Z-1059-2024Class I

AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F

Name: Z-1059-2024 AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F
Creator: Vyaire Medical
Published: 2024-01-10
License: https://open.fda.gov/license/

Jaeger Medical GmbH / initiated 2024-01-10 / Open, Classified / root cause: manufacturing process

FDA source

Vyaire Medical began a recall of AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F on 2024-01-10. FDA classified it as Class I and gives the reason as "Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1059-2024
Classification: Class I
Status: Open, Classified
Initiated: 2024-01-10
Posted: 2024-02-25
Recalling firm: Jaeger Medical GmbH
Product: AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F
Product code: BTM Ventilator, Emergency, Manual (Resuscitator)
Reason for recall: Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Vyaire issued an URGENT: Customer notification Letter to its consignees on 01/10/2024 via letter delivered by UPS Next Day Air. The notice explained the problem, complaints received, and requested the consignee discard or destroy all affected devices. If the consignee further distributed the product, they were directed to forward a copy of the notice to those parties.
Quantity in commerce: 8,220 units
Distribution: Worldwide distribution. US nationwide, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa
Product codes and lots: UDI/DI Case: 50190752114133, Each: 10190752114135; All manufacturing dates of 2017 and prior, and any products without a manufacturing date.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1059-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1057-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-24
Z-1058-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-24
Z-1059-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-24
Z-1060-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-24
Z-1061-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-24
Z-1062-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-24
Z-1063-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-24
Z-1064-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-24
Z-1065-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-24

Product code BTM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)