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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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Medium RiskFDA Device
Medical Devices/Monitoring Devices

Covidien: Puritan Bennett Cuff Pressure Manager Recalled for Power Inlet Port Failure

Agency Publication Date: September 29, 2023
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Summary

Covidien has recalled 408 units of the Puritan Bennett Cuff Pressure Manager (REF: 180-03) because the internal connection for the power inlet can break. This defect causes the charging port to fall into the device housing after several uses, which prevents the battery from charging. If the device cannot be charged, it may fail to operate, potentially leading to critical delays in medical treatment.

Risk

A dislodged power inlet prevents the device from maintaining power, which can stop the management of cuff pressure in patients requiring airway support. This mechanical failure can result in a delay of necessary medical therapy or a loss of device function during use.

What You Should Do

  1. Identify if your device is affected by checking the model number REF: 180-03 and the Unique Device Identifier (UDI-DI) 10884521782495.
  2. Verify your device serial number against the recalled list, which includes series starting with E2235, E2236, E2249, E2250, E2302, E2305, and E2309 (e.g., E223500003 through E230900080).
  3. Inspect the external power inlet port on the device housing to see if it appears loose, pushed in, or dislodged.
  4. Contact your healthcare provider or Covidien immediately to report device issues and to receive instructions regarding repairs or replacements.
  5. For further information or technical support, contact Covidien at their Boulder, Colorado facility or reach out to the FDA at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer corrective action and support

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Puritan Bennett Cuff Pressure Manager, REF: 180-03
Model / REF:
REF: 180-03
UPC Codes:
10884521782495
Lot Numbers (408):
E223500003
E223500004
E223500005
E223500006
E223500007
E223500008
E223500009
E223500010
E223500011
E223500012
E223500013
E223500014
E223500015
E223500016
E223500017
E223500018
E223500019
E223500020
E223500021
E223500022
E223500023
E223500024
E223500025
E223500026
E223500027
E223500028
E223500029
E223500030
E223500031
E223500032
E223500054
E223500055
E223500079
E223500080
E223500081
E223500082
E223500083
E223600009
E223600010
E223600011
E223600012
E223600013
E223600014
E223600015
E223600016
E223600017
E223600018
E223600019
E223600020
E223600021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92941
Status: Active
Manufacturer: Covidien
Sold By: Authorized medical distributors; Direct medical sales
Manufactured In: United States
Units Affected: 408
Distributed To: Alabama, New Jersey, Massachusetts, Michigan, New York, North Carolina, Colorado, Texas, Florida, Kentucky, Utah, California, Arizona, Kansas, Illinois, Tennessee

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.