Class IIOngoingZ-2893-2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
PHILIPS MEDICAL SYSTEM…Aug 12, 2026
Recalls: Under Investigation by firm
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 13–24 of 1,213 recalls
Class IIOngoingZ-2892-2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion under the following System Descriptions and corresponding model numbers…
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
PHILIPS MEDICAL SYSTEM…Aug 12, 2026
Class IIOngoingZ-2891-2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura under the following System Descriptions and corresponding model numbers:…
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
PHILIPS MEDICAL SYSTEM…Aug 12, 2026
Class IIOngoingZ-2890-2026
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Urine Albumin REF: 11537225
Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results;…
Siemens Healthcare Dia…NYAug 12, 2026
Class IIOngoingZ-2887-2026
Hardy Diagnostics recalls HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (F…
Due to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results and may lead to selection of an ineffective antimicrobial therapy, pote…
Hardy DiagnosticsCAAug 12, 2026
Class IIIOngoingZ-2881-2026
Siemens Healthcare Diagnostics, Inc. recalls Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog…
out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2.…
Siemens Healthcare Dia…MAAug 12, 2026
Class IIIOngoingZ-2880-2026
Siemens Healthcare Diagnostics, Inc. recalls Syva Emit Disopyramide Assay Enzyme Immunoassay
Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is l…
Siemens Healthcare Dia…DEAug 12, 2026
Class IIOngoingZ-2877-2026
Biofire Defense recalls FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The…
Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based in vitro diagnostic panel test.
Biofire DefenseUTAug 12, 2026
Class IIOngoingZ-2871-2026
Biomet, Inc. recalls Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Descripti…
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
Biomet, Inc.INAug 12, 2026
Class IIOngoingZ-2870-2026
Biomet, Inc. recalls Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Descripti…
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
Biomet, Inc.INAug 12, 2026
Class IIOngoingZ-2869-2026
Biomet, Inc. recalls Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Descripti…
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
Biomet, Inc.INAug 12, 2026
Class IIOngoingZ-2868-2026
Biomet, Inc. recalls Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Descripti…
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
Biomet, Inc.INAug 12, 2026