CLASS II Device recall · Reported 7 Jun 2017 · FDA Enforcement Report
Assist Bed Rail recalled by Invacare
Invacare is recalling Assist Bed Rail - 6632, distributed in District of Columbia. The recall was initiated on 25 Apr 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2218-2017
- FDA event ID
- 77128
- Recalling firm
- Invacare, Elyria, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Apr 2017
- FDA classified
- 1 Jun 2017
- Reported
- 7 Jun 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 25 Apr 2017 | Recall initiated by company | |
| 1 Jun 2017 | Classified by FDA | +37 days |
| 7 Jun 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Assist Bed Rail - 6632
Where it was distributed
Product was shipped to all US states plus the District of Columbia. Product was also shipped to Canada and Australia.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
MN: 6632; Date Code begging with FT150701 through FT170228
Where was it sold?
Product was shipped to all US states plus the District of Columbia. Product was also shipped to Canada and Australia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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