CLASS II Device recall · Reported 20 Jun 2018 · FDA Enforcement Report
Medline Adult Manual Resuscitator With Medium Adult Mask recalled
Sun Med is recalling Medline Adult Manual Resuscitator With Medium Adult Mask, Tube Reservoir And 7 Ft, 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-2152-2018
- 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
- Masks, Gloves & PPE
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
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1126
Where it was distributed
IL & OH distributors
Questions about this recall
Is Medline Adult Manual Resuscitator With Medium Adult Mask, Tube Reservoir And 7 Ft recalled?
Yes. Sun Med recalled Medline Adult Manual Resuscitator With Medium Adult Mask, Tube Reservoir And 7 Ft on 24 May 2018. The recall is Class II and its status is Terminated. Recall number Z-2152-2018.
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: 313546, 313717, 313176 & 313772
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 21 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 Sun Med
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Stat-Check Manual Resuscitator / Ventilator recalled by Sun Med | 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 |
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