The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0161-2022·Announced 2021-10-27

Easi-Care Gait Belt Metal Buckle may fail at lower loads than rated

Kinsman Enterprises is recalling approximately 13,123 Easi-Care Gait Belts because the metal buckle may fail at loads below the labeled 600-pound capacity, creating a fall risk for users.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 with a documented structural defect in critical patient safety equipment. Although no injuries or hospitalizations are reported in the source material, a gait belt that fails to support users at its rated weight capacity presents a significant risk of falls and injury. Per the rubric, risk-of-harm products where injury has not yet been reported warrant a High (3) severity rating.

Plain-English summary

Kinsman Enterprises Inc is recalling approximately 13,123 units of the Easi-Care Gait Belt Metal Buckle available in 54-inch, 60-inch, and 72-inch lengths. The metal buckle may fail at lower loads than the labeled 600-pound weight capacity, potentially causing users to fall or suffer injury.

The affected products were distributed to healthcare facilities and retailers in California, Florida, Georgia, Illinois, Kentucky, Michigan, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Tennessee, and Virginia.

Consumers and healthcare providers using these gait belts should stop use immediately. Contact Kinsman Enterprises Inc for instructions on how to return or replace the affected product.

The recalled product

Product
Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths)
Manufacturer
Kinsman Enterprises Inc
Category
Medical Device — Mobility Assistance
Hazard
Affected units
13,123

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 (5)

  • Kinsman Product Numbers: 80805 (54")
  • 80806 (60")
  • and 80807 (72") UPC codes: 873704007275
  • 873704006773
  • 873704007282

Distribution

Distributed in 14 states:

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