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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/Home Healthcare

MEDLINE INDUSTRIES, LP - Northfield: Adult Portable Bed Rails Recalled for Failure to Meet Safety Standards

Agency Publication Date: April 5, 2024
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Summary

Medline Industries is recalling 2,974 Adult Portable Bed Rails and Bed Assist Bars because they failed to meet mandatory federal safety requirements. The affected models include the Medline Bed Assist Bar (BA6800), the Medline Martha Stewart Bed Assist Bar (MDS6800BAMMS), and the Medline SwivAssist Bar (MDS6800SWIV and MDS6800SWIVRH). These products were manufactured after compliance standards were implemented and do not meet the strict safety criteria intended to protect users.

Risk

Bed rails that do not meet mandatory safety standards (ASTM F3186-17 and 16 CFR Part 1270) pose a serious risk of entrapment, where a person can become stuck between the rail and the mattress or bed frame, leading to asphyxiation or other serious injuries. While no specific injuries are mentioned in this report, the failure to meet these standards indicates a significant safety defect.

What You Should Do

  1. Identify your product by checking the model and lot numbers on the device or packaging for Medline Model BA6800, Medline Martha Stewart Model MDS6800BAMMS, or Medline SwivAssist Bar Models MDS6800SWIV and MDS6800SWIVRH.
  2. Check for the following affected lot numbers for the Medline BA6800 and Martha Stewart MDS6800BAMMS: 88523090002, 88523090003, 88523100001, 88523100002, 88523100003, 88523110002, 88523110003, 88523120002, 88523120003, 88524010002, 88524020001, 88524020002, 88524030001, 39323090001, 39323090002, 39323100001, 39323100002, 39323110001, 39323110002, 39323120001, 39323120002, 39324010001, or 39324010002.
  3. Check for the following SwivAssist Bar lot numbers: 15123110004, 15123110005, 15124010001, 15124020002, and 15123120001.
  4. Contact your healthcare provider or Medline Industries directly at 1-800-MEDLINE for further instructions and information regarding a potential refund.
  5. For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Healthcare provider or manufacturer consultation.

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

Affected Products

Product: Medline Bed Assist Bar
Model / REF:
BA6800
Lot Numbers:
88523090002
88523090003
88523100001
88523100002
88523100003
88523110002
88523110003
88523120002
88523120003
88524010002
88524020001
88524020002
88524030001
Product: Medline Martha Stewart Bed Assist Bar
Model / REF:
MDS6800BAMMS
Lot Numbers:
39323090001
39323090002
39323100001
39323100002
39323110001
39323110002
39323120001
39323120002
39324010001
39324010002
Product: Medline SwivAssist Bar (Case of 3)
Model / REF:
MDS6800SWIV
Lot Numbers:
15123110004
15123110005
15124010001
15124020002
Product: Medline SwivAssist Bar (Individual)
Model / REF:
MDS6800SWIVRH
Lot Numbers:
15123110004
15123110005
15123120001

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94210
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Authorized Medline Distributors
Manufactured In: United States
Units Affected: 2 products (2895 devices; 79 devices)
Distributed To: Nationwide

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.