Z-1488-2024 Class II Ongoing
FDA device recall Z-1488-2024 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Mar 5, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 79 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 17, 2024
- Initiation Date
- Mar 5, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 79 devices
Product Description
Bed Assist Bars, labeled as follows: a) Medline SwivAssist Bar, Model Number MDS6800SWIV (case of 3), b) Medline SwivAssist Bar, Model Number MDS6800SWIVRH (individual)
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Canada.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1488-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026