The Recall Desk
HighFDA (Devices)·Z-1488-2024·Announced 2024-04-17

Medline SwivAssist Bed Assist Bars Recalled for Safety Standard Non-Compliance

Medline is recalling 79 Bed Assist Bars that failed to comply with federal safety standards for adult portable bed rails. The products were manufactured after the compliance deadline.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II FDA recall of adult portable bed rails that failed to meet mandatory federal safety standards. No injuries have been reported. Bed rails are risk-of-harm products used by potentially vulnerable individuals, and safety-standard non-compliance constitutes a potential injury hazard.

Plain-English summary

Medline Industries is recalling 79 Bed Assist Bars (Adult Portable Bed Rails). The recalled products include the Medline SwivAssist Bar models MDS6800SWIV (sold as cases of 3) and MDS6800SWIVRH (sold individually).

These products were manufactured after a mandatory compliance deadline but failed to meet all requirements of two federal safety standards: 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).

The affected lot numbers are: MDS6800SWIV lots 15123110004, 15123110005, 15124010001, and 15124020002; MDS6800SWIVRH lots 15123110004, 15123110005, and 15123120001. The products were distributed in the United States and Canada.

Consumers who own one of these bed assist bars should stop using them and contact Medline Industries or the FDA for information about return, replacement, or repair.

The recalled product

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)
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • safety-standard-non-compliance
  • structural-failure-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

  • a) Medline SwivAssist Bar
  • Model Number MDS6800SWIV (case of 3)
  • Lot Numbers: 15123110004
  • 15123110005
  • 15124010001
  • 15124020002
  • b) Medline SwivAssist Bar
  • Model Number MDS6800SWIVRH
  • 15123120001

Distribution

Distributed nationwide across the United States.