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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Surgical Equipment

Westmed Flex Extenders Recalled for Life-Threatening Disconnection Risk

Agency Publication Date: October 30, 2024
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Summary

Westmed, Inc. has recalled approximately 50,050 units of Flex Extenders, which are single-use corrugated plastic tubes used to connect breathing circuits to patient masks or tracheal tubes. The recall was issued because a connector within the circuit may not meet technical specifications, causing it to have a weak connection. This defect can lead to the tube leaking or disconnecting entirely during medical procedures or patient care.

Risk

If the connector fails or disconnects, it could lead to a loss of ventilation or oxygen delivery. This poses a critical risk of life-threatening conditions or death for patients who depend on these breathing circuits.

What You Should Do

  1. This recall involves Westmed Flex Extenders (Catalog Numbers S6411P and 7 5132), which are flexible, corrugated plastic tubes used to connect breathing circuits to a patient's airway interface.
  2. Identify affected units by checking the catalog number and lot number printed on the product packaging or device label. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately to avoid the risk of accidental disconnection or leaks.
  4. Contact Westmed, Inc. or your medical device distributor to arrange for the return, replacement, or correction of the affected units.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for more information regarding this safety alert.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Flex Extenders, 5.2" x 15mm OD x 15mm ID
Variants: 5.2" x 15mm OD x 15mm ID
Model / REF:
S6411P
Lot Numbers:
0004294660
0004289136
0004291318
0004295361
UDI:
00709078012488
10709078012485

Non-invasive, single-use corrugated plastic tubes.

Product: Flex Extender, 5.2" x 15mm OD x 22/15mm ID
Variants: 5.2" x 15mm OD x 22/15mm ID
Model / REF:
7 5132
Lot Numbers:
0004289133
0004289134
0004289135
0004289735
0004289736
0004289737
0004290327
0004290328
0004291315
0004291316
0004291317
0004291790
0004291791
0004292272
0004292273
0004292275
0004292717
0004293127
0004294432
0004294433
0004295069
0004295358
0004295458
UDI:
00709078008405
10709078008402

Non-invasive, single-use corrugated plastic tubes.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95453
Status: Active
Manufacturer: Westmed, Inc.
Sold By: Medical device distributors; Hospitals
Manufactured In: United States
Units Affected: 50,050 units
Distributed To: Alaska, California, Colorado, District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Vermont, Washington, West Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.