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
Recalls in Massachusetts
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 169–180 of 371 recalls
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
Class IIOngoingZ-0491-2026
Siemens Healthcare Diagnostics, Inc. recalls IMMULITE 2000 Oak Mix 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-0480-2026
NeuroLogica Corporation recalls GM85 Digital Mobile X-ray imaging System
The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue.
NeuroLogica Corporatio…MANov 19, 2025
Class IIOngoingZ-0479-2026
Miach Orthopaedics recalls BEAR Implant (Bridge-Enhanced ACL Restoration)
The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.
Miach OrthopaedicsMANov 19, 2025
Class IIOngoingZ-0426-2026
Mozarc Medical US LLC recalls MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Sa…
A potential issue with the seal integrity of header bag packaging.
Mozarc Medical US LLCMANov 12, 2025
Class IIOngoingZ-0425-2026
Mozarc Medical US LLC recalls MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Co…
A potential issue with the seal integrity of header bag packaging.
Mozarc Medical US LLCMANov 12, 2025
Class IIOngoingZ-0424-2026
Mozarc Medical US LLC recalls MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Co…
A potential issue with the seal integrity of header bag packaging.
Mozarc Medical US LLCMANov 12, 2025
Class IIOngoingZ-0423-2026
Mozarc Medical US LLC recalls MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Comp…
A potential issue with the seal integrity of header bag packaging.
Mozarc Medical US LLCMANov 12, 2025