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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 1031

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

Medical DeviceOct 19, 2016

A & D Enginering Blood Pressure Monitor UA-767PBT-Ci for small cuff recall — FDA Z-0063-2017

A&D may have shipped blood pressure monitors that were not labeled for use with small cuff.

Class IIFDA: TerminatedA & D Enginering Inc.

Medical DeviceOct 12, 2016

Ivoclar Vivadent Zenostar MT Color A2 60ml, art. no. 681051 recall — FDA Z-0022-2017

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 A1 60ml, art. no. 681050, Product Usage: For coloring recall — FDA Z-0021-2017

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

Trumpf Medical Systems Operating Table TruSystem 7000 U, Material Number 1604788 recall — FDA Z-0043-2017

Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.

Class IIFDA: TerminatedTrumpf Medical Systems, Inc.

Medical DeviceOct 12, 2016

Ivoclar Vivadent Zenostar MT Color Impulse orange, art. no. 681168 recall — FDA Z-0037-2017

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

Trumpf Medical Systems Mobile Column TruSystem 7500, Material Number 1717023 recall — FDA Z-0040-2017

Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.

Class IIFDA: TerminatedTrumpf Medical Systems, Inc.

Medical DeviceOct 12, 2016

Philips Medical Systems Ingenuity Core Model Number 728321 Product Usage: Computed recall — FDA Z-0010-2017

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

Ivoclar Vivadent Zenostar MT Color D3 60ml, art. no. 681064 recall — FDA Z-0035-2017

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 Stationary X-Ray System Product Usage: The recall — FDA Z-0013-2017

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

New Star Lasers ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision recall — FDA Z-2916-2016

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

Trumpf Medical Systems Floor Mounting Column TS 7500 U, Material Number 1730732 recall — FDA Z-0042-2017

Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.

Class IIFDA: TerminatedTrumpf Medical Systems, Inc.

Medical DeviceOct 12, 2016

Ivoclar Vivadent Zenostar MT Color C2 60ml art. no. 681060 recall — FDA Z-0031-2017

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 LifeSciences Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary recall — FDA Z-2907-2016

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-0047-2017

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

Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a recall — FDA Z-2909-2016

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

New Star Lasers CT3Plus (a.k.a. CT3PZ) recall — FDA Z-2914-2016

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

Merit Inflation Syringe Kit recall — FDA Z-0002-2017

Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit labels missing required device labeling information.

Class IIFDA: TerminatedMerit Medical Systems, Inc.

Medical DeviceOct 12, 2016

Ivoclar Vivadent Zenostar MT Color A3.5 60ml, art. no. 681053 recall — FDA Z-0024-2017

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

Trumpf Medical Systems Stationary Column TruSystem 7599, Material Number 1717020 Patient recall — FDA Z-0041-2017

Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.

Class IIFDA: TerminatedTrumpf Medical Systems, Inc.

Medical DeviceOct 12, 2016

Philips Medical Systems Ingenuity CT Model Number 728326 Product Usage: Computed Tomography recall — FDA Z-0012-2017

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

Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will recall — FDA Z-0016-2017

Panoramic Corporation is performing a voluntary Medical Device Correction on certain PC-1000 X-ray systems due to the potential for a safety nut to be ineffective, which could result in…

Class IIFDA: TerminatedPanoramic Rental Corp.

Medical DeviceOct 12, 2016

Baxter Corporation Englewood 0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter recall — FDA Z-0007-2017

Baxter Healthcare Corporation is issuing a voluntary product recall for all unexpired lots of the 50mm 0.2 Micron Filter (Product Code: H93835) due to the potential for the filter membrane…

Class IFDA: TerminatedBaxter Corporation Englewood

Medical DeviceOct 12, 2016

LDR Spine USA ROI-A Anterior Delivery Device recall — FDA Z-0045-2017

The ROI-A Anterior Delivery Device T-Handle, part number SI-ROIA-0023 has experienced binding of the rotation of the t-handle. There have been no reports of patient injury

Class IIFDA: TerminatedLDR Spine USA, Inc.

Medical DeviceOct 12, 2016

Ivoclar Vivadent Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For recall — FDA Z-0020-2017

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.

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.