Recall Z-2445-2023— Invacare Corporation

Name: FDA recall Z-2445-2023
Creator: U.S. Food and Drug Administration
Published: 2023-06-15

Class II · Ongoing

Class II FDA medical device recall by Invacare Corporation, initiated 2023-06-15. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: 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.

Recalling firm: Invacare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2023-06-15
Firm location: Elyria, OH, United States

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.