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.
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: 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
- Manufacturer
- Medline Industries Inc
- 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
Related recalls
Same manufacturer · Medline Industries Inc
See all →- HighMedline Chest Tube Kit Recalled for Non-Sterile Tape Component
FDA (Devices) · 2022-09-14
- ModerateMedline Hand Sanitizer Foam Recalled for Defective Containers
FDA (Drugs) · 2021-12-29
- ModerateBedside PICC CDS Convenience Kit Recalled for Expired Saline Component
FDA (Devices) · 2021-12-22
- HighMedline Venous Access Pack-LF Recalled for Expired Saline Component
FDA (Devices) · 2021-12-22
- HighEVLP Convenience Pack Recalled for Expired Injectable Component
FDA (Devices) · 2021-12-22
Same hazard · mechanical failure
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- HighMedline Transfer/Gait Belt Recall Due to Locking Mechanism Failure
FDA (Devices) · 2017-11-29
- HighMedline Plastic Transfer Belts Recalled for Locking Mechanism Failure
FDA (Devices) · 2017-11-29
- HighMedline IV Catheter Kits Recalled Over Needle Retraction Issue
FDA (Devices) · 2025-07-09
- HighMedline Medical Convenience Kits Recalled for Syringe Leaks and Breakage
FDA (Devices) · 2024-09-18
- HighMedline Recalls Medical Convenience Kits with Defective Plastic Syringes
FDA (Devices) · 2024-09-18
- HighMedline Recalls Central Line Dressing Change Trays Due to Seal Defects
FDA (Devices) · 2020-09-30