Walker, Mechanical

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2024-10-17Open, ClassifiedDevice Design

  Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number: 4329BL Product Description: ROLLING WALKER MOBILITY AID

  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.

• 2024-10-17Open, ClassifiedDevice Design

  Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model/Catalog Number: 4329PL Product Description: ROLLING WALKER MOBILITY AID

  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.

• 2024-10-17Open, ClassifiedDevice Design

  Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description: ROLLING WALKER MOBILITY AID

  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.

• 2024-07-12Open, ClassifiedProcess control

  Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and glide through their daily activities. Model: 791BL (Blue)

  The tiller separates from the base/front caster assembly. If the knee walker fails, a user may fall and sustain an injury

• 2024-07-12Open, ClassifiedProcess control

  Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and glide through their daily activities. Model: 791RD (Red)

  The tiller separates from the base/front caster assembly. If the knee walker fails, a user may fall and sustain an injury

• 2023-11-03Open, ClassifiedProcess design

  BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid.

  Due to walkers not meeting product specifications. Walkers were manufactured with misaligned wheels.

• 2023-08-23Open, ClassifiedDevice Design

  DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. Model Number(s): 1654807 - DOLOMITE GLOSS 680 ROLLATOR 1655081 - DOLOMITE GLOSS 600 ROLLATOR 1655082 - DOLOMITE GLOSS 520 ROLLATOR 1655083 - DOLOMITE GLOSS 450 ROLLATOR

  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

• 2016-10-24TerminatedComponent design/selection

  4205 Journey Rolling Walker Product Usage: used to assist people in walking

  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.

• 2014-11-20TerminatedEmployee error

  MediChoice Dual-Release Folding Walker with 5" wheel

  Product wheels may be too loose, too tight, or fall off.

• 2014-11-12TerminatedDevice Design

  Transport Rollator with Padded Seat; Large 8-inch wheels with wheel locks (indoor and outdoor use), fold down footrests, ergonomic handles, curved padded backrest and handy wire basket for storage. Item# 30192 Burgundy each/Item# 30194 Blue each.. Transport Rollator is a wheeled rollator with an additional push bar that can be used to push an end-user for short trips. (Walker, Mechanical)

  The caster may separate completely from the device frame causing injury to user.