Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported November 11, 2020
Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured from stainless steel. To assist in inserting catheters, introducer sheaths, and other medical devices in vascular applications.
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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Cook Inc. recalled Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide … - a critical-severity action.
Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide … was recalled by Cook Inc. in November 11, 2020. Reason: Affected product was dropped during manufacturing, which may result in a bent wire guide and/or the presence …. Check the official notice for the remedy. Verify recall #Z-0399-2021 with the FDA Devices before acting.
The recall
Cook Inc. issued this critical-severity FDA Devices recall-Affected product was dropped during manufacturing, which may result in a bent wire guide and/or the presence ….
- Critical
- severity level
- 61 units
- affected scope
- Class I
- classification
- November 11, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0399-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0399-2021) was formally reported on November 11, 2020, with the manufacturer initiating the action on October 22, 2020. It is classified under Critical severity (Class I), with a current status of Terminated. Cook Inc. is listed as the recalling firm, operating out of Bloomington, IN. Federal records list the affected scope as 61 units.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: US distribution to AZ, IA, IN, MA, and ND.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
61 units
Related Recalls
6
3 from same agency
Product description
Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured from stainless steel. To assist in inserting catheters, introducer sheaths, and other medical devices in vascular applications.
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0399-2021 |
| Date reported | November 11, 2020 |
| Date initiated | October 22, 2020 |
| Recalling firm | Cook Inc. |
| Firm location | Bloomington, IN |
| Affected scope | 61 units |
| Distribution | US distribution to AZ, IA, IN, MA, and ND. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0399-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured from stainless steel. To assist in inserting catheters, introducer sheaths, and other medical devices in vascular applications.. Recalled by Cook Inc.. Units affected: 61 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 11, 2020. Severity: Critical. Recall number: Z-0399-2021.
Where was the recalled product distributed? ▼
Distribution: US distribution to AZ, IA, IN, MA, and ND..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0399-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 11, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.