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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85870

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

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Event summary

Timeline bucket
June 09, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
EHOB, Inc.

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

Expansion Control Overlay, Item No. 1004EC - Product Usage: The EHOB WAFFLE Overlay is more than a support surface, assisting in lateral transfers, boosts and turns to protect patients throughout the hospital journey. Through immersion and envelopment, the WAFFLE Overlay is designed to offload the patient and relieve pressure at bony prominences while the unique venting holes allow for air circulation to keep patients cool, dry and comfortable.

Z-2640-2020
Recall number
Z-2640-2020
Initiated
June 09, 2020
Classification
Class II
Status
Terminated
Recalling firm
EHOB, Inc.
Quantity
173

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
QC inspection observed that a portion of the lot may have been contaminated with blood.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

QC inspection observed that a portion of the lot may have been contaminated with blood.

Code information

Lot 93649FA

Distribution pattern

US Nationwide distribution.