The Recall Desk
HighFDA (Devices)·Z-0055-2021·Announced 2020-10-14

Medline Recalls Quick Release Gait Belts Due to Buckle Breakage Risk

Medline Industries is recalling 13,500 Quick Release Gait Belts because the buckle may break due to material degradation from gamma radiation exposure.

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: The recall is classified as FDA Class II and involves a risk-of-harm product (gait belt buckle failure) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Medline Industries Inc is recalling 13,500 units of the Quick Release Gait Belt, Model MDT821208NATM /503689. The affected lots are 33019040001, 33019090001, and 33019100001. These belts were also used in kits with model number DYKF1045, lots 20EBB832 and 20EBM643.

The recall is being issued because the buckle on the gait belt may break. This potential failure is attributed to the degradation of the material caused by exposure to gamma radiation. The agency has classified this as a Class II recall.

The product was distributed domestically in Illinois and Michigan. No specific illnesses or injuries are reported in the source text. Consumers and healthcare facilities should stop using the affected belts and contact Medline Industries for instructions on return or replacement.

The recalled product

Product
Quick Release Gait Belt, 60
Affected units
13,500

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 (1)

  • Model: MDT821208NATM /503689 Lots: 33019040001

Distribution

Distributed in 2 states: