Class IIOngoingZ-1889-2025
Mozarc Medical US LLC recalls MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Potential breach of sterile barrier packaging.
Mozarc Medical US LLCMAJun 11, 2025
Recalls in Massachusetts
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 325–336 of 426 recalls
Class IIOngoingZ-1888-2025
Mozarc Medical US LLC recalls Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane ca…
Potential breach of sterile barrier packaging.
Mozarc Medical US LLCMAJun 11, 2025
Class IIOngoingZ-1887-2025
Mozarc Medical US LLC recalls Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane c…
Potential breach of sterile barrier packaging.
Mozarc Medical US LLCMAJun 11, 2025
Class IIOngoingZ-1886-2025
Mozarc Medical US LLC recalls Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane…
Potential breach of sterile barrier packaging.
Mozarc Medical US LLCMAJun 11, 2025
Class IIOngoingZ-1885-2025
Mozarc Medical US LLC recalls Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane cath…
Potential breach of sterile barrier packaging.
Mozarc Medical US LLCMAJun 11, 2025
Class IIOngoingZ-1864-2025
NxStage Medical Inc recalls NxStage PureFlow-B Solution. Catalog numbers: RFP-400
Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the electrolyte fluid to splash into the face of the user when attempting to open the peel seam to mix the two chambers prior t…
NxStage Medical IncMAJun 4, 2025
Class IIOngoingZ-1863-2025
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
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
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