ModerateClass IITerminated

FDA Devices recall · Reported November 27, 2019

EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector , RX Only, Sterile EC, Made in Mexico, UDI: 00690103172119 for the following REF #s (UDI): EZC21A (00690103174182), EZC21TA (00690103174199), EZC24A (00690103714401), EZC24TA (00690103714418), EZF21A (00690103175080), EZF21TA (00690103175097), EZF24A (00690103175066), EZF24TA (00690103175073), EZS21A (00690103172096), EZS21TA (00690103172102), EZS24A (00690103172119), and EZS24TA (0069

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on November 27, 2019. Severity: Moderate. Recall number: Z-0420-2020.

Q: Where was the recalled product distributed?

Distribution: Worldwide distribution - US Nationwide distribution in the states of Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Washington DC, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Washington DC, Wisconsin, West Virginia, Wyoming and countries of Austria, Australia, Belgium, Bahrain, Canada, Switzerland, Chile, China, Cyprus, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hungary, Canary Islands, Ireland, India, Iceland, Italy, Japan, Mauritius, Malaysia, Netherlands, Norway, Poland, Romania, Sweden, Singapore, Slovakia, Thailand, Turkey, United Arab Emirates, South Africa..

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.

Their is a possibility that the cannula may separate from its connector, potentially causing a breach of circuit during cardiopulmonary bypass which could result in significant bl…

Recall #: Z-0420-2020
Affected scope: 62,431 units
Initiated: October 22, 2019

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

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Edwards Lifesciences, LLC recalled EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector … - a moderate-severity action.

EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector … was recalled by Edwards Lifesciences, LLC in November 27, 2019. Reason: Their is a possibility that the cannula may separate from its connector, potentially causing a breach of circ…. Check the official notice for the remedy. Verify recall #Z-0420-2020 with the FDA Devices before acting.

The recall

Edwards Lifesciences, LLC issued this moderate-severity FDA Devices recall-Their is a possibility that the cannula may separate from its connector, potentially causing a breach of circ….

Moderate
severity level: 62K units
affected scope: Class II
classification: November 27, 2019
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0420-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. 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

EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector , RX Only, Sterile EC, Made in Mexico, UDI: 00690103172119 for the following REF #s (UDI): EZC21A (00690103174182), EZC21TA (00690103174199), EZC24A (00690103714401), EZC24TA (00690103714418), EZF21A (00690103175080), EZF21TA (00690103175097), EZF24A (00690103175066), EZF24TA (00690103175073), EZS21A (00690103172096), EZS21TA (00690103172102), EZS24A (00690103172119), and EZS24TA (00690103172126) Product Usage: Aortic perfusion cannulae are intended for perfusion of the ascending aorta during short-term (< 6 hours) cardiopulmonary bypass procedures. Aortic cannulae in sizes 6 Fr. (2 mm) to 18 Fr. (6 mm) can be used in pediatric patient populations.

Reason for recall

Their is a possibility that the cannula may separate from its connector, potentially causing a breach of circuit during cardiopulmonary bypass which could result in significant blood loss.

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	Terminated
Recall number	Z-0420-2020
Date reported	November 27, 2019
Date initiated	October 22, 2019
Recalling firm	Edwards Lifesciences, LLC
Firm location	Irvine, CA
Affected scope	62,431 units
Distribution	Worldwide distribution - US Nationwide distribution in the states of Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Washington DC, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentuck…

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

Scale of Impact

62,431 units units affected - limited or regional distribution scale.

Regional (<10K units) -

Multi-state (10K – 100K units) ✓ This recall

Large-scale (100K – 1M units) -

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-0420-2020) 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? ▼

Their is a possibility that the cannula may separate from its connector, potentially causing a breach of circuit during cardiopulmonary bypass which could result in significant blood loss.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on November 27, 2019. Severity: Moderate. Recall number: Z-0420-2020.

Where was the recalled product distributed? ▼

Distribution: Worldwide distribution - US Nationwide distribution in the states of Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Washington DC, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Washington DC, Wisconsin, West Virginia, Wyoming and countries of Austria, Australia, Belgium, Bahrain, Canada, Switzerland, Chile, China, Cyprus, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hungary, Canary Islands, Ireland, India, Iceland, Italy, Japan, Mauritius, Malaysia, Netherlands, Norway, Poland, Romania, Sweden, Singapore, Slovakia, Thailand, Turkey, United Arab Emirates, South Africa..

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

Same archive severity grade (Moderate), closest by report date among other firms and states.

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Similar Medical Devices · nearest report date

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

SOMATOM go.Top, Models 11061640 & 1106164… 2019-11-27 EPISTAXIS TRAY Kit Code: MNS10165 2019-11-27 YNHH SCOPE KIT Kit Code: MNS10475 2019-11-27 NOSEBLEED TRAY Kit Code: MNS3885 2019-11-27

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This recall: FDA Devices, reported November 27, 2019. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026