Affected product was dropped during manufacturing, which may result in a bent wire guide and/or the presence of loose foreign matter on the wire guide.
Take action
Contact the company
📍Recalling firmCook Inc.750 N Daniels Way · Bloomington, IN 47404-9120
“Cook Fixed Core Wire Guide Recall: Bent Wire or Foreign Matter Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64066-cook-fixed-core-wire-guide-recall-bent-wire-or-foreign. Based on FDA recall #Z-0399-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0399-2021%22&limit=1).
The FDA announced on Oct. 22, 2020, that Cook Inc. voluntarily recalled its Fixed Core Wire Guide due to potential bending and loose foreign matter hazards. The agency issued recall number Z-0399-2021 for the Class I device.
According to the FDA, affected products were dropped during manufacturing, which may result in a bent wire guide and/or the presence of loose foreign matter on the wire guide.
Context
GovInfoNow's records show Cook Inc. has 38 other recalls on record since July 31, 2017. Other recent recalls include the Nov. 12, 2021 Cook Flexor Check-Flo Introducer Ansel Modification and the Oct. 13, 2021 Cook Skinny Needle with Chiba Tip Recall. Similar product recalls from the brand include the March 5, 2026 Cook Medical Approach CTO-18 Micro Wire Guide and the Nov. 26, 2025 Cook Flexor Check-Flo Introducers and Sets.
How to tell if you have this one
Check for the model number RPN TSCF-35-260-3 and lot number 13199931. The product has a PTFE coating and is made of stainless steel.
Brand
Cook
Product
Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the model number RPN TSCF-35-260-3 and lot number 13199931 on the product label.
Where it went and when
Where it was distributed
Distributed in 5 states.
Listed by the agency
Not listed
FDA distribution: “US distribution to AZ, IA, IN, MA, and ND.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, Indiana, Iowa, Massachusetts, North Dakota.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0399-2021 (October 22, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0399-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.