CLASS II Device recall · Reported 20 Jun 2018 · FDA Enforcement Report
Stat-Check Manual Resuscitator / Ventilator recalled by Sun Med
Sun Med is recalling Stat-Check Manual Resuscitator / Ventilator, distributed in Illinois. The recall was initiated on 24 May 2018 and the FDA has classified it as Class II.
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-2145-2018
- FDA event ID
- 80201
- Recalling firm
- Sun Med, Grand Rapids, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 May 2018
- FDA classified
- 9 Jun 2018
- Reported
- 20 Jun 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- CPAP & Ventilators
Timeline
| 24 May 2018 | Recall initiated by company | |
| 9 Jun 2018 | Classified by FDA | +16 days |
| 20 Jun 2018 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
Product as listed by the FDA
STAT-Check MANUAL RESUSCITATOR / VENTILATOR, REF SC9200MBP-1
Where it was distributed
IL & OH distributors
Questions about this recall
Why was it recalled?
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
Which lots are affected?
Lot Numbers: 313406, 313447, 313164, 313165 & 313166
Where was it sold?
IL & OH distributors
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
Other products in this recall event
13 other products · FDA event 80201This product is part of a recall event; the main page for the event is Medline Adult Manual Resuscitator With Large Adult Mask recalled.
More recalls from Sun Med
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Adult Manual Resuscitator With Medium Adult Mask recalled | Sun Med | Other | IL |
| Device | CLASS II | Medline Adult Manual Resuscitator With Medium Adult Mask recalled | Sun Med | Other | IL |
| Device | CLASS II | Medline Adult Manual Resuscitator With Medium Adult Mask recalled | Sun Med | Other | IL |
| Device | CLASS II | Medline Adult Manual Resuscitator With Medium Adult Mask recalled | Sun Med | Other | IL |
| Device | CLASS II | Medline Adult Manual Resuscitator With Medium Adult Mask recalled | Sun Med | Other | IL |
Other CPAP & Ventilators recalls
All 554| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |