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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84897

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

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Event summary

Timeline bucket
January 19, 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

Econocare Plus Overlay Item: 1025EC. Intended to aid in the prevention and treatment of pressure injuries and general comfort - Product Usage: The EHOB WAFFLE Overlay intended use is as first line of defense for pressure injury prevention. The design provides the caregiver a point-of-care solution with the versatility of patient handling and transferring, which encourages ease of use and compliance. The design provides airflow to aid in patient comfort and pressure injury prevention.

Z-1457-2020
Recall number
Z-1457-2020
Initiated
January 19, 2020
Classification
Class II
Status
Terminated
Recalling firm
EHOB, Inc.
Quantity
U.S. (TX)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to a nonconformance of product contamination (human blood) of Econocare Plus Waffle Overlay products with the (master) lot # 932213A that may affect a subset of the lot- controlled product (# 932243A). This nonconformance has the potential to expose the end user to materials deemed to be a health risk. Firm is aware of zero instances of contamination in distributed products that have reached consignees.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

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Inspect official wording and provenance

Reason for recall

Due to a nonconformance of product contamination (human blood) of Econocare Plus Waffle Overlay products with the (master) lot # 932213A that may affect a subset of the lot- controlled product (# 932243A). This nonconformance has the potential to expose the end user to materials deemed to be a health risk. Firm is aware of zero instances of contamination in distributed products that have reached consignees.

Code information

Master Lot # 932213A, Product Lot Code 932243A

Distribution pattern

US Nationwide distribution in the state of TX.