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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71256

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 13, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
United Surgical Associates

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

3 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 3

Elastic Ankle Support. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.

Z-1664-2015
Recall number
Z-1664-2015
Initiated
April 13, 2015
Classification
Class II
Status
Terminated
Quantity
1278

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction

Code information

Product #: i-94103 Elastic Ankle Support SM Lot#: AP20140815001 Product #: i-94105 Elastic Ankle Support MD Lot#: AP20140815001 Product #: i-94107 Elastic Ankle Support LG Lot#: AP20140815001

Distribution pattern

Domestic: HI International; None

device · product 2 of 3

Elastic Knee Support. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.

Z-1665-2015
Recall number
Z-1665-2015
Initiated
April 13, 2015
Classification
Class II
Status
Terminated
Quantity
1260

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction

Code information

Product #: i-95103 Elastic Knee Support SM Lot#: AP20140815001 Product#: i-95105 Elastic Knee Support MD Lot#: AP20140815001 Product #: i-95107 Elastic Knee Support LG Lot# AP20140815001

Distribution pattern

Domestic: HI International; None

device · product 3 of 3

Keo Brace, elastic wrist brace for carpal tunnel. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.

Z-1666-2015
Recall number
Z-1666-2015
Initiated
April 13, 2015
Classification
Class II
Status
Terminated
Quantity
756

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction

Code information

Product # i-75100 Lot# AK20140801002

Distribution pattern

Domestic: HI International; None