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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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Low RiskFDA Device

Teleflex Medical: The device labels are not UDI compliant. The missing UDI compliance information on the labelling is not likely to affect the function/performance of the device itself. Other label information and warnings are unaffected by this labelling.; The device labels are not UDI compliant. The missing UDI compliance information on the labelling would not affect the function/performance of the device itself. Other label information and warnings are unaffected by this labelling.

Agency Publication Date: July 15, 2019
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Affected Products

Product: RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device

GTIN: 14026704645708 Lot/Batch Numbers: 20161005 20161120 20161125 20170105 20170210 20170301 20170401 20170402 20170501 20170601 20170801 20170902 20170904 20171001 20171101 20171201 20180101 20170802 20170701

Lot Numbers:
Numbers
Product: RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device

GTIN: 14026704645715 Lot/Batch Numbers: 20161005 20161120 20161125 20170105 20170210 20170401 20170402 20170501 20170801 20170901 20170902 20170903 20170904 20171101 20170701

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81954
Status: Resolved
Manufacturer: Teleflex Medical
Manufactured In: United States
Units Affected: 2 products (105426 US eaches; 76725 US eaches)

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 · 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.