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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 1144

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

Medical DeviceOct 14, 2015

Beckman Coulter Access Free T3 Reagent Kit, P/N A13422 The Access Free T3 assay is a recall — FDA Z-0110-2016

Beckman Coulter, Inc. is recalling Access Free T3 Reagent Kit because they were filled incorrectly and contain insufficient quantity of reagents in one or more of the pack wells.

Class IIFDA: TerminatedBeckman Coulter Inc.

Medical DeviceOct 14, 2015

Beckman Coulter MICroSTREP plus 2 Panel, Part No recall — FDA Z-0109-2016

Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturing error may lead to antimicrobic degradation and the potential for elevated or false…

Class IIFDA: TerminatedBeckman Coulter Inc.

Medical DeviceOct 14, 2015

Siemens Medical Solutions USA Syngo RT Oncologist, an optional accessory to the linear recall — FDA Z-0106-2016

This update is intended to provide a software update for the Syngo RT Oncologist, which is currently running SW version 4.2 or 4.3. The safety-related issues, which were described in the…

Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number 800567001, Sterile, GY0656A - Robotic recall — FDA Z-0101-2016

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

Medtronic Medical Device Identification Card for SureScan pacemaker patients recall — FDA Z-0022-2016

Some Medical Device Identification Cards provided to SureScan pacemaker patients indicate they have a complete Magnetic Resonance (MR) Conditional system, when in fact, not all of their…

Class IIFDA: TerminatedMedtronic Inc. Cardiac Rhythm Disease Management

Medical DeviceOct 14, 2015

Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular recall — FDA Z-0024-2016

Affected lots of Periarticular Aiming Arms and Insertion Handles (Part Numbers 03.120.001, 03.120.002, 03.120.004 and 03.120.005) for the 4.5 mm LCP Proximal Tibia Plates are not able to be…

Class IIFDA: TerminatedSynthes (USA) Products LLC

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 800413, Sterile, CV0482 - Vascular Pk recall — FDA Z-0035-2016

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: 800528001, Sterile, GS0612A - Lap recall — FDA Z-0096-2016

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: 800599, Sterile, GS0694 - Robotic Lap recall — FDA Z-0074-2016

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

Elekta Monaco Radiation Treatment Planning System recall — FDA Z-0112-2016

Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities.

Class IIFDA: TerminatedElekta, Inc.

Medical DeviceOct 14, 2015

Siemens Medical Solutions USA SOMATOM Definition Flash recall — FDA Z-0020-2016

software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Correction…

Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 800569, Sterile, CV0659 - Open Heart recall — FDA Z-0072-2016

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: 800414, Sterile, OR0483 - Total Joint recall — FDA Z-0036-2016

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

Class IIFDA: TerminatedResource Optimization & Innovation LLC

Medical DeviceOct 7, 2015

Biosense Webster SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters recall — FDA Z-0003-2016

Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion. Affects the CARTOSOUND…

Class IIFDA: TerminatedBiosense Webster, Inc.

Medical DeviceOct 7, 2015

Zimmer Guide Wires for orthopedic procedures recall — FDA Z-2820-2015

Product labeling of these sterile guide wires (external carton label and patient record label) states a 10-year expiration date. Package testing supports a 5-year expiration date for these…

Class IIFDA: TerminatedZimmer, Inc.

Medical DeviceOct 7, 2015

STERILMED Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown recall — FDA Z-2819-2015

Sterilmed, Inc. is recalling its reprocessed Zimmer Tourniquet Cuff, Part #ZIM60-7075-106, lot number 1846885 due to mislabeling. The affected reprocessed product is labeled as single hose…

Class IIFDA: TerminatedSTERILMED, Inc.

Medical DeviceOct 7, 2015

Ferno-Washington Ferno iNX Wheeled Stretcher, Integrated Patient Transport & Loading System recall — FDA Z-2826-2015

Hole elongation in the telescoping load frame channel. A hole elongation could affect the ability of the retention pin to stay seated which is necessary to preclude movement of the…

Class IIFDA: TerminatedFerno-Washington Inc.

Medical DeviceOct 7, 2015

Lifeline Systems Philips GoSafe Mobile Help Button recall — FDA Z-0004-2016

Irregular battery disconnection resulted in issues with Mobile Health Button (MHB) Charging.

Class IIFDA: TerminatedLifeline Systems, Inc.

Medical DeviceOct 7, 2015

Medtronic Navigation P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST recall — FDA Z-2824-2015

Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery.

Class IIFDA: TerminatedMedtronic Navigation, Inc.

Medical DeviceOct 7, 2015

Biosense Webster Carto 3 EP Navigation System recall — FDA Z-0002-2016

Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion. Affects the CARTOSOUND…

Class IIFDA: TerminatedBiosense Webster, Inc.

Medical DeviceOct 7, 2015

MicroPort Orthopedics PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION recall — FDA Z-2743-2015

Unexpected rate of postoperative fractures resulting in the need for revision surgery.

Class IFDA: TerminatedMicroPort Orthopedics, Inc.

Medical DeviceOct 7, 2015

US Endoscopy Group Histolock Resection Device, US Endoscopy recall — FDA Z-0001-2016

The company has determined the sterility cannot be assured for the affected lot.

Class IIFDA: TerminatedUS Endoscopy Group Inc.

Medical DeviceOct 7, 2015

Olympus Corporation of the Americas EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180 recall — FDA Z-2818-2015

Insufficient information for specific cleaning accessories used for the cleaning and reprocessing of the GF-UCT180 ultrasound endoscope

Class IIFDA: TerminatedOlympus Corporation of the Americas

Medical DeviceOct 7, 2015

Medtronic Navigation P/N: 9735023, DRIVER 9735023 SOLERA 5.5/6.0 MAS recall — FDA Z-2823-2015

Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery.

Class IIFDA: TerminatedMedtronic Navigation, 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.