ModerateClass IIOngoing

FDA Devices recall · Reported June 15, 2022

Tornado Embolization Microcoil, RPN GPN MWCE-18S-5/2-TORNADO G08356 MWCE-18S-6/2-TORNADO G08259 MWCE-18S-3/2-TORNADO-01 G47416 MWCE-18S-4/2-TORNADO-01 G47417 MWCE-18S-3/2-TORNADO-081800 G13102 MWCE-18S-3/2-TORNADO G08261 MWCE-18S-4/2-TORNADO-081800 G13103 MWCE-18S-4/2-TORNADO G08357 MWCE-18S-5/2-TORNADO-01 G47418 MWCE-18S-6/2-TORNADO-01 G47419 MWCE-18S-6/2-TORNADO-081800 G13105 MWCE-18S-5/2-TORNADO-081800 G13104 MWCE-18S-2/4-TORNADO-LEF

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on June 15, 2022. Severity: Moderate. Recall number: Z-1242-2022.

Q: Where was the recalled product distributed?

Distribution: Domestic distribution nationwide. Foreign distribution worldwide..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-1242-2022) 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.

Q: 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.

The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.

Recall #: Z-1242-2022
Affected scope: 106,033
Initiated: May 5, 2022

Compiled from official public sources by the editorial team. · Updated July 2026

Verify with FDA Devices →

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Cook Incorporated recalled Tornado Embolization Microcoil, RPN GPN MW… - a moderate-severity action.

Tornado Embolization Microcoil, RPN GPN MW… was recalled by Cook Incorporated in June 15, 2022. Reason: The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.. Check the official notice for the remedy. Verify recall #Z-1242-2022 with the FDA Devices before acting.

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The recall

Cook Incorporated issued this moderate-severity FDA Devices recall-The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula..

Moderate
severity level: 106K units
affected scope: Class II
classification: June 15, 2022
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1242-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-1242-2022) was formally reported on June 15, 2022, with the manufacturer initiating the action on May 5, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. Cook Incorporated is listed as the recalling firm, operating out of Bloomington, IN. Federal records list the affected scope as 106,033, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula. Distribution data in the federal record shows the product reached: Domestic distribution nationwide. Foreign distribution worldwide.. 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.

Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

106,033

Related Recalls

3 from same agency

Product description

Tornado Embolization Microcoil, RPN GPN MWCE-18S-5/2-TORNADO G08356 MWCE-18S-6/2-TORNADO G08259 MWCE-18S-3/2-TORNADO-01 G47416 MWCE-18S-4/2-TORNADO-01 G47417 MWCE-18S-3/2-TORNADO-081800 G13102 MWCE-18S-3/2-TORNADO G08261 MWCE-18S-4/2-TORNADO-081800 G13103 MWCE-18S-4/2-TORNADO G08357 MWCE-18S-5/2-TORNADO-01 G47418 MWCE-18S-6/2-TORNADO-01 G47419 MWCE-18S-6/2-TORNADO-081800 G13105 MWCE-18S-5/2-TORNADO-081800 G13104 MWCE-18S-2/4-TORNADO-LEF G09945 MWCE-18S-2/5-TORNADO-LEF-081800 G13108 MWCE-18S-4/3-TORNADO G12924 MWCE-18S-2/3-TORNADO-LEF G09944 MWCE-18S-2/3-TORNADO-LEF-081800 G13106 MWCE-18S-2/4-TORNADO-LEF-081800 G13107

Reason for recall

The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Ongoing
Recall number	Z-1242-2022
Date reported	June 15, 2022
Date initiated	May 5, 2022
Recalling firm	Cook Incorporated
Firm location	Bloomington, IN
Affected scope	106,033
Distribution	Domestic distribution nationwide. Foreign distribution worldwide.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

106,033 units affected - multi-state distribution scale.

Regional (<10K units) -

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) ✓ This recall

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1242-2022) 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.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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? ▼

Why was this product recalled? ▼

The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on June 15, 2022. Severity: Moderate. Recall number: Z-1242-2022.

Where was the recalled product distributed? ▼

Distribution: Domestic distribution nationwide. Foreign distribution worldwide..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-1242-2022) 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 June 15, 2022. 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.