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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.

29,496medical device recall records

2,407FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.784 records

Database records

Records — page 1140

29,496 detailed records are currently available in this category.

Medical DeviceOct 28, 2015

Biomet Microfixation Thinflap System Case The cases hold surgical instrumentation in place recall — FDA Z-0137-2016

The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.

Class IIFDA: TerminatedBiomet Microfixation, LLC

Medical DeviceOct 28, 2015

ConForMIS Unicondylar Knee Replacement System iUNI G2, Left Medial recall — FDA Z-0139-2016

May contain small amounts of ethylene glycol residue

Class IIFDA: TerminatedConforMIS, Inc.

Medical DeviceOct 28, 2015

Berchtold TELETOM EQUIPMENT MANAGEMENT SYSTEM 4 and 6 series TELETOM is designed for use in recall — FDA Z-0154-2016

During the use of the TELETOM Series 4 & 6 there is potential for the controls and brakes not to work properly due to fluid intrusion within the control switches and/or the control board…

Class IIFDA: TerminatedBerchtold Corp.

Medical DeviceOct 21, 2015

Viewray MRIdian ViewRay Radiation Therapy System, ViewRay Is indicated for stereotactic recall — FDA Z-0115-2016

ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling System (PHS, or couch), when attempting to restart the system, the couch could move unexpectedly.

Class IIFDA: TerminatedViewray Inc.

Medical DeviceOct 21, 2015

Micro Therapeutics Inc., Dba Ev3 Neurovascular -Pipeline Embolization Device -Pipeline Flex recall — FDA Z-0120-2016

The firm is recalling Pipeline and Pipeline Flex Embolization Devices from U.S. since the devices were shipped with an EU version of the Instructions for Use.

Class IIFDA: TerminatedMicro Therapeutics Inc., Dba Ev3 Neurovascular

Medical DeviceOct 21, 2015

Natus Neurology NicoletOne Software v5.94, Catalog/Part Number: 482-649600 recall — FDA Z-0117-2016

When using the NicoletOne v5.94 software, after exiting the impedance check function and returning to the EEG screen, the impedance check signal remains active in waveform, obscuring the…

Class IIFDA: TerminatedNatus Neurology Inc.

Medical DeviceOct 21, 2015

Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773 recall — FDA Z-0122-2016

Alere San Diego is recalling the Alere Cholestech LDX Multianalyte Control because the assigned control ranges for the Total Cholesterol (TC) and Triglyceride (TRG) analytes are incorrect.

Class IIIFDA: TerminatedAlere San Diego, Inc.

Medical DeviceOct 21, 2015

Clinical Innovations The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY recall — FDA Z-0123-2016

Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System (CTS-1000) Lot Number 1214-F-403.) to address the potential for a balloon leak which may affect the…

Class IIFDA: TerminatedClinical Innovations, LLC

Medical DeviceOct 21, 2015

Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile and Synthes recall — FDA Z-0124-2016

The 2.7MM/3.5MM VA-LCP Humerus Plates were found to be labeled incorrectly. Part number 02.117.410S was incorrectly etched with part number 02.117.610S

Class IIFDA: TerminatedSynthes (USA) Products LLC

Medical DeviceOct 21, 2015

Synthes Screw Inserter recall — FDA Z-0126-2016

Certain lots of the Screw Inserter may be etched with incorrect graphics. The orientation of the etched image of the oblique angle on the Screw Inserter may not correspond to the tip of the…

Class IIFDA: TerminatedSynthes (USA) Products LLC

Medical DeviceOct 21, 2015

Concentric Medical Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / recall — FDA Z-0116-2016

One Distal Access Catheter intended for distribution in Korea, was found at a US location.

Class IIFDA: TerminatedConcentric Medical Inc.

Medical DeviceOct 21, 2015

DJO Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with the Intelect recall — FDA Z-0121-2016

Overheating and burning of the wire insulation inside the applicator.

Class IIFDA: TerminatedDJO, LLC

Medical DeviceOct 21, 2015

Arrow International 4FR Single Lumen Pressure Injectable PICC recall — FDA Z-0127-2016

Labeling inaccuracy in the Instructions for Use (IFU) and Patient Card. The IFU and Patient Card with these products state the PICC can withstand up to ten (10) pressure injections,…

Class IIFDA: TerminatedArrow International Inc.

Medical DeviceOct 21, 2015

Zimmer Natural Nail CM Long recall — FDA Z-0119-2016

In about 5% of tested samples, the outer tray was found to be compromised. Risks: A damaged outer tray detected during surgery may cause a delay in surgery to obtain another implant. If a…

Class IIFDA: TerminatedZimmer Gmbh

Medical DeviceOct 14, 2015

GE Healthcare Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that recall — FDA Z-0023-2016

Images may be missing when a system parameter MapRoute is set to a value greater than 1.

Class IIFDA: TerminatedGE Healthcare

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 800524001, Sterile, LD0608A - C recall — FDA Z-0095-2016

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Class IIFDA: TerminatedResource Optimization & Innovation LLC

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 800407001, Sterile, OR0476A - Ortho recall — FDA Z-0088-2016

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Class IIFDA: TerminatedResource Optimization & Innovation LLC

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 800408001, Sterile, LD0477A recall — FDA Z-0089-2016

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Class IIFDA: TerminatedResource Optimization & Innovation LLC

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 800422, Sterile, OR0491 - Arthroscopy recall — FDA Z-0042-2016

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Class IIFDA: TerminatedResource Optimization & Innovation LLC

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 880327002, sterile, CV0758B - Open recall — FDA Z-0104-2016

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Class IIFDA: TerminatedResource Optimization & Innovation LLC

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 800416, Sterile, GY0485 - Robotic recall — FDA Z-0038-2016

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Class IIFDA: TerminatedResource Optimization & Innovation LLC

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 880323, Sterile, LD0754 - C Section recall — FDA Z-0079-2016

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Class IIFDA: TerminatedResource Optimization & Innovation LLC

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 800410001, Sterile, CV0479A - Open recall — FDA Z-0090-2016

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Class IIFDA: TerminatedResource Optimization & Innovation LLC

Medical DeviceOct 14, 2015

CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical recall — FDA Z-0105-2016

Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains vials Lidocaine HCl (1%)

Class IIIFDA: TerminatedCooperSurgical, 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.