The Recall Desk
HighFDA (Devices)·Z-1487-2024·Announced 2024-04-17

Medline Adult Portable Bed Rails Recalled for Safety Standard Failures

Medline is recalling certain lots of adult portable bed rails that were manufactured after the mandatory compliance date but failed to meet required safety standards, potentially posing a fall risk.

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 an FDA Class II medical device recall with no reported injuries or illnesses. Per the severity rubric, products posing a risk of harm where injury has not yet been reported receive a score of 3 (High). Non-compliance with established safety standards for adult portable bed rails presents a theoretical fall risk.

Plain-English summary

Medline Industries, LP is recalling certain lots of adult portable bed rails sold under two model numbers: Medline Model BA6800 and Medline Martha Stewart Model MDS6800BAMMS. A total of 2,895 devices are affected by this recall.

The recalled bed rails were manufactured after the mandatory compliance requirement date but failed to meet all requirements of the ASTM F3186-17 Standard Specification for Adult Portable Bed Rails and Related Products and the 16 CFR Part 1270 Safety Standard for Adult Portable Bed Rails. These safety standards exist to ensure bed rails provide adequate support and stability. Non-compliance could pose a fall risk to users.

The affected devices were distributed nationwide in the United States and in Canada. The recall is limited to specific lot numbers, which are identified in the FDA recall notice.

For product lot number verification and information on replacement or return procedures, consult Medline Industries or the FDA recall notice.

The recalled product

Product
Bed Assist Bars, labeled as follows: a) Medline, Model Number BA6800, b) Medline Martha Stewart, Model Number MDS6800BAMMS
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Bed Safety
Hazard
Affected units
2,895

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 (20)

  • a) Medline
  • Model Number BA6800
  • Lot Numbers: 88523090002
  • 88523090003
  • 88523100001
  • 88523100002
  • 88523100003
  • 88523110002
  • 88523110003
  • 88523120002
  • 88523120003
  • 88524010002
  • 88524020001
  • 88524020002
  • 88524030001
  • b) Medline Martha Stewart
  • Model Number MDS6800BAMMS
  • Lot Numbers: 39323090001
  • 39323090002
  • 39323100001

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

See all →

Same hazard · fall risk

See all →