Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
22,877medical device recall records
2,186FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.736 records
Database records
Records — page 282
22,877 detailed records are currently available in this category.
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous…
Class IIFDA: OngoingOrtho-Clinical Diagnostics, Inc.
Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS 3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems which may lead…
Class IIFDA: OngoingOrtho-Clinical Diagnostics, Inc.
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined,…
Class IIFDA: OngoingOrtho-Clinical Diagnostics, Inc.
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous…
Class IIFDA: OngoingOrtho-Clinical Diagnostics, Inc.
For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG…
Class IIFDA: OngoingCanon Medical System, USA, Inc.
Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
Class IIFDA: OngoingFUJIFILM Healthcare Americas Corporation
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined,…
Class IIFDA: OngoingOrtho-Clinical Diagnostics, Inc.
Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
Class IIFDA: OngoingFUJIFILM Healthcare Americas Corporation
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined,…
Class IIFDA: OngoingOrtho-Clinical Diagnostics, Inc.
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous…
Class IIFDA: OngoingOrtho-Clinical Diagnostics, Inc.
The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the…
Class IIFDA: OngoingWaldemar Link GmbH & Co. KG (Mfg Site)
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined,…
Class IIFDA: OngoingOrtho-Clinical Diagnostics, Inc.
For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG…
Class IIFDA: OngoingCanon Medical System, USA, Inc.
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined,…
Class IIFDA: OngoingOrtho-Clinical Diagnostics, Inc.
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for…
Class IFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
How to use this medical device recall index
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
What the database can and cannot tell you
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.