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# FDA MedWatch - Ventlab Resuscitator Bags: Recall - Possible Health Risk
- URL: https://www.foodconsumer.org/ventlab_resuscitator_bags_0516141107/
- Published: 2014-05-17T00:07:00.000Z
- Updated: 2026-09-22T16:31:33.000Z
- Description: Ventlab is removing certain resuscitator bags from the market after complaints that a sticking duckbill valve left the bag delivering no air to the patient. The failure can delay treatment and cause hypoxia; users should stop using affected lots and contact the company.
- Author: Food Consumer
- Tags: Miscellaneous, Health News, #vivvo-import

**AUDIENCE**: Risk Manager, Emergency Medicine, Anesthesiology

**ISSUE**: Ventlab, LLC. initiated a voluntary medical device removal of certain Ventlab Resuscitator Bags after becoming aware of complaints regarding a sticking duckbill valve that resulted in the resuscitation bags delivering no air through the patient valve, to the patient. Resuscitation bags affected may not function properly and may result in a delay of treatment and life threatening health consequences that include hypoxia and hypoventilation. 

**BACKGROUND**: Please refer to the [firm's press release](http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTQwNTE2LjMyMjc0NDMxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE0MDUxNi4zMjI3NDQzMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE2ODMyOTgyJmVtYWlsaWQ9Zm9vZGNvbnN1bWVyLm9yZ0BnbWFpbC5jb20mdXNlcmlkPWZvb2Rjb25zdW1lci5vcmdAZ21haWwuY29tJmZsPSZleHRyYT1NdWx0aXZhcmlhdGVJZD0mJiY=&&&100&&&http://www.fda.gov/Safety/Recalls/ucm397682.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) for a list of recalled models.

**RECOMMENDATION**: Users who have resuscitation bags within the lot numbers listed in the [firm's press release](http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTQwNTE2LjMyMjc0NDMxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE0MDUxNi4zMjI3NDQzMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE2ODMyOTgyJmVtYWlsaWQ9Zm9vZGNvbnN1bWVyLm9yZ0BnbWFpbC5jb20mdXNlcmlkPWZvb2Rjb25zdW1lci5vcmdAZ21haWwuY29tJmZsPSZleHRyYT1NdWx0aXZhcmlhdGVJZD0mJiY=&&&101&&&http://www.fda.gov/Safety/Recalls/ucm397682.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) should stop using them and immediately contact Ventlab, LLC. for further instructions on the return of these products.

Ventlab, LLC. will notify its distributors and customers by a direct mailing and arrange for the return and replacement of all of the recalled resuscitation bags. Users with questions may contact Ventlab LLC. via telephone at [1-844-635-5326](tel:1-844-635-5326) between the hours of 8:30 AM to 5:00 PM (EST) Monday through Friday. Consumers may also contact the company via e-mail at[PFA@ventlab.com](mailto:PFA@ventlab.com).

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

- Complete and submit the report Online:[www.fda.gov/MedWatch/report.htm](http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTQwNTE2LjMyMjc0NDMxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE0MDUxNi4zMjI3NDQzMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE2ODMyOTgyJmVtYWlsaWQ9Zm9vZGNvbnN1bWVyLm9yZ0BnbWFpbC5jb20mdXNlcmlkPWZvb2Rjb25zdW1lci5vcmdAZ21haWwuY29tJmZsPSZleHRyYT1NdWx0aXZhcmlhdGVJZD0mJiY=&&&102&&&http://www.fda.gov/MedWatch/report.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)
- [Download form](http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTQwNTE2LjMyMjc0NDMxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE0MDUxNi4zMjI3NDQzMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE2ODMyOTgyJmVtYWlsaWQ9Zm9vZGNvbnN1bWVyLm9yZ0BnbWFpbC5jb20mdXNlcmlkPWZvb2Rjb25zdW1lci5vcmdAZ21haWwuY29tJmZsPSZleHRyYT1NdWx0aXZhcmlhdGVJZD0mJiY=&&&103&&&http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) or call [1-800-332-1088](tel:1-800-332-1088) to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including links to the Press Release at: [http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm397749.htm](http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTQwNTE2LjMyMjc0NDMxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE0MDUxNi4zMjI3NDQzMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE2ODMyOTgyJmVtYWlsaWQ9Zm9vZGNvbnN1bWVyLm9yZ0BnbWFpbC5jb20mdXNlcmlkPWZvb2Rjb25zdW1lci5vcmdAZ21haWwuY29tJmZsPSZleHRyYT1NdWx0aXZhcmlhdGVJZD0mJiY=&&&104&&&http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm397749.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)

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