RecallRadar

FDA Device recall Z-0959-2020

Bentson PTFE Wire Guide, Guidewire, Global Product Number G14589, G14590

On 2020-02-12 the FDA classified a Class II recall of Bentson PTFE Wire Guide, Guidewire, Global Product Number G14589, G14590 by Cook, citing the wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0959-2020
ClassificationClass II
Statusterminated
Initiated2019-01-04
Published2020-02-12
Last updated2026-09-13 11:55 UTC
CompanyCook
DistributionUS

Product

Bentson PTFE Wire Guide, Guidewire, Global Product Number G14589, G14590

Reason

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

Identifiers

code_info7832513 7832514 8062406 8062407 8065988 8065989 8065992 8404354 8404355 8547811 8069648

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0959-2020%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.