Adult Manual Resuscitator (SunMed) – Filter Port Misplacement (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F
Brand
SunMed Holdings, LLC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
UDI-DI: EA: 10884389164822 CS: 40884389164823 Lots: 526782 526790 526796 526797 526798 526800 526802 526804 526805 526806 526807 526808 526809 526810 526814 526815 526816 526811 526817 526818
SunMed Holdings, LLC is recalling Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen T due to Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed p. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption or delay in patient resuscitation, which may lead to life threatening consequences, including hypoxia, hypercapnia, organ failure, and death.
Recommended Action
Per FDA guidance
Recall initiated May 1, 2025. Customers instructed to immediately cease use of any affected product and quarantine all affected product. Customers were instructed to return or destroy affected product. AirLife will send new replacement product to customers once disposition is confirmed. If you need replacement products to be sent to you urgently, please call AirLife directly on 1-800-433-2797 and the firm will make every effort to accommodate your needs.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026