Drager SafeStar 55 Medical Devices Recalled for Possible Filter Occlusion
Draeger Medical is recalling approximately 35,950 Drager SafeStar 55 medical devices due to a manufacturing error that may cause occlusion of the device's filters, potentially preventing proper device function.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is classified FDA Class I, the highest priority medical device recall classification. FDA Class I mandates a minimum severity score of 4 per the rubric. No deaths or reported illnesses have been documented in the source material.
Plain-English summary
Draeger Medical, Inc. is recalling approximately 35,950 Drager SafeStar 55 medical devices (Catalog No. MP01790) due to a manufacturing error that may cause occlusion of the device's filters. This could prevent the device from functioning properly.
The recalled devices have been distributed worldwide and across 23 U.S. states, including Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, North Dakota, Nevada, New York, Ohio, Pennsylvania, Tennessee, Texas, Washington, and West Virginia. The affected lot number is LT2103 (UDI-DI: 04048675026785).
Affected customers and healthcare facilities should contact Draeger Medical, Inc. for information regarding their recalled devices.
The recalled product
- Product
- Drager SafeStar 55, Catalog No. MP01790
- Manufacturer
- Draeger Medical, Inc.
- Category
- Medical Device
- Affected units
- 35,950
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 (2)
- UDI-DI: 04048675026785
- Lot No. LT2103.
Distribution
Related recalls
Same manufacturer · Draeger Medical, Inc.
See all →- SevereDraeger Atlan A300 anesthesia workstation ventilator failure FDA Class I recall
FDA (Devices) · 2024-12-25
- SevereFDA Recalls Draeger Atlan A300XL Anesthesia Workstation for Ventilator Failure
FDA (Devices) · 2024-12-25
- CriticalDraeger Atlan A350 Anesthesia Workstation Piston Ventilator Failure
FDA (Devices) · 2024-11-20
- SevereAnesthesia workstation piston ventilator may fail before or during use
FDA (Devices) · 2024-11-20
- SevereDräger Perseus A500 Anesthesia Workstation Recalled for Unexpected Battery-Power Shutdowns
FDA (Devices) · 2024-04-24
Same hazard · filter occlusion
See all →- HighCareFusion Recalls SmartSite Infusion Sets Due to Unlabeled Filter
FDA (Devices) · 2014-07-16
- ModerateDeVilbiss Disposable Suction Container Filter Recall Due to Fluid Exposure
FDA (Devices) · 2013-10-09
Similar recalls
- HighDraeger Infinity Acute Care System Recall for Alarm Failure
FDA (Devices) · 2017-07-26
- HighSmiths Medical Recalls TranStar Disposable Pressure Transducers Due to Defects
FDA (Devices) · 2024-10-30
- CriticalErgoStar CM 55 airway connectors recalled after cracks formed in the hose
FDA (Devices) · 2025-12-17
- HighColoplast Ureteral Dilators Recalled Due to Sterile Packaging Issue
FDA (Devices) · 2024-04-10
- HighDraeger Fabius MRI Anesthesia Machines recalled due to misrouted oxygen hoses
FDA (Devices) · 2022-01-26
- HighDrager PT 4000 Phototherapy System Recalled for Incorrect Fuse Rating
FDA (Devices) · 2012-07-18