Z-2445-2023Class II

DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. Model...

Name: Z-2445-2023 DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. Model...
Creator: Invacare Corporation
Published: 2023-06-15
License: https://open.fda.gov/license/

Invacare GmbH / initiated 2023-06-15 / Open, Classified / root cause: design

FDA source

Invacare Corporation began a recall of DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. Model Number(s): 1654807 - DOLOMITE GLOSS 680 ROLLATOR... on 2023-06-15. FDA classified it as Class II and gives the reason 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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2445-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-15
Posted: 2023-08-23
Recalling firm: Invacare GmbH
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
Product code: ITJ Walker, Mechanical
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
Root cause tag: design
FDA 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 in commerce: 586 devices
Distribution: US Nationwide distribution.
Product codes and lots: Serial number in the range: 20BHL0002 to 21IHL1910

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2445-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2445-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-30	2023-08-23

Product code ITJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)