Medical DeviceFeb 28, 2018
Zimmer Biomet ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device recall — FDA Z-0639-2018
Robot arm being sent to the wrong position
Class IIFDA: TerminatedZimmer Biomet, Inc.
27,577medical device recall records
2,338FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.784 records
Database records
Records — page 883
27,577 detailed records are currently available in this category.
Medical DeviceFeb 28, 2018
Ivoclar Vivadent Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number recall — FDA Z-0666-2018
Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and…
Class IIIFDA: TerminatedIvoclar Vivadent, Inc.
Medical DeviceFeb 28, 2018
Vygon MFG, Inc., dba/ Churchill Medical Systems Nutrisafe 2 35 mL Syringe for Safety recall — FDA Z-0678-2018
Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product,…
Class IIFDA: TerminatedVygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Medical DeviceFeb 28, 2018
Boston Scientific Innova Self-Expanding Stent System, 200 mm recall — FDA Z-0685-2018
Stent possibly unable to be fully released from the delivery system.
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceFeb 28, 2018
CRHF Implantable Cardioverter Defibrillators (ICDs), Evera recall — FDA Z-0587-2018
Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
Class IFDA: TerminatedMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medical DeviceFeb 28, 2018
CRHF Implantable Cardioverter Defibrillators (ICDs), Visia AF recall — FDA Z-0589-2018
Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
Class IFDA: TerminatedMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medical DeviceFeb 28, 2018
Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter is intended for use recall — FDA Z-0683-2018
Inform users of correct placement of the disposable adhesive pad on the QCPR meter and inform users of injuries associated with proper performance of CPR. As required by Consent Decree of…
Class IIFDA: TerminatedPhilips Electronics North America Corporation
Medical DeviceFeb 28, 2018
Covidien GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric recall — FDA Z-0640-2018
Reports of gastric or esophageal perforation occurring in procedures where the GastriSail" Gastric Positioning device has been used.
Class IIFDA: TerminatedCovidien LLC
Medical DeviceFeb 28, 2018
Med Tec Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1 recall — FDA Z-0671-2018
When an error message remains displayed and is not cleared in the Protura software with the Elekta pedestal coordinates, moving the pedestal could cause the Protura software to not update…
Class IIFDA: TerminatedMed Tec Inc.
Medical DeviceFeb 28, 2018
Arrow International Multi Lumen Central Venous Catheterization Kit with Blue FlexTip recall — FDA Z-0652-2018
These finished good kits may contain the incorrect Springwire Guide (SWG).
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceFeb 28, 2018
Ivoclar Vivadent Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number recall — FDA Z-0668-2018
Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and…
Class IIIFDA: TerminatedIvoclar Vivadent, Inc.
Medical DeviceFeb 28, 2018
CRHF Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva recall — FDA Z-0584-2018
Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
Class IFDA: TerminatedMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medical DeviceFeb 28, 2018
ZIMMER ORTHOPEDIC MFG NexGen LPS Femoral Component, Left and Right, Size G Replaces the recall — FDA Z-0663-2018
There is a possibility that the protective foam insert used during the packaging of the affected products is undersized, which may cause a breach in the inner cavity during transportation.
Class IIFDA: TerminatedZIMMER ORTHOPEDIC MFG LTD
Medical DeviceFeb 28, 2018
Roche Diagnostics Cobas 8000 Modular Series system recall — FDA Z-0675-2018
A software failure may incorrectly set the system settings to "default" settings, creating a risk of incorrect results.
Class IIFDA: TerminatedRoche Diagnostics Corporation
Medical DeviceFeb 28, 2018
Fujifilm Medical Systems U.S.A ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital recall — FDA Z-0661-2018
FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR¿1000AWS, FDR-2000AWS, FDR-3000AWS, and CR¿IR363AWS…
Class IIFDA: TerminatedFujifilm Medical Systems U.S.A., Inc.
Medical DeviceFeb 28, 2018
CRHF Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI recall — FDA Z-0588-2018
Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
Class IFDA: TerminatedMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medical DeviceFeb 28, 2018
Fujifilm Medical Systems U.S.A Aspire HD Plus, Aspire HD-s (for FDR-2000AWS) The Fujifilm recall — FDA Z-0660-2018
FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR¿1000AWS, FDR-2000AWS, FDR-3000AWS, and CR¿IR363AWS…
Class IIFDA: TerminatedFujifilm Medical Systems U.S.A., Inc.
Medical DeviceFeb 28, 2018
Merit Medical Systems PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath recall — FDA Z-0688-2018
Merit Medical Systems, Inc. is voluntarily conducting a recall of specific lots of Prelude SNAP Splittable Sheath Introducers due to an intermittent failure of the splittable hub.
Class IIFDA: TerminatedMerit Medical Systems, Inc.
Medical DeviceFeb 28, 2018
Allen Medical Bow Frame Model A-70800 recall — FDA Z-0641-2018
The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.
Class IIFDA: TerminatedAllen Medical Systems
Medical DeviceFeb 28, 2018
OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13 recall — FDA Z-0635-2018
The device software versions have an anomaly which may produce an erroneous marking for the quality specification value
Class IIFDA: TerminatedOculus Optikgeraete GMBH
Medical DeviceFeb 28, 2018
Hologic Rapid for the TLiIQ(R) System, HOLOGIC(R) recall — FDA Z-0677-2018
Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). The products were distributed to customers before FDA approved the change to use the material…
Class IIFDA: TerminatedHologic, Inc.
Medical DeviceFeb 28, 2018
Synthes LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini recall — FDA Z-0669-2018
May have difficulty attaching the drill sleeve to the plate. If the drill sleeve will not connect to the plate intraoperatively, surgical delay could occur. If the pilot hole is drilled…
Class IIFDA: TerminatedSynthes, Inc.
Medical DeviceFeb 28, 2018
Ivoclar Vivadent Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number recall — FDA Z-0667-2018
Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and…
Class IIIFDA: TerminatedIvoclar Vivadent, Inc.
Medical DeviceFeb 28, 2018
Medtronic TRILLIUM AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter,with Trillium recall — FDA Z-0646-2018
Possible sterile barrier breach in the pouch of Affinity NT Cardiotomy Venous Reservoir stand alone uncoated and Affinity NT Cardiotomy Venous Reservoir stand alone Trillium coated products.
Class IIFDA: TerminatedMedtronic Perfusion Systems
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.