ModerateClass IIOngoing

FDA Devices recall · Reported June 15, 2022

Nester Embolization Microcoil RPN GPN MWCE-18-5-2-NESTER G52733 MWCE-18-5-3-NESTER G52734 MWCE-18-7-3-NESTER-01 G47338 MWCE-18-7-2-NESTER-01 G47337 MWCE-18-7-5-NESTER-01 G47340 MWCE-18-3-2-NESTER G52731 MWCE-18-7-8-NESTER-01 G47342 MWCE-18-7-8-NESTER G52739 MWCE-18-7-5-NESTER G23521 MWCE-18-3-3-NESTER G52732 MWCE-18-5-3-NESTER-01 G47334 MWCE-18-7-6-NESTER G52738 MWCE-18-7-6-NESTER-01 G47341 MWCE-18-3-3-NESTER-01 G47332 MWCE-18-7-4-NESTER G52

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on June 15, 2022. Severity: Moderate. Recall number: Z-1241-2022.

Q: Where was the recalled product distributed?

Distribution: Domestic distribution nationwide. Foreign distribution worldwide..

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-1241-2022
Affected scope: 106,033
Initiated: May 5, 2022

Compiled from official public sources by the publisher. · Updated September 2026

Verify with FDA Devices →

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Cook Incorporated recalled Nester Embolization Microcoil RPN GPN MWCE-18-5-… - a moderate-severity action.

Nester Embolization Microcoil RPN GPN MWCE-18-5-… 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-1241-2022 with the FDA Devices before acting.

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-1241-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope (see the Recall Profile below) is large enough to require multi-state distribution tracking. Distribution scope (see Distribution below) 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, 6 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 agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.

Product description

Nester Embolization Microcoil RPN GPN MWCE-18-5-2-NESTER G52733 MWCE-18-5-3-NESTER G52734 MWCE-18-7-3-NESTER-01 G47338 MWCE-18-7-2-NESTER-01 G47337 MWCE-18-7-5-NESTER-01 G47340 MWCE-18-3-2-NESTER G52731 MWCE-18-7-8-NESTER-01 G47342 MWCE-18-7-8-NESTER G52739 MWCE-18-7-5-NESTER G23521 MWCE-18-3-3-NESTER G52732 MWCE-18-5-3-NESTER-01 G47334 MWCE-18-7-6-NESTER G52738 MWCE-18-7-6-NESTER-01 G47341 MWCE-18-3-3-NESTER-01 G47332 MWCE-18-7-4-NESTER G52737 MWCE-18-7-3-NESTER G52736 MWCE-18-3-2-NESTER-01 G47331 MWCE-18-5-2-NESTER-01 G47333 MWCE-18-2-2-NESTER-01 G47344 MWCE-18-5-5-NESTER-01 G47335 MWCE-18-7-2-NESTER G52735 MWCE-18-7-4-NESTER-01 G47339 MWCE-18-7-10-NESTER G52741 MWCE-18-5-5-NESTER G23520

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-1241-2022
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-1241-2022) 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-1241-2022.

Where was the recalled product distributed? ▼

Distribution: Domestic distribution nationwide. Foreign distribution worldwide..

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.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

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Same product category, closest by report date among other firms and states (deduped against the severity set).

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This recall: FDA Devices, reported June 15, 2022. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026