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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83285

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

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Event summary

Timeline bucket
June 21, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Alto Development Corp

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

A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)- Temporary Pacing Electrode as follows: 021-001 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) 021-010 MYO/Wire Ultra-Flex Monopolar (Org.,2-0) 021-011 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) Used as a connection between temporary cardiac pacing or monitoring equipment and the heart.

Z-2098-2019
Recall number
Z-2098-2019
Initiated
June 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Alto Development Corp
Quantity
351.5 Boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Updated instructions for use: Ultra-Flex MYO/WIRE Monopolar pacing wire looped electrode (M-21 Series) to be consistent between electrode IFU and instructions for M-21 loop.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

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Inspect official wording and provenance

Reason for recall

Updated instructions for use: Ultra-Flex MYO/WIRE Monopolar pacing wire looped electrode (M-21 Series) to be consistent between electrode IFU and instructions for M-21 loop.

Code information

Lots 0715A or later

Distribution pattern

Distribution US Nationwide, Czech Republic, Italy, Israel, and UK.