Medline Manual Resuscitators Recalled for Backwards Manometer Leak
Medline manual resuscitators are recalled due to a backwards leak in the integrated manometer that allows CO2 rebreathing. The defect affects multiple models used in respiratory care distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II medical device recall involves a functional defect in a critical respiratory device where no injuries or illnesses have been reported. The defect poses a risk of CO2 rebreathing during emergency resuscitation, qualifying it as a High severity risk-of-harm situation under the recall severity rubric.
Plain-English summary
Medline manual resuscitators with integrated manometers are the subject of a recall by manufacturer SunMed Holdings, LLC. The recall encompasses adult, infant, pediatric, and small adult resuscitator models manufactured from September 21, 2018 to the present. Multiple model variants and accessory configurations are included in this recall.
The recalled devices contain a backwards leak in the integrated manometer of the patient valve that allows carbon dioxide rebreathing. During manual resuscitation, this defect could allow exhaled air containing carbon dioxide to be rebreathed, potentially compromising oxygen delivery during emergency respiratory support.
The affected resuscitators have been distributed nationwide to healthcare facilities and medical providers. Distribution has been confirmed across multiple states, including Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Minnesota, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, South Carolina, Tennessee, Texas, Utah, Virginia, and West Virginia.
Healthcare facilities and providers with access to these devices should contact SunMed Holdings, LLC or their medical supplier for information regarding this recall and appropriate action to ensure patient safety.
The recalled product
- Product
- Medline manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Adult Resuscitator REF #s: CPRM1116FPM, CPRM1116FPM4, CPRM1116M, CPRM1116MC, CPRM1116PM, CPRM1116PMT, CPRM1126FM, CPRM1126FPM, CPRM1126FPWM, CPRM1126M; 2. Infant Resus
- Manufacturer
- SunMed Holdings, LLC
- Hazard
- co2-rebreathing
- hypoxia
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI:10888277628298
- (Case UDI: 20888277698885
- ITEM # CPRM1116FM)
- UDI-DI:10888277667785
- (Case UDI: 20888277667782
- ITEM # CPRM1116FMT)
- UDI-DI:10888277654815
- (Case UDI: 20888277654812
- ITEM # CPRM1116FPM)
- UDI-DI:10193489082685
- (Case UDI: 20193489021544
- ITEM # CPRM1116FPM4)
- UDI-DI:10888277628304
- (Case UDI: 20888277628301
- ITEM # CPRM1116M)
- UDI-DI:10888277698826
- (Case UDI: 20888277698823
- ITEM # CPRM1116MC)
- UDI-DI:10888277628311
- (Case UDI: 20888277628318
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighPhilips Azurion X-Ray Systems Table Movement Control Defect Recall
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27
- HighTangent Single Use Digital Catheter Recalled for Distal Shaft Fractures
FDA (Devices) · 2026-05-27