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
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
- 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.
Questions about this recall
Is Dolomite Gloss Rollator - intended to support during walking and may also serve as a recalled?
Yes. Invacare recalled Dolomite Gloss Rollator - intended to support during walking and may also serve as a on 15 Jun 2023. The recall is Class II and its status is Ongoing. Recall number Z-2445-2023.
Why was it recalled?
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
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 21 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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