Home › Medical Device Recalls

FDA public records

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.

28,535medical device recall records

2,363FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.784 records

Database records

Records — page 1033

28,535 detailed records are currently available in this category.

Medical DeviceOct 12, 2016

Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, 10341161 recall — FDA Z-2912-2016

Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge

Class IIIFDA: TerminatedSiemens Healthcare Diagnostics Inc.

Medical DeviceOct 12, 2016

Ivoclar Vivadent Zenostar MT Color B2 60ml, art. no. 681056 recall — FDA Z-0027-2017

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin…

Class IIFDA: TerminatedIvoclar Vivadent, Inc.

Medical DeviceOct 12, 2016

Ivoclar Vivadent Zenostar MT Color C1 60ml, art. no. 681059 recall — FDA Z-0030-2017

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin…

Class IIFDA: TerminatedIvoclar Vivadent, Inc.

Medical DeviceOct 12, 2016

Siemens Medical Solutions USA Multix Fusion VA10 Product Usage: The Multix Fusion VA10 recall — FDA Z-0014-2017

Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion systems. There is an unlikely risk that an internal part of the table may detach causing the…

Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.

Medical DeviceOct 12, 2016

RAYSEARCH LABORATORIES AB RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 recall — FDA Z-0038-2017

RaySearch became aware of the problem as it was discovered in cooperation with a customer experimenting with the dose calculation on a phantom. The correction concerns two issues found with…

Class IIFDA: TerminatedRAYSEARCH LABORATORIES AB

Medical DeviceOct 12, 2016

Philips Medical Systems Ingenuity Core 128 Model Number 728323 Product Usage: Computed recall — FDA Z-0011-2017

The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the…

Class IIFDA: TerminatedPhilips Medical Systems

Medical DeviceOct 12, 2016

Siemens Medical Solutions USA YSIO Max Product Usage: The Ysio Max is a radiographic system recall — FDA Z-0015-2017

Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion systems. There is an unlikely risk that an internal part of the table may detach causing the…

Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.

Medical DeviceOct 12, 2016

Ivoclar Vivadent Zenostar MT Color A3 60ml, art. no. 681052 recall — FDA Z-0023-2017

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin…

Class IIFDA: TerminatedIvoclar Vivadent, Inc.

Medical DeviceOct 12, 2016

Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812, 1028322 recall — FDA Z-2913-2016

Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge

Class IIIFDA: TerminatedSiemens Healthcare Diagnostics Inc.

Medical DeviceOct 12, 2016

New Star Lasers VariaBreeze recall — FDA Z-2915-2016

FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these indications.

Class IIFDA: TerminatedNew Star Lasers, Inc.

Medical DeviceOct 12, 2016

Integra Lumbar Drainage Set, REF 910120A, Sterile EO, Rx only, primary packaged in a PVC recall — FDA Z-2910-2016

During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.

Class IIFDA: TerminatedIntegra LifeSciences Corp.

Medical DeviceOct 12, 2016

Ivoclar Vivadent Zenostar MT Color C3 60ml, art. no. 681061 recall — FDA Z-0032-2017

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin…

Class IIFDA: TerminatedIvoclar Vivadent, Inc.

Medical DeviceOct 12, 2016

Randox Laboratories IgE Calibrator Series recall — FDA Z-0050-2017

According to the firm, the IgE Calibrator Series IE2492 (lot 387-392IE) value assignment has now been aligned to the 3rd International Standard for human serum IgE 11/234. Turbidimetric…

Class IIFDA: TerminatedRandox Laboratories Ltd.

Medical DeviceOct 5, 2016

Prismatik Dentalcraft BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002 recall — FDA Z-2897-2016

Prismatik Dentalcraft is recalling BruxZir Shaded because the new design was manufactured at risk and were to be quarantined and held until the validation was completed. Prismatik failed to…

Class IIFDA: TerminatedPrismatik Dentalcraft, Inc.

Medical DeviceOct 5, 2016

R & D Systems R&D Systems, Quantikine IVD¿sTfR Immunoassay Kit, for the quantitative recall — FDA Z-2887-2016

R&D Systems, Inc. received two customer complaints that results of the Controls provided with the Quantikine IVD Human sTfR Immunoassay kit were out of the range high. Internal testing…

Class IIFDA: TerminatedR & D Systems, Inc.

Medical DeviceOct 5, 2016

Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 recall — FDA Z-2886-2016

The firm received multiple reports of Xhibit Telemetry System going offline or locking up. In addition, short-duration asystole alarms may not display an audio and visual alarm as reported…

Class IIFDA: TerminatedSpacelabs Healthcare Inc.

Medical DeviceOct 5, 2016

Trividia Health TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with recall — FDA Z-2881-2016

Product gives incorrect low blood glucose levels.

Class IIFDA: OngoingTrividia Health

Medical DeviceOct 5, 2016

Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe recall — FDA Z-2888-2016

In the vast majority of products specified, a shrinkage of the air chamber during sterilization has occurred. Because of these false high readings were displayed in the lower measuring…

Class IIFDA: TerminatedSpiegelberg Gmbh & Co. KG

Medical DeviceOct 5, 2016

Trividia Health TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with recall — FDA Z-2882-2016

Product gives incorrect low blood glucose levels.

Class IIFDA: OngoingTrividia Health

Medical DeviceOct 5, 2016

Medtronic CareLink iPro Version 1.10, Catalog No recall — FDA Z-2898-2016

Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp error.

Class IIFDA: TerminatedMedtronic Inc.

Medical DeviceOct 5, 2016

Siemens Medical Solutions USA Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT recall — FDA Z-2878-2016

Software patch installation to address several safety issues.

Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.

Medical DeviceOct 5, 2016

Siemens ADVIA Centaur Calibrator U, For in vitro diagnostic use in calibrating the following recall — FDA Z-2899-2016

Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal standardization

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceOct 5, 2016

Trividia Health TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with recall — FDA Z-2883-2016

Product gives incorrect low blood glucose levels.

Class IIFDA: OngoingTrividia Health

Medical DeviceOct 5, 2016

Beckman Coulter AQUIOS CL Flow Cytometer, Catalog No recall — FDA Z-2900-2016

Beckman Coulter is recalling the AQUIOS CL System because the use of the reagent carousel can lead to misalignment of the carousel and damage to the prep probe.

Class IIFDA: TerminatedBeckman Coulter 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.