14-190-18G, UDI (01)00827002507883(17)290214(10)15898546X, Lot Number 15898546X; Reference Part Number CMW-14-190-18G, UDI (01)00827002507883(17)270115(10)15660224, Lot Number 15660224; Reference Part Number CMW-14-300-18G, UDI (01)00827002507920(17)260718(10)15220204, Lot Number 15220204.

Quantity recalled75 units

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-1777-2026
FDA event ID: 98495
Recalling firm: Cook Incorporated, Bloomington, IN
Classification: Class II
Status: Ongoing
Recall initiated: 5 Mar 2026
FDA classified: 6 Apr 2026
Reported: 15 Apr 2026
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

5 Mar 2026	Recall initiated by company
6 Apr 2026	Classified by FDA	+32 days
15 Apr 2026	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Product as listed by the FDA

COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number G50792

Where it was distributed

Worldwide distribution.

Questions about this recall

Is Medical Approach Cto-18 Micro Wire Guide, Reference recalled?

Yes. Cook Incorporated recalled Medical Approach Cto-18 Micro Wire Guide, Reference on 5 Mar 2026. The recall is Class II and its status is Ongoing. Recall number Z-1777-2026.

Why was it recalled?

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Which lots are affected?

Reference Part Number CMW-14-190-18G, UDI (01)00827002507883(17)290214(10)15898546X, Lot Number 15898546X; Reference Part Number CMW-14-190-18G, UDI (01)00827002507883(17)270115(10)15660224, Lot Number 15660224; Reference Part Number CMW-14-300-18G, UDI (01)00827002507920(17)260718(10)15220204, Lot Number 15220204.

Where was it sold?

Worldwide distribution.

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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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