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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

R A Medical Services: MINISCAV Vacuum Pump Recalled for Inadequate Documentation

Agency Publication Date: September 20, 2023
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Summary

R A Medical Services has recalled 10 units of the MINISCAV (tm) Vacuum Pump because of inadequate documentation of acceptance activities. This means there is insufficient proof that the devices were properly tested and verified to meet safety and performance standards before being distributed. These vacuum pumps were distributed specifically to Ohio and are identified by serial numbers N/AB/10514 through N/AB/10523.

Risk

Inadequate documentation of acceptance activity means the manufacturer cannot guarantee the device functions correctly or safely, which could potentially lead to device failure or unexpected performance during medical procedures. While no injuries have been reported, the lack of quality control documentation creates a moderate risk that a defective unit could reach a patient or healthcare provider.

What You Should Do

  1. Locate your MINISCAV (tm) Vacuum Pump and check the identification label for UDI/DI (01) 10862552000405.
  2. Verify if your device's serial number is included in the affected range: N/AB/10514 through N/AB/10523.
  3. Contact your healthcare provider or the manufacturer, R A Medical Services, to discuss the status of your equipment and receive further instructions on its continued use or return.
  4. For additional information, you may contact the manufacturer directly or reach out to the FDA's medical device line at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Contact Manufacturer

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

Affected Products

Product: MINISCAV (tm) Vacuum Pump
Lot Numbers:
Serial numbers: N/AB/10514 through N/AB/10523

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92929
Status: Active
Manufacturer: R A Medical Services
Manufactured In: United Kingdom
Units Affected: 10 units
Distributed To: Ohio

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.