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Use caution Medical device recall · FDA · Published May 8, 2018

Vyaire AirLife Resuscitation Device: Airflow obstruction risk during use

Vyaire Medical recalls AirLife Resuscitation Devices with potential airflow obstruction during oxygen delivery. Affected models include specific part numbers and lot numbers for adult use. Consumers should check their device details to determine if recalled.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2552-2018Medical deviceVyaire Medical ›
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Contact the company

Recalling firmVyaire Medical26125 N Riverwoods Blvd · Mettawa, IL 60045-3420
✎ GovInfoNow plain-language explainer

Vyaire Medical is recalling AirLife Resuscitation Devices that may obstruct oxygen flow during use. This could lead to inadequate breathing support for patients in emergency situations. Read more at govinfonow.com/recall/71164-vyaire-airlife-resuscitation-device-airflow-obstruction-risk-during-use.

Source Summary by GovInfoNow · govinfonow.com/recall/71164-vyaire-airlife-resuscitation-device-airflow-obstruction-risk-during-use · Updated August 21, 2026 · FDA enforcement record: FDA #Z-2552-2018

Cite this page

“Vyaire AirLife Resuscitation Device: Airflow obstruction risk during use.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71164-vyaire-airlife-resuscitation-device-airflow-obstruction-risk-during-use. Based on FDA recall #Z-2552-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2552-2018%22&limit=1).

The FDA announced on May 8, 2018, that Vyaire Medical voluntarily recalled AirLife Resuscitation Devices due to a manufacturing error that may obstruct supplemental oxygen airflow. The recall affects 15,714 units distributed in the United States.

How to tell if you have it

  • Brand: Vyaire Medical
  • Product: AirLife Resuscitation Device, Adult
  • Part Number 2K8004 with Lot Numbers 0001209844, 0001207350, 0001207351, 0001207352, 0001207353
  • Part Number 2K8035C2 with Lot Number 0001209833
  • Part Number 2K8017 with Lot Numbers 0004003362, 0004003363, 0001209835, 0001209836
  • Part Number 2K8005 with Lot Numbers 0001207345, 0001207346, 0001207347, 0001207349, 0001209842, 0001209843
  • Part Number 2K8036 with Lot Numbers 0001207354, 0001210191, 0001210192
  • Part Number 2K8001 with Lot Number 0001209841
  • Part Number 2K8035M with Lot Number 001209834
  • Part Number 2K8004C2 with Lot Number 0001209847

The hazard

According to the FDA, a manufacturing error in the AirLife Resuscitation Devices has the potential to obstruct airflow of the supplemental oxygen delivery during use. The devices are manual resuscitators intended for single patient use to provide positive pressure ventilation.

Context

GovInfoNow's records show Vyaire Medical has 9 other recalls on record since July 18, 2017. Other recent recalls of similar products include AirLife Infant Heated Wire Circuit Recall (April 10, 2025), Vyaire AirLife Resuscitator Recall (Jan. 10, 2024), and Vyaire Flexible Patient Circuit 3100A (Oct. 27, 2023). Other recent recalls of similar products include Medline Oxygen Masks Recall (Nov. 21, 2025), Ventec V+Pro Ventilator Recall (March 25, 2026), and Hamilton Medical Breathing Circuit Sets Risk (May 29, 2026).

How to tell if you have this one

Check the device label for part numbers: 2K8004, 2K8035C2, 2K8017, 2K8005, 2K8036, 2K8001, 2K8035M, or 2K8004C2. Also look for lot numbers listed in the recall notice for each part number.

  • Brand
    Vyaire Medical
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class I
  • Status
    Terminated
  • Distribution
    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.
Recall numberProduct, codes & lots
Z-2552-2018AirLife 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.; 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;
Z-2553-2018AirLife 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.; 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
Based on the official FDA remedy

What to do — step by step

  1. Check Device Label

    Look for part numbers on the device label to see if they match the recalled models listed in the notice.

  2. Contact Manufacturer

    If you have a recalled device, contact Vyaire Medical directly for further instructions.

Where it went and when

Where it was distributed

Distributed in 27 states and Puerto Rico.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: yesWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: yesILWisconsin: not listedWIMichigan: yesMINew York: yesNYRhode Island: not listedRIMassachusetts: yesMAOregon: yesORNevada: not listedNVWyoming: not listedWYSouth Dakota: yesSDIowa: yesIAIndiana: not listedINOhio: yesOHPennsylvania: not listedPANew Jersey: yesNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: yesCONebraska: not listedNEMissouri: yesMOKentucky: yesKYWest Virginia: not listedWVVirginia: yesVAMaryland: yesMDDelaware: not listedDEArizona: yesAZNew Mexico: not listedNMKansas: not listedKSArkansas: yesARTennessee: not listedTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFLPuerto Rico: yesPR

FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Illinois, Iowa, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, New Jersey, New York, North Carolina, Ohio, Oregon, Puerto Rico, South Dakota, Texas, Virginia, Washington.

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

1. Firm started the recall: May 8, 201812. FDA classified it Class I: Aug 8, 201823. Published in FDA’s Enforcement Report: Aug 15, 201834. FDA terminated the recall: Jul 7, 2020420182020
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using the device immediately?

The recall does not require immediate discontinuation; however, you should check if your device is affected before use.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2552-2018 (May 8, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2552-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA