2,143 recalls tagged with “cpsc regulated”.
Merit Medical Systems recalled 18,897 custom inflation kits on December 4, 2025. The inflation device handle may detach from the syringe during use, posing a risk of injury. Healthcare providers and patients should stop using the device immediately.
Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.
Merit Medical Systems recalled 2,192 units of its Custom Manifold Kit on December 4, 2025. The inflation device handle may detach from the syringe during procedures. This poses a significant risk to patients and healthcare providers.
Inflation device handle may detach from the syringe during procedure.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Potential for incomplete scan due to unstable connection inside of floating sensor.
Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.
McCain Foods USA Inc recalled 21,256 cases of Ore-Ida Tater Tots on December 3, 2025. The recall follows reports of clear hard plastic fragments found in the product. Consumers should not consume the product and should seek refunds or replacements immediately.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Philips North America recalled six MR systems on December 3, 2025. The recall affects devices with software versions R11.1 and R12.1 due to potential stiffness value errors. Healthcare providers must stop using the affected units immediately.