Class IIOngoingZ-1862-2025
Straumann USA LLC recalls GM Helix Acqua Implant
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
Straumann USA LLCMAJun 4, 2025
Recalls in Massachusetts
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 277–288 of 371 recalls
Class IIOngoingZ-1861-2025
Straumann USA LLC recalls Plus Initial Drill
The referred batch was produced without the laser engraving of 7 mm.
Straumann USA LLCMAJun 4, 2025
Class IIOngoingZ-1822-2025
Siemens Healthcare Diagnostics, Inc. recalls ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.
Siemens Healthcare Dia…MAJun 4, 2025
Class IIOngoingZ-1821-2025
Siemens Healthcare Diagnostics, Inc. recalls Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.
Siemens Healthcare Dia…MAJun 4, 2025
Class IIOngoingZ-1805-2025
Philips North America LLC recalls Product Name: MR 7700
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Philips North America…MAMay 28, 2025
Class IIOngoingZ-1804-2025
Philips North America LLC recalls Product Name: MR 5300
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Philips North America…MAMay 28, 2025
Class IIOngoingZ-1803-2025
Philips North America LLC recalls Product Name: Ingenia Elition X
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Philips North America…MAMay 28, 2025
Class IIOngoingZ-1802-2025
Philips North America LLC recalls Product Name: Ingenia Elition S
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Philips North America…MAMay 28, 2025
Class IIOngoingZ-1801-2025
Philips North America LLC recalls Product Name: Ingenia Ambition X
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Philips North America…MAMay 28, 2025
Class IIOngoingZ-1800-2025
Philips North America LLC recalls Product Name: Ingenia 3.0T CX
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Philips North America…MAMay 28, 2025
Class IIOngoingZ-1799-2025
Philips North America LLC recalls Product Name: Ingenia 1.5T CX
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Philips North America…MAMay 28, 2025
Class IIOngoingZ-1798-2025
Philips North America LLC recalls Product Name: Ingenia Ambition S
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Philips North America…MAMay 28, 2025