The Class I recall involves devices with incorrectly assembled B/V filters.

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

The use of the affected product may cause serious adverse health consequences, including lack of oxygen to the body, build-up of carbon dioxide in the blood, organ failure, and death. There have been no reported injuries or deaths.  

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.

This recall involves removing certain devices from where they are used or sold. The US Food and Drug Administration has identified this recall as Class I, the most serious type.

What to Do

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.

The names of the affected product are Adult Manual Resuscitator with Medium Adult Mask, Bag Reservoir, Filter, Manometer, and 7 ft Oxygen Tubing

  • Unique Device Identifier/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  

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

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