FDA Device recall Z-2445-2023
DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat
- FDA Device
- Class II
- ongoing
- Published 2023-08-30
On 2023-08-30 the FDA classified a Class II recall of DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat by Invacare, citing 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 ca….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2445-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-06-15 |
| Published | 2023-08-30 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Invacare |
| Distribution | US |
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
Identifiers
| code_info | Serial number in the range: 20BHL0002 to 21IHL1910 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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FDA Device · Class II · 2022-01-12 · Invacare
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2445-2023%22
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