CLASS I ONGOING Device recall · Reported 11 Jun 2025 · FDA Enforcement Report
Adult Manual Resuscitator with Medium Adult Mask recalled
SunMed Holdings is recalling Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7, distributed nationwide in the US. The recall was initiated on 1 May 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1814-2025
- FDA event ID
- 96801
- Recalling firm
- SunMed Holdings, Grand Rapids, MI
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 1 May 2025
- FDA classified
- 30 May 2025
- Reported
- 11 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Masks, Gloves & PPE
Timeline
| 1 May 2025 | Recall initiated by company | |
| 30 May 2025 | Classified by FDA | +29 days |
| 11 Jun 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F
Where it was distributed
US Nationwide distribution via Medline.
Questions about this recall
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.
Which lots are affected?
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
Where was it sold?
US Nationwide distribution via Medline.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from SunMed Holdings
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|---|---|---|---|---|---|
| Device | CLASS I | Broselow Pediatric Emergency Rainbow Tape recalled by SunMed Holdings | SunMed Holdings | Device Malfunction | Nationwide |
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| Device | CLASS I | Broselow Domestic Complete ALS Organizer recalled by SunMed Holdings | SunMed Holdings | Device Malfunction | Nationwide |
| Device | CLASS I | Broselow Pediatric Emergency Rainbow Tape recalled by SunMed Holdings | SunMed Holdings | Device Malfunction | Nationwide |
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Other Masks, Gloves & PPE recalls
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|---|---|---|---|---|---|
| Device | CLASS II | P28 Phanton Intramedullary Nail System recalled by Paragon 28 | Paragon 28 | Sterility | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray | Device Malfunction | Nationwide |
| Device | CLASS II | Adapter for Head Positioning recalled by Baxter Healthcare | Baxter Healthcare | Other | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray | Device Malfunction | Nationwide |
| Device | CLASS II | Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference recalled | O&M Halyard | Other | Nationwide |