Z-2218-2017Class II

Assist Bed Rail - 6632

Name: Z-2218-2017 Assist Bed Rail - 6632
Creator: Invacare Corporation
Published: 2017-04-25
License: https://open.fda.gov/license/

Invacare GmbH / initiated 2017-04-25 / Terminated

FDA source

Invacare Corporation began a recall of Assist Bed Rail - 6632 on 2017-04-25. FDA classified it as Class II and gives the reason as "A typographical error was noted within the user manual for the 6632 Assist Bed Rail which could result in the Assist Bed Rails being installed incorrectly". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2218-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-25
Posted: 2017-06-01
Terminated: 2018-01-16
Recalling firm: Invacare GmbH
Product: Assist Bed Rail - 6632
Product code: N/A
Reason for recall: A typographical error was noted within the user manual for the 6632 Assist Bed Rail which could result in the Assist Bed Rails being installed incorrectly.
FDA root cause: Under Investigation by firm
Action: On 4/28/2017 the firm sent Urgent Medical Device Correction letters to their customers.
Quantity in commerce: 5,020 Units
Distribution: Product was shipped to all US states plus the District of Columbia. Product was also shipped to Canada and Australia.
Product codes and lots: MN: 6632; Date Code begging with FT150701 through FT170228

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2218-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2218-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-07	2017-06-01

Product code N/A

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)