U.S. Food and Drug Administration Issues Product Recall Alert on Manual Resuscitator Devices

The Office of Developmental Programs (ODP) has shared an important announcement from the US Food and Drug Administration (FDA).

Manual Resuscitator Recall: SunMed Holdings, LLC Removes Adult Manual Resuscitator Devices Due to Incorrect Assembly of B/V Filter

SunMed Holdings, LLC is recalling this product due to a manufacturing issue where the B/V filter was assembled onto the patient port instead of the exhalation port. This incorrect configuration may result in a delay in therapy during emergency use.

The use of the 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.

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 the response form via email as soon as possible.
• If you need urgent assistance or replacement, contact SunMed directly.
• Notify all affected personnel in your organization of recall.

Refer to the FDA Original Press Release for instructions on requesting a replacement and additional information.