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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95303

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

Open FDA event record

Event summary

Timeline bucket
August 30, 2024
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Mercury Enterprises, Inc. dba Mercury Medical

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

Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.

Z-0004-2025
Recall number
Z-0004-2025
Initiated
August 30, 2024
Classification
Class I
Status
Ongoing
Quantity
1,300 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.

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

Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.

Code information

Part Number: 1050805; UDI/DI: 10641043508053, 30641043508057; Lot Numbers: 2417650805, 2417750805. Part Number: 1050832; UDI/DI: 10641043508329, 30641043508323; Lot Numbers: 2423550832, 2417850832.

Distribution pattern

US distribution to MI, FL, SC, PA, IN. International distribution to Albania.