Class IIOngoingZ-0852-2026
Philips North America LLC recalls IntelliVue MP30. Product Number: M8002A.
Potential issue where the IntelliVue monitors did not alarm.
Philips North America…MADec 10, 2025
Recalls in Massachusetts
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 217–228 of 426 recalls
Class IIOngoingZ-0851-2026
Philips North America LLC recalls IntelliVue MP20. Product Number: M8001A.
Potential issue where the IntelliVue monitors did not alarm.
Philips North America…MADec 10, 2025
Class IIOngoingZ-0850-2026
Philips North America LLC recalls IntelliVue MP5. Product Number: M8105A.
Potential issue where the IntelliVue monitors did not alarm.
Philips North America…MADec 10, 2025
Class IIOngoingZ-0849-2026
Philips North America LLC recalls IntelliVue MP2. Product Number: M8102A.
Potential issue where the IntelliVue monitors did not alarm.
Philips North America…MADec 10, 2025
Class IIOngoingZ-0848-2026
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS)
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
Fresenius Kabi USA, LL…MADec 10, 2025
Class IOngoingZ-0586-2026
Fresenius Kabi USA, LLC recalls IVENIX INFUSION SYSTEM
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Fresenius Kabi USA, LL…MADec 10, 2025
Class IIOngoingZ-0584-2026
Magellan Diagnostics, Inc. recalls The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor…
Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for lot 2333M. The use of mislabeled calibration Button with Lot #2333 can lead to delayed or erroneous high or erroneous low re…
Magellan Diagnostics,…MADec 3, 2025
Class IIOngoingZ-0582-2026
Straumann USA LLC recalls Emdogain
The possibility for this product that is intended for demonstration purposes only to be placed in patients.
Straumann USA LLCMADec 3, 2025
Class IIOngoingZ-0578-2026
Foundation Medicine, Inc. recalls FoundationOne Liquid CDx (F1LCDx)
Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.
- Somatic Or Germline Variant Detection System Next Generation Sequencing Oncology Panel
- Under Investigation by firm
Foundation Medicine, I…MADec 3, 2025
Class IIOngoingZ-0577-2026
Foundation Medicine, Inc. recalls FoundationOne CDx (F1CDx)
Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.
- Somatic Or Germline Variant Detection System Next Generation Sequencing Oncology Panel
- Under Investigation by firm
Foundation Medicine, I…MADec 3, 2025
Class IIOngoingZ-0493-2026
Siemens Healthcare Diagnostics, Inc. recalls Food Panel 3 Specific Allergen
The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanne…
Siemens Healthcare Dia…MANov 19, 2025
Class IIOngoingZ-0492-2026
Siemens Healthcare Diagnostics, Inc. recalls 3gAllergy Specific IgE Universal Kit
The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanne…
Siemens Healthcare Dia…MANov 19, 2025