FDA Medical Device Recalls (openFDA)
Vyaire Medical: AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REF 2K8005C2
- Recall number
- Z-1063-2024
- Recalling firm
- Vyaire Medical
- Product
- AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REF 2K8005C2
- Status
- Open, Classified
- Initiated
- 2024-01-10
- Posted
- 2024-02-25
- Terminated
- not on file
- Reason
- 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
- 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
- 4,572 units
- Distribution
- Worldwide distribution. US nationwide, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa
- Lot, serial or model codes
- UDI/DI Case: 50190752114164, Each: 10190752114166; All manufacturing dates of 2017 and prior, and any products without a manufacturing date.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BTM
- Firm FEI
- 3013421741
- Firm city
- Mettawa
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28