CLASS II ONGOING Device recall · Reported 30 Aug 2023 · FDA Enforcement Report

Dolomite Gloss Rollator - intended to support during recalled

Invacare is recalling Dolomite Gloss Rollator - intended to support during walking and may also serve as a, distributed nationwide in the US. The recall was initiated on 15 Jun 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial number in the range: 20BHL0002 to 21IHL1910

Quantity recalled586 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2445-2023
FDA event ID: 92645
Recalling firm: Invacare, Elyria, OH
Classification: Class II
Status: Ongoing
Recall initiated: 15 Jun 2023
FDA classified: 23 Aug 2023
Reported: 30 Aug 2023
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

15 Jun 2023	Recall initiated by company
23 Aug 2023	Classified by FDA	+69 days
30 Aug 2023	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Serial number in the range: 20BHL0002 to 21IHL1910

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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