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FDA Medical Device Recalls (openFDA)

Invacare Corporation: Assist Bed Rail - 6632

Recall number
Z-2218-2017
Recalling firm
Invacare Corporation
Product
Assist Bed Rail - 6632
Status
Terminated
Initiated
2017-04-25
Posted
2017-06-01
Terminated
2018-01-16
Reason
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.
Root cause
Under Investigation by firm
Action
On 4/28/2017 the firm sent Urgent Medical Device Correction letters to their customers.
Quantity
5,020 Units
Distribution
Product was shipped to all US states plus the District of Columbia. Product was also shipped to Canada and Australia.
Lot, serial or model codes
MN: 6632; Date Code begging with FT150701 through FT170228
510(k) numbers
not on file
PMA numbers
not on file
Product code
N/A
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

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