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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64751

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

Open FDA event record

Event summary

Timeline bucket
September 12, 2011
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Engineered Medical Systems,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

Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate or to enhance breathing abilities of the patient. .

Z-1058-2013
Recall number
Z-1058-2013
Initiated
September 12, 2011
Classification
Class I
Status
Terminated
Quantity
1500pcs, 75cs {20pcs per cases)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.

Code information

REF 8-205508-00 Lot Number: 820550800110419.

Distribution pattern

Distributed in the states of PA, IN, NY, CO, and CA.