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Medical Device Recalls in the United States

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.

24,725medical device recall records

2,223FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.757 records

Database records

Records — page 535

24,725 detailed records are currently available in this category.

Medical DeviceJan 20, 2021

GE Healthcare Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General recall — FDA Z-0858-2021

GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

Class IIFDA: TerminatedGE Healthcare, LLC

Medical DeviceJan 20, 2021

Roche Molecular Systems The cobas z 480 analyzer including dedicated software for IVD use is recall — FDA Z-0846-2021

Dirty Lens May Cause Invalid or False Positive Results

Class IIFDA: TerminatedRoche Molecular Systems, Inc.

Medical DeviceJan 20, 2021

Fresenius Medical Care Holdings Citrasate Liquid Acid concentrate bottles, Model Number recall — FDA Z-0827-2021

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

Class IIFDA: OngoingFresenius Medical Care Holdings, Inc.

Medical DeviceJan 20, 2021

Fresenius Medical Care Holdings Naturalyte Liquid Acid concentrate drums, Product Code recall — FDA Z-0839-2021

The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously…

Class IIFDA: OngoingFresenius Medical Care Holdings, Inc.

Medical DeviceJan 20, 2021

Baxter Healthcare VERITAS Collagen Matrix - Product Usage: intended for use in recall — FDA Z-0807-2021

VERITAS Collagen Matrix 12x25 cm Patches may have undersized width dimensions.

Class IIFDA: TerminatedBaxter Healthcare Corporation

Medical DeviceJan 20, 2021

Fresenius Medical Care Holdings NaturaLyte Liquid Acid concentrate bottles, Model Number recall — FDA Z-0811-2021

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

Class IIFDA: OngoingFresenius Medical Care Holdings, Inc.

Medical DeviceJan 20, 2021

Siemens Healthcare Diagnostics Atellica IM 1600 Analyzer - In vitro diagnostic testing of recall — FDA Z-0863-2021

Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceJan 20, 2021

Fresenius Medical Care Holdings NaturaLyte Liquid Acid concentrate bottles, Model Number recall — FDA Z-0820-2021

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

Class IIFDA: OngoingFresenius Medical Care Holdings, Inc.

Medical DeviceJan 20, 2021

Fresenius Medical Care Holdings Naturalyte Liquid Acid concentrate bottles, Product Code recall — FDA Z-0833-2021

The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously…

Class IIFDA: OngoingFresenius Medical Care Holdings, Inc.

Medical DeviceJan 20, 2021

Fresenius Medical Care Holdings NaturaLyte Liquid Acid concentrate bottles, Model Number recall — FDA Z-0814-2021

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

Class IIFDA: OngoingFresenius Medical Care Holdings, Inc.

Medical DeviceJan 20, 2021

Philips Emission Computed Tomography System Image Process System - Product Usage: intended recall — FDA Z-0852-2021

A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient.

Class IIFDA: TerminatedPhilips North America, LLC

Medical DeviceJan 20, 2021

Siemens Medical Solutions USA Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid recall — FDA Z-0806-2021

After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support arm becoming dislodged in cases when the monitor support arm is used intensely…

Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.

Medical DeviceJan 20, 2021

Fresenius Medical Care Holdings Citrasate Liquid Acid concentrate drums, Product Code recall — FDA Z-0841-2021

The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously…

Class IIFDA: OngoingFresenius Medical Care Holdings, Inc.

Medical DeviceJan 20, 2021

Boston Scientific Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted recall — FDA Z-0735-2021

Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.

Class IFDA: TerminatedBoston Scientific Corporation

Medical DeviceJan 20, 2021

Fresenius Medical Care Holdings NaturaLyte Liquid Acid concentrate bottles, Model Number recall — FDA Z-0816-2021

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

Class IIFDA: OngoingFresenius Medical Care Holdings, Inc.

Medical DeviceJan 20, 2021

ICU Medical icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for recall — FDA Z-0859-2021

Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceJan 20, 2021

Fresenius Medical Care Holdings NaturaLyte Liquid Acid concentrate bottles, Model Number recall — FDA Z-0819-2021

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

Class IIFDA: OngoingFresenius Medical Care Holdings, Inc.

Medical DeviceJan 20, 2021

Fresenius Medical Care Holdings NaturaLyte Liquid Acid concentrate bottles, Model Number recall — FDA Z-0818-2021

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

Class IIFDA: OngoingFresenius Medical Care Holdings, Inc.

Medical DeviceJan 20, 2021

Ortho Clinical Diagnostics VITROS Chemistry Products TP Slides- IVD measure total protein recall — FDA Z-0844-2021

Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides

Class IIFDA: TerminatedOrtho Clinical Diagnostics Inc.

Medical DeviceJan 20, 2021

Fresenius Medical Care Holdings NaturaLyte Liquid Acid concentrate bottles, Model Number recall — FDA Z-0821-2021

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

Class IIFDA: OngoingFresenius Medical Care Holdings, Inc.

Medical DeviceJan 20, 2021

Fresenius Medical Care Holdings Naturalyte Liquid Acid concentrate bottles, Product Code recall — FDA Z-0837-2021

The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously…

Class IIFDA: OngoingFresenius Medical Care Holdings, Inc.

Medical DeviceJan 20, 2021

visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection of recall — FDA Z-0847-2021

Two issues: 1) 5 Lots were found to have incorrect labeling on the outer box stating that the product is CLIA Waived. 2) 3 Lots contain a kit component that expires prior to the expiration…

Class IIFDA: TerminatedVISBY MEDICAL Inc.

Medical DeviceJan 20, 2021

Fresenius Medical Care Holdings Naturalyte Liquid Acid concentrate bottles, Product Code recall — FDA Z-0831-2021

The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously…

Class IIFDA: OngoingFresenius Medical Care Holdings, Inc.

Medical DeviceJan 20, 2021

Fresenius Medical Care Holdings Naturalyte Liquid Acid concentrate drums, Product Code recall — FDA Z-0840-2021

The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously…

Class IIFDA: OngoingFresenius Medical Care Holdings, Inc.

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.