Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxyge...

FDA Device Recall #Z-1814-2025 - Class I, May 1, 2025

Recall Summary

Recall Number Z-1814-2025
Classification Class I - Serious risk
Date Initiated May 1, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm SunMed Holdings, LLC
Location Grand Rapids, MI
Product Type Devices
Quantity 11,358

Product Description

Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F

Reason for Recall

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.

Distribution Pattern

US Nationwide distribution via Medline.

Lot / Code Information

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

Other Recalls from SunMed Holdings, LLC

Recall # Classification Product Date
Z-1117-2026 Class I Brand Name: Broselow Product Name: BROSELOW" F... Dec 15, 2025
Z-1115-2026 Class I Brand Name: Broselow Product Name: Broselow Pe... Dec 15, 2025
Z-1116-2026 Class I Brand Name: Broselow Product Name: Broselow Do... Dec 15, 2025
Z-1114-2026 Class I Brand Name: Broselow Product Name: Broselow Pe... Dec 15, 2025
Z-1904-2025 Class I Broselow Pediatric Emergency Rainbow Tape (dist... May 15, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.