FDA Medical Device Recalls (openFDA)
Invacare Corporation: 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
- Recall number
- Z-2445-2023
- Recalling firm
- Invacare Corporation
- 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
- Status
- Open, Classified
- Initiated
- 2023-06-15
- Posted
- 2023-08-23
- Terminated
- not on file
- 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
- Root cause
- Device Design
- Action
- Invacare initiated on June 15, 2023 via electronic communications Urgent Medical Device Field Correction to consignees. Letter states reason for recall, health risk and action to take: 1. Review your existing stock to locate, quarantine, and return the affected devices to Invacare. A list of serial numbers is attached to assist in this process. An example product label for is shown below with annotations. 2. For affected Dolomite Gloss rollators already delivered to a customer, please contact the customer immediately to inform them that the Dolomite Gloss rollator(s) that they purchased is/are part of a safety recall and that use of this product should be discontinued immediately. For convenience, we have attached a Customer Letter which you may use to communicate this information with your customer(s). 3. Invacare will work with you to provide a replacement rollator or credit for the affected rollator that is being returned. 4. Complete and return the enclosed Provider Acknowledgement Card by following the instructions on the card. If you do not have an acknowledgement card or require a new one, please contact Invacare at (877) 413-6008 (U.S. Customers), Monday Friday, 8 a.m. 5 p.m. EST, for assistance. 5. You are responsible for ensuring that this field correction is conducted with your customers. Customers who own affected units should be contacted and informed about this field correction. If you have any questions concerning these instructions, please call Invacare s field correction support line at (877) 413-6008 (U.S. Customers), Monday Friday, 8 a.m. 5 p.m. EST, for assistance.
- Quantity
- 586 devices
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Serial number in the range: 20BHL0002 to 21IHL1910
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ITJ
- Firm FEI
- 1525712
- Firm city
- Elyria
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28