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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77128

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 25, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Invacare Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Assist Bed Rail - 6632

Z-2218-2017
Recall number
Z-2218-2017
Initiated
April 25, 2017
Classification
Class II
Status
Terminated
Recalling firm
Invacare Corporation
Quantity
5,020 Units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

MN: 6632; Date Code begging with FT150701 through FT170228

Distribution pattern

Product was shipped to all US states plus the District of Columbia. Product was also shipped to Canada and Australia.