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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80500

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

Open FDA event record

Event summary

Timeline bucket
May 08, 2018
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Vyaire 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

2 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 2

AirLife Resuscitation Device, Adult labeled as the following: a. Adult, with mask, oxygen reservoir bag, Part Number 2K8004; b. Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP valve, Part Number 2K8035C2; c. Adult, with mask, 28" large bore tubing, Part Number 2K8017; d. Adult, with mask, 40" oxygen reservoir tubing, Part Number 2K8005; e. Adult, with mask, 40" oxygen reservoir tubing, PEEP valve, Part Number 2K8036; f. Adult, without mask, 40" oxygen reservoir tubing, Part Number 2K8001; g. Adult, with mask, oxygen reservoir bag, manometer, PEEP valve, Part Number 2K8035M; h. Adult, with mask, oxygen reservoir bag, CO2 detector, Part Number 2K8004C2; Manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own. The devices are intended for use as single patient use resuscitator devices for pulmonary resuscitation.

Z-2552-2018
Recall number
Z-2552-2018
Initiated
May 08, 2018
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
15,714 units total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
error in manufacturing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of the supplemental oxygen delivery during use.

Code information

a. Part Number 2K8004, Lot Numbers 0001209844, 0001207350, 0001207351, 0001207352, 0001207353; b. Part Number 2K8035C2, Lot Numbers 0001209833; c. Part Number 2K8017, Lot Numbers 0004003362, 0004003363, 0001209835, 0001209836; d. Part Number 2K8005, Lot Numbers 0001207345, 0001207346, 0001207347, 0001207349, 0001209842, 0001209843; e. Part Number 2K8036, Lot Numbers 0001207354, 0001210191, 0001210192; f. Part Number 2K8001, Lot Numbers 0001209841; g. Part Number 2K8035M, Lot Numbers 001209834; h. Part Number 2K8004C2, Lot Numbers 0001209847;

Distribution pattern

US distribution only to: AL, AR, AZ, CA, CA, CO, FL, GA, HI, IA, IL, KY, LA, MA, MD, MI, MN, MO, MS, NC,NJ, NY, OH, OR, PR, SD, TX, VA, WA.

device · product 2 of 2

AirLife Resuscitation Device, Pediatric labeled as the following: a. Pediatric, with mask, 28" large bore tubing, pressure-relief valve, Part Number 2K8018; b. Pediatric, with mask, 40" oxygen reservoir bag, pressure-relief valve, Part Number 2K8008; c. Pediatric, Resuscitation kit with neonatal, infant and pediatric masks, Part Number RE1DK5445D; d. Pediatric, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve, Part Number 2K8039 Manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own. The devices are intended for use as single patient use resuscitator devices for pulmonary resuscitation.

Z-2553-2018
Recall number
Z-2553-2018
Initiated
May 08, 2018
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
15,714 units total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
error in manufacturing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of the supplemental oxygen delivery during use.

Code information

a. Part Number 2K8018, Lot Number 0001210201; b. Part Number 2K8008 Lot Numbers 0001209831, 0001209837; c. Part Number RE1DK5445D, Lot Numbers 0004002563, 0004003205; d. Part Number 2K8039, Lot Number 0001209839

Distribution pattern

US distribution only to: AL, AR, AZ, CA, CA, CO, FL, GA, HI, IA, IL, KY, LA, MA, MD, MI, MN, MO, MS, NC,NJ, NY, OH, OR, PR, SD, TX, VA, WA.