This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Affected Product

Product Names: Adult Manual Resuscitator with Medium Adult Mask, Bag Reservoir, Filter, Manometer and 7 ft Oxygen Tubing
Unique Device Identifier (UDI)/Model: Each: 10884389164822, Case: 40884389164823
Lot/Serial Numbers: 526782, 526790, 526796, 526797, 526798, 526800, 526802, 526804, 526805, 526806, 26807, 526808, 526809, 526810, 526814, 526815, 526816, 526811, 526817, 526818

What to Do

Stop using and quarantine all affected product immediately.
Document quantity on hand and arrange to return or destroy affected units.

On May 1, 2025, SunMed Holdings, LLC sent all affected customers an Urgent Medical Device Recall notice recommending the following actions:

Check your inventory for the affected product.
Stop using the product immediately and quarantine it.
Document the amount of product on hand and return or destroy affected units.
Distribute the recall notice to any customers who received the product from you.
Complete and return response form via e-mail to [email protected] as soon as possible.
If you need urgent assistance or replacement, contact SunMed directly.
Notify all affected personnel in your organization of recall.

Reason for Recall

SunMed Holdings, LLC is recalling Adult Manual Resuscitator devices due to incorrect assembly of the B/V filter.

The use of affected product may cause serious adverse health consequences, including lack of oxygen to the body (hypoxia), build-up of carbon dioxide in the blood (hypercapnia), organ failure, and death.

There have been no reported injuries. There have been no reports of death.

Device Use

The manual resuscitator is used to provide emergency respiratory support to adult patients. It includes a face mask, bag reservoir, filter, manometer, and oxygen tubing, and is used during situations such as cardiac arrest or respiratory failure to manually deliver breaths.

Contact Information

Customers in the U.S. with questions about this recall should contact SunMed Holdings, LLC at 1-800-433-2797.

Additional FDA Resources (listed in order of most to least recent):

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.