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# SunMed Manual Resuscitators Recalled
- URL: https://www.fdaweb.com/sunmed-manual-resuscitators-recalled/
- Published: 2025-07-18T12:00:00.000Z
- Updated: 2026-09-14T15:17:00.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159532

SunMed Holdings is recalling (Class 1) its Adult Manual Resuscitator devices due to incorrect assembly of the bacterial/viral 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,” a [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls/manual-resuscitator-recall-sunmed-holdings-llc-removes-adult-manual-resuscitator-devices-due?utm%5Fmedium=email&utm%5Fsource=govdelivery) says. To date, the company says there have been no reported injuries.

The device 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 deliver breaths manually.