FDA Medical devices recall ·
Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1814-2025
- Date
- (initiated May 1, 2025)
- Company / brand
- SunMed Holdings, LLC
2710 Northridge Dr Nw Ste A, Grand Rapids, MI, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 11,358
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
US Nationwide distribution via Medline.
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-1814-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.