Cook Incorporated: Medical Device Recall in 2022 - (Recall #: Z-1826-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-145 (GPN G27041)

Product Classification:

Class II

Date Initiated: August 16, 2022

Date Posted: October 5, 2022

Recall Number: Z-1826-2022

Event ID: 90793

Reason for Recall:

Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

Status: Ongoing

Product Quantity: 43 OUS

Code Information:

TSMB-35-145 (GPN G27041) UDI-DI 00827002270411, Lot 14797970, Expiration Date 16-06-2027

Distribution Pattern:

Domestic distribution nationwide. Foreign distribution worldwide.

Voluntary or Mandated:

Voluntary: Firm initiated