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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.

28,535medical device recall records

2,363FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.784 records

Database records

Records — page 1032

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

Medical DeviceOct 12, 2016

Ivoclar Vivadent Zenostar MT Color D4 60ml, art. no. 681065 recall — FDA Z-0036-2017

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

Argon Medical Devices MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo recall — FDA Z-0051-2017

The supplier initiated a recall because affected lots of the micro-introducer have an outer diameter of the dilator hub that is slightly smaller than is capable of securing the dilator to…

Class IIFDA: TerminatedArgon Medical Devices, Inc.

Medical DeviceOct 12, 2016

Siemens Healthcare Diagnostics Dimension Vista Calcium (CA) Flex reagent cartridge Device recall — FDA Z-0039-2017

Siemens Healthcare Diagnostics determined that the Dimension Vista Calcium (CA) Flex reagent cartridge lot # 16060BB may produce erroneously low or high results from specific well sets.

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceOct 12, 2016

Ivoclar Vivadent Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring recall — FDA Z-0017-2017

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

Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner recall — FDA Z-0046-2017

It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning may be interrupted and rebooting…

Class IIFDA: TerminatedToshiba American Medical Systems Inc.

Medical DeviceOct 12, 2016

Ivoclar Vivadent Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring recall — FDA Z-0019-2017

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 B3 60ml, art. no. 681057 recall — FDA Z-0028-2017

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

Zimmer Biomet Vanguard 360 Revision Knee System Knee prostheses recall — FDA Z-0003-2017

The drill bit used to drill the hex pre-drilled hole in the screw head of the Tibial Augment Bolts included in the Vanguard 360 Revision Knee System was larger than allowable per the…

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceOct 12, 2016

Ivoclar Vivadent Zenostar MT Color A4 60ml, art. no. 681054 recall — FDA Z-0025-2017

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

Microgenics Thermo Scientific QMS Everolimus Assay recall — FDA Z-0008-2017

A reagent stability issue (still under investigation) causes less separation in the calibration curve, which affects results across the entire range. For controls, maximum bias of +/- 35%…

Class IIFDA: TerminatedMicrogenics Corporation

Medical DeviceOct 12, 2016

Northridge Tri-Modality Imaging TriFoillmaging Triumph/Triumph II Research CT scanners recall — FDA Z-2833-2016

The Firm has determined that several Triumph/Triumph II Research CT scanners produced by Northridge Trimodality Imaging, inc dba TriFoillmaging (or by Gamma Medica-Ideas, Inc and field…

Class IIFDA: TerminatedNorthridge Tri-Modality Imaging,

Medical DeviceOct 12, 2016

Ivoclar Vivadent Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For recall — FDA Z-0018-2017

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

Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in one Tyvek recall — FDA Z-2908-2016

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

Toshiba America Medical Systems, Inc recall — FDA Z-0048-2017

It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning may be interrupted and rebooting…

Class IIFDA: TerminatedToshiba American Medical Systems Inc.

Medical DeviceOct 12, 2016

Toshiba America Medical Systems, Inc recall — FDA Z-0049-2017

It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning may be interrupted and rebooting…

Class IIFDA: TerminatedToshiba American Medical Systems Inc.

Medical DeviceOct 12, 2016

Ivoclar Vivadent Zenostar MT Color B1 60ml, art. no. 681055 recall — FDA Z-0026-2017

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 C4 60ml, art. no. 681062 recall — FDA Z-0033-2017

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 D2 60ml, art. no. 681063 recall — FDA Z-0034-2017

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

Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, packaged in a Tyvek recall — FDA Z-2905-2016

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 B4 60ml, art. no. 681058 recall — FDA Z-0029-2017

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

Cardinal Health BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE recall — FDA Z-2917-2016

Blue Impervious Gown with thumbhooks, X-large. All lots do not meet design specifications, specifically 16 CFR 1611 - Standard for the Flammability of Vinyl Plastic Film. The standard…

Class IIFDA: TerminatedCardinal Health

Medical DeviceOct 12, 2016

Integra LifeSciences CUSA Dissectron Fingertip Laparoscopic Cannula, REF F75221, Sterile EO recall — FDA Z-2906-2016

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

Philips Medical Systems Brilliance 64 CT Model Number 728231 Product Usage: Computed recall — FDA Z-0009-2017

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

Terumo Cardiovascular Systems CDI H/S Cuvette The intended use for the CDI H IS Cuvette is recall — FDA Z-0001-2017

Terumo Cardiovascular Systems (Terumo CVS) has received complaints of the CDI System 500 monitor displaying the H/S DISCONNECT AT CUVETTE error message when the CDI H/S Cuvette does not…

Class IIIFDA: TerminatedTerumo Cardiovascular Systems Corporation

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.