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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94544

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

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Event summary

Timeline bucket
May 08, 2024
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Megadyne Medical Products, 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

MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-50lb), (350g-22.7Kg), 66cm Long x 30.5cm Wide x 1.25cm. Electrosurgical use.

Z-1920-2024
Recall number
Z-1920-2024
Initiated
May 08, 2024
Classification
Class I
Status
Ongoing
Quantity
1270

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reports of patient burns.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of patient burns.

Code information

Model Number: 0840; UDI-DI: 10614559103395; Lot Number: All distributed lot numbers.

Distribution pattern

Worldwide distribution. US nationwide including Puerto Rico; Australia, Austria, Bahrain, Belgium, Canada, Chile, Czechia, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Japan, the Netherlands, Norway, Poland, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Switzerland, Thailand, United Arab Emirates, and United Kingdom.