Draeger Medical, Inc. NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L) Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)
Brand
Draeger Medical, Inc.
Lot Codes / Batch Numbers
All Lot numbers. UDI-DI: 04048675040552 (MP01579), 04048675040569 (MP01580), 04048675040538 (MP01581)
Products Sold
All Lot numbers. UDI-DI: 04048675040552 (MP01579); 04048675040569 (MP01580); 04048675040538 (MP01581)
Draeger Medical, Inc. is recalling NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01 due to The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic im. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.
Recommended Action
Per FDA guidance
An Urgent Medical Device Correction notification letter dated January 2023 was sent to customers. Actions to be taken: Use of the mask is contraindicated for patients and other persons in close vicinity to patients using the masks, that have implanted devices that may be affected by magnets, including but not limited to: Pacemakers Implantable cardioverter defibrillators (ICD) Neurostimulators Magnetic metallic implants/electrodes/valves placed in upper limbs, torso, or higher (i.e., neck and head) Cerebral spinal fluid (CSF) shunts (e.g., ventriculoperitoneal (VP) shunt) Aneurysm clips Embolic coils Intracranial aneurysm intravascular flow disruption devices Metallic cranial plates, screws, burr hole covers, and bone substitute devices Metallic splinters in the eye Ocular implants (e.g., glaucoma implants, retinal implants) Certain contact lenses with metal Implants to restore hearing or balance that have an implanted magnet (such as cochlear implants, implanted bone conduction hearing devices, and auditory brainstem implants) Magnetic denture attachments Metallic gastrointestinal clips Metallic stents (e.g., aneurysm, coronary, tracheobronchial, biliary) Implantable ports and pumps (e.g., insulin pumps) Hypoglossal nerve stimulators Devices labeled as MR (Magnetic Resonance) unsafe Magnetic metallic implants not labeled for MR or not evaluated for safety in a magnetic field Apart from the contraindication, you can continue to use NovaStar masks, if you ensure that the magnets are kept at least 15 cm (approx. 6 inches) away from any other medical implants or medical devices that can be impacted by the magnetic fields. According to our records, your facility has received NovaStar TS masks material number MP01576, MP01577, MP01578, MP01579, MP01580, and/or MP01581, manufactured by Draegerwerk AG & Co. KGaA. Please add a copy of this Urgent Medical Device Correction Notification to every box of masks you have in your facilit
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026