Food, drugs, devices › Invacare Corporation

Device recall: DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. Model Number(s): 1654

FDA enforcement event 92645 · Class II · initiated 15 Jun 2023 · status Ongoing

DeviceVoluntary: Firm initiated1 product recordElyria, OH

FDA enforcement event 92645 is a device recall by Invacare Corporation of Elyria, OH, initiated 15 Jun 2023 and classified Class II, with 1 product record.

FDA defines Class II as 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. 88% of the 917 device enforcement events initiated in 2023 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. Invacare Corporation has 26 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Invacare Corporation, Elyria, OH.

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"

Distribution

"US Nationwide distribution."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-2445-2023	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	586 devices	Class II	Ongoing	30 Aug 2023

Context

88%of 2023 device events are Class II917 events that year

1product record in this eventfirm median: 1

26events on this register for the firm

Other enforcement events for Invacare Corporation

Initiated	Product (first record)	Type	Class	Records
22 Jan 2024	Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model Numbers: (1) G50 (2) G53 (3) G54 (4)	Device	Class II	1
10 Jun 2022	Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)	Device	Class III	1
30 Mar 2022	Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V	Device	Class II	1
12 Nov 2021	Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Mod	Device	Class II	3
30 Oct 2020	Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring supplemental oxygen	Device	Class II	1
16 Nov 2018	Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P The intended use of a Non-AC-Powered patient	Device	Class II	1
25 Apr 2017	Assist Bed Rail - 6632	Device	Class II	1
2 Dec 2016	Bariatric Bed - BAR600IVC	Device	Class II	4
21 Jun 2016	lnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16. Packed one per carton. The lnvacare Precise Rx Pediatric	Device	Class II	2
15 Mar 2016	Invacare¿ Bariatric Bed w/o mattress & rails, Junction Boxes, Product Usage: The Invacare Bariatric home care bed is int	Device	Class II	4

All 26 events for Invacare Corporation

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "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"

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. 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.

Where was the product distributed?

FDA's distribution pattern field reads: "US Nationwide distribution."

Is the recall still ongoing?

FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.