Walker, Mechanical
Physical Medicine · 21 CFR 890.3825
Recent MDR events
10,673 adverse event reports on file
- MEDLINEJul 31, 2026MalfunctionMedline Industries, Lp1417592-2026-12116
- MEDLINEJul 31, 2026MalfunctionMedline Industries, Lp1417592-2026-12117
- MEDLINEJul 31, 2026MalfunctionMedline Industries, Lp1417592-2026-12123
- MEDLINEJul 31, 2026MalfunctionMedline Industries, Lp1417592-2026-12124
- MEDLINEJul 31, 2026MalfunctionMedline Industries, Lp1417592-2026-12126
- MEDLINEJul 31, 2026MalfunctionMedline Industries, Lp1417592-2026-12127
- MEDLINEJul 31, 2026MalfunctionMedline Industries, Lp1417592-2026-12134
- MedlineJul 31, 2026MalfunctionMedline Industries, Lp1417592-2026-08081
- MEDLINEJul 31, 2026MalfunctionMedline Industries, Lp1417592-2026-12142
- MEDLINEJul 31, 2026MalfunctionMedline Industries, Lp1417592-2026-12149
Event type breakdown
Recalls
27 recall events for this product code
- Nova Ortho-Med IncOpen, ClassifiedOct 17, 2024
Brand Name: NOVA ORTHO-MED INC.
Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slouched seated position to an upright seated position, there is the potential for the movement to cause the backrest to lift out of the backrest holder and disengage from the unit.
Z-0129-2025 · View FDA record ↗ - Nova Ortho-Med IncOpen, ClassifiedOct 17, 2024
Brand Name: NOVA ORTHO-MED INC.
Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slouched seated position to an upright seated position, there is the potential for the movement to cause the backrest to lift out of the backrest holder and disengage from the unit.
Z-0130-2025 · View FDA record ↗ - Nova Ortho-Med IncOpen, ClassifiedOct 17, 2024
Brand Name: NOVA ORTHO-MED INC.
Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slouched seated position to an upright seated position, there is the potential for the movement to cause the backrest to lift out of the backrest holder and disengage from the unit.
Z-0131-2025 · View FDA record ↗ - Medical Depot Inc.Open, ClassifiedJul 12, 2024
Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and glide through their daily activities.
The tiller separates from the base/front caster assembly. If the knee walker fails, a user may fall and sustain an injury
Z-2354-2024 · View FDA record ↗ - Medical Depot Inc.Open, ClassifiedJul 12, 2024
Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and glide through their daily activities.
The tiller separates from the base/front caster assembly. If the knee walker fails, a user may fall and sustain an injury
Z-2355-2024 · View FDA record ↗ - Breg IncOpen, ClassifiedNov 3, 2023
BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS
Due to walkers not meeting product specifications. Walkers were manufactured with misaligned wheels.
Z-0231-2024 · View FDA record ↗ - Invacare CorporationOpen, ClassifiedAug 23, 2023
DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat.
Premature failure of the seat during use, the plastic eyelets of the folding mechanism of the device's seat can break, and in a worst-case crossbar also breaks and the Rollator can collapse causing injury to user
Z-2445-2023 · View FDA record ↗ - Nova Ortho-Med IncTerminatedOct 24, 2016
4205 Journey Rolling Walker
Nova Medical is recalling the Journey Rolling Walker because the screws used to hold the black side support pieces to the frame can become loose over time. This can result in the locking nut coming off and the screw falling out.
Z-0304-2017 · View FDA record ↗ - Owens & Minor Distribution, Inc.TerminatedNov 20, 2014
MediChoice Dual-Release Folding Walker with 5" wheel
Product wheels may be too loose, too tight, or fall off.
Z-0416-2015 · View FDA record ↗ - Roscoe Medical IncTerminatedNov 12, 2014
Transport Rollator with Padded Seat; Large 8-inch wheels with wheel locks (indoor and outdoor use), fold down footrests, ergonomic handles, curved padded backre
The caster may separate completely from the device frame causing injury to user.
Z-0204-2015 · View FDA record ↗
Registered firms
344 firms currently registered for this product code
Avivo Life, Llc
Rockville, MD, US
Jiangsu Andycare Medical Products Co.,ltd.
Zhenjiang Jiangsu, CN
Premier Guard Zhongshan Limited
Zhongshan Guangdong, CN
Fortune Company Ltd.
Huizhou Guangdong, CN
Yang-tze Healthcare Products Co, Limited
Dongguan City Guangdong, CN
Hangzhou Fuyang Hongwei Metal Product Limited Company
Hangzhou City Zhejiang, CN
Mor-medical International
Pharr, TX, US
Foshan Zubon Technology Co.,ltd.
Foshan City Guangdong, CN
Blickman Industries Llc
Lawrenceburg, TN, US
Shenzhen Enhanced Power Technology Co., Ltd.
Shenzhen Guangdong, CN
Taicang Jingquan Metal Products Co., Ltd
Taicang Jiangsu, CN
Zhongshan Carestart Medical Co., Ltd.
Zhongshan Guangdong, CN
Sichuan Ast Medical Equipment Co., Ltd
Luzhou City Sichuan, CN
Genemax Medical Products Industry Corp.
TAICHUNG CITY, TW
Shanghai Mu Promotions Co., Ltd.
Shanghai, CN
Zhongshan Qunn Medical Equipment Co., Ltd.
Zhongshan City Guangdong, CN
Arjohuntleigh Polska Sp. Zo.o.
Poznan Wielkopolskie, PL
Amylior, Inc.
Vaudreuil-Dorion Quebec, CA
Zhongshan Sunneo Medical Instruments Co.,ltd
Zhongshan Guangdong, CN
M2 Global Co., Ltd.
Ho Chi Minh City Binh Duong, VN
Zhongshan Ruiren Medical Technology Co.,ltd
Zhongshan Guangdong, CN
P.c.p. Champion
RIPLEY, OH, US
Mobility Source Medical Technology Co., Ltd.
Foshan Guangdong, CN
Bliss Health Products Co., Ltd.
Zhongshan City Guangdong, CN
Nova Ortho-med, Inc.
North Aurora, IL, US
510(k) clearances
14 clearances for this product code
- Kaye Products, Inc.Nov 29, 1983
K833869 · CHILD'S WALKER
- Convaid Products, Inc.Oct 27, 1983
K833195 · UMBRELLA WALKER
- Meta-MorrisMay 25, 1983
K830784 · WALK N ROLL
- Lic-OrthionApr 5, 1983
K830848 · RESI-WALKER
- Orthion Corp.Nov 5, 1982
K823105 · RESI-WALKER
- Manuco Manufacturing Co., Inc.May 21, 1982
K821404 · LIGHT WEIGHT ALUMINUM WALKER
- Walk-A-Cycle DivisionApr 8, 1982
K820711 · WALK-A-CYCLE
- Fred Sammons, Inc.Jun 16, 1981
K811485 · WALKER/CRUTCH BAG