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U.S. Department of Health and Human Services

Class 2 Device Recall Medline, Martha Stewart

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  Class 2 Device Recall Medline, Martha Stewart see related information
Date Initiated by Firm March 05, 2024
Date Posted April 05, 2024
Recall Status1 Open3, Classified
Recall Number Z-1488-2024
Recall Event ID 94210
Product Classification Adult Portable Bed Rails for Medical Purposes - Product Code QTC
Product Bed Assist Bars, labeled as follows:
a) Medline SwivAssist Bar, Model Number MDS6800SWIV (case of 3),
b) Medline SwivAssist Bar, Model Number MDS6800SWIVRH (individual)
Code Information a) Medline SwivAssist Bar, Model Number MDS6800SWIV (case of 3), Lot Numbers: 15123110004, 15123110005, 15124010001, 15124020002; b) Medline SwivAssist Bar, Model Number MDS6800SWIVRH, Lot Numbers: 15123110004, 15123110005, 15123120001
Recalling Firm/
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact Karin Johnson
Manufacturer Reason
for Recall
Medline is recalling certain lots of our Adult Portable Bed Rails that were manufactured after the mandatory compliance requirement (ASTM F3186-17, Standard Specification for Adult Portable Bed Rails and Related Products and 16 CFR Part 1270, Safety Standard for Adult Portable Bed Rails) and failed to meet all mandatory requirements outlined in these standards.
FDA Determined
Cause 2
Under Investigation by firm
Action Medline Industries, LP issued a Medical Device Recall Notice to its consignees on 03/05/2024 via USPS first class mail and email. The notice explained the issue with the device and requested the consignee destroy the device. Distributors were directed to notify their customers.
Quantity in Commerce 79 devices
Distribution Worldwide distribution - US Nationwide and the country of Canada.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.