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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.

26,628medical device recall records

2,311FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.778 records

Database records

Records — page 740

26,628 detailed records are currently available in this category.

Medical DeviceApr 24, 2019

Integra LifeSciences Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 1 recall — FDA Z-1155-2019

The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU

Class IIFDA: TerminatedIntegra LifeSciences Corp.

Medical DeviceApr 24, 2019

Integra LifeSciences Talar Dome Total Ankle Prosthesis, Flat Cut, Size 1, Left, Product No recall — FDA Z-1162-2019

The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU

Class IIFDA: TerminatedIntegra LifeSciences Corp.

Medical DeviceApr 24, 2019

ICU Medical icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S recall — FDA Z-1093-2019

There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.

Class IFDA: TerminatedICU Medical, Inc.

Medical DeviceApr 24, 2019

ICU Medical icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S recall — FDA Z-1092-2019

There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.

Class IFDA: TerminatedICU Medical, Inc.

Medical DeviceApr 24, 2019

ICU Medical icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp recall — FDA Z-1095-2019

There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.

Class IFDA: TerminatedICU Medical, Inc.

Medical DeviceApr 24, 2019

Integra LifeSciences Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Right, Product No recall — FDA Z-1170-2019

The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU

Class IIFDA: TerminatedIntegra LifeSciences Corp.

Medical DeviceApr 24, 2019

Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: The Alinity c processing recall — FDA Z-1197-2019

The safety interlock covering the septum piercing probes within the bulk solution bottle holder may not deploy when a bulk solution bottle is removed from the Alinity ci series and Alinity…

Class IIFDA: TerminatedAbbott Gmbh & Co. KG

Medical DeviceApr 24, 2019

Integra LifeSciences Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Right, Product No recall — FDA Z-1171-2019

The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU

Class IIFDA: TerminatedIntegra LifeSciences Corp.

Medical DeviceApr 24, 2019

Integra LifeSciences Talar Dome Total Ankle Prosthesis , Flat Cut, Size 3, Left, Product No recall — FDA Z-1164-2019

The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU

Class IIFDA: TerminatedIntegra LifeSciences Corp.

Medical DeviceApr 24, 2019

Wilson-Cook Medical Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an recall — FDA Z-1132-2019

Complaints of the snare loop not completely retracting and/or misshaping of the snare loop.

Class IIFDA: TerminatedWilson-Cook Medical Inc.

Medical DeviceApr 24, 2019

Integra LifeSciences Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Left, Product No recall — FDA Z-1163-2019

The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU

Class IIFDA: TerminatedIntegra LifeSciences Corp.

Medical DeviceApr 24, 2019

Topcon Medical Systems IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software recall — FDA Z-1138-2019

When a patient is selected in the patient data and another patient is selected prior to the display of the primary patient's thumbnails is completed, then the primary patient's thumbnails…

Class IIFDA: TerminatedTopcon Medical Systems, Inc.

Medical DeviceApr 24, 2019

Integra LifeSciences Salto Talaris Tibial Ankle Prosthesis Tray, Talar Dome, Size 1, Right recall — FDA Z-1151-2019

The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU

Class IIFDA: TerminatedIntegra LifeSciences Corp.

Medical DeviceApr 24, 2019

Integra LifeSciences Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Right, Product No recall — FDA Z-1166-2019

The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU

Class IIFDA: TerminatedIntegra LifeSciences Corp.

Medical DeviceApr 24, 2019

Ethicon PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intended for recall — FDA Z-1136-2019

VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.

Class IIFDA: TerminatedEthicon, Inc.

Medical DeviceApr 24, 2019

Integra LifeSciences Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Right, Product No recall — FDA Z-1169-2019

The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU

Class IIFDA: TerminatedIntegra LifeSciences Corp.

Medical DeviceApr 24, 2019

GE Healthcare Innova IGS 6, Interventional Fluoroscopic X-Ray System used in generating recall — FDA Z-1201-2019

There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing the fluoroscopy footswitch pedal…

Class IIFDA: OngoingGE Healthcare, LLC

Medical DeviceApr 24, 2019

Philips Medical Systems Nederlands Foot Switches used with the following systems: 722001 recall — FDA Z-1141-2019

Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get…

Class IIFDA: TerminatedPhilips Medical Systems Nederlands

Medical DeviceApr 24, 2019

Integra LifeSciences Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Left, Product No recall — FDA Z-1175-2019

The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU

Class IIFDA: TerminatedIntegra LifeSciences Corp.

Medical DeviceApr 24, 2019

Integra LifeSciences Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Right, Product No recall — FDA Z-1168-2019

The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU

Class IIFDA: TerminatedIntegra LifeSciences Corp.

Medical DeviceApr 24, 2019

BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile recall — FDA Z-1148-2019

The firm became aware of the potential for the products' sterile pouch to be punctured during transit. The packaging failure may introduce a non-sterile device that may lead to patient…

Class IIFDA: TerminatedBioventus, LLC

Medical DeviceApr 24, 2019

Abbott Alinity i Processing Module LN 03R65-01 - Product Usage: The Alinity i processing recall — FDA Z-1196-2019

The safety interlock covering the septum piercing probes within the bulk solution bottle holder may not deploy when a bulk solution bottle is removed from the Alinity ci series and Alinity…

Class IIFDA: TerminatedAbbott Gmbh & Co. KG

Medical DeviceApr 24, 2019

Ethicon VICRYL PLUS Sutures: VICRYL PLUS SUTURE 18"(45CM) 3-0 VIO VICRYL PLUS SUTURE recall — FDA Z-1135-2019

VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.

Class IIFDA: TerminatedEthicon, Inc.

Medical DeviceApr 24, 2019

Integra LifeSciences Tibial Total Ankle Prosthesis Tray, Size 1, Product No recall — FDA Z-1159-2019

The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU

Class IIFDA: TerminatedIntegra LifeSciences Corp.

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.