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Medtronic Sofamor Danek USA Inc

Medtronic Sofamor Danek USA Inc Recalls

All product recalls associated with Medtronic Sofamor Danek USA Inc.

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Recall Summary

Total Recalls

1000

Past Year

583

Class I (Serious)

Most Recent

Dec 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 9641–9660 of 10937 recalls

Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek, 14 mm Satellite Sphere CoCr, Siz...

Labeling, including indications for use, lack 510 (K) approval

FDASep 13, 2007Nationwide• Medtronic Sofamor Danek USA Inc

Philips Medical Systems: Philips PageWriter Touch Cardiograph, Model: 860284, Phil...

Incorrect display: When using the 16 lead Patient Interface Module (PIM), lead tracings of V3R and V4R are reversed in the extended lead modes of Pediatric and Balanced.

FDASep 12, 2007Nationwide• Philips Medical Systems

Nicolet Biomedical Div of Viasys Healthcare: Viasys Healthcare NicoletOne ICU Monitor, Modular Neurod...

Display lock-up: VIASYS Healthcare NicoletOne ICU Monitor freezes up during operation when using the digital video option.

FDA

1...481 482483484 485...547

Page 483 of 547Next

Sep 11, 2007

Nationwide

• Nicolet Biomedical Div of Viasys Healthcare

Terumo Cardiovascular Systems Corp: Terumo Advanced Perfusion System, 1 Roller Pump, 4 inch d...

Failure to operate; The pump may fail to operate, and be difficult to hand crank, due to an internal electrical short condition.

FDASep 10, 2007AL, AZ, FL +7 more• Terumo Cardiovascular Systems Corp

Varian Medical Systems Inc: Varian brand Clinac, Accelerator, Linear, Medical charged...

The collimator drive chain may break or slip off of its drive track, allowing the collimator to rotate freely without motor control; if undetected resulting in a treatment with the wrong collimator angle.

FDASep 10, 2007Nationwide• Varian Medical Systems Inc

Varian Medical Systems Inc: Varian brand Clinac, Accelerator, Linear, Medical charged...

Treatment Error: The collimator drive chain may break or slip off of its drive track, allowing the collimator to rotate freely without motor control; if undetected resulting in a treatment with the wrong collimator angle.

FDASep 10, 2007Nationwide• Varian Medical Systems Inc

Philips Medical Systems (Cleveland) Inc: Philips Medical Systems, Cardiac Viewer or Pulmonary View...

Incorrect Measurement: Incorrect measurement will occur when the operator uses the distance or area measurement function, such as Graphic Tool line or ROI on zoomed and batch saved images from the Cardiac Viewer or Pulmonary Viewer and then views them in the CT Viewer or on a PACS System.

FDASep 10, 2007AL, AK, AZ +44 more• Philips Medical Systems (Cleveland) Inc

Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK: Medtronic Sofamor Danek COLORADO 2" SPINAL SYSTEM Break-O...

Assembly may be compromised: Two thread grooves are missing on the nut, which may cause damage to the bone screw and result in the need for the bone screw to be replaced.

FDASep 10, 2007Nationwide• Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK

BD Biosciences, Systems & Reagents: CellQuest Pro SW, version 4.0.2. and later; Becton Dickin...

Results and gates could be mismatched if you utilize the undo function to undo a gate that was deleted.

FDASep 7, 2007Nationwide• BD Biosciences, Systems & Reagents

Ventana Medical Systems Inc: Ventana Medical System's Symphony Staining System, KPA, M...

Shock hazard: Devices released prior to full testing; the configuration of the Symphony instrument during Hi pot testing procedures did not completely evaluate all components in the test loop. In specific circumstances, a shock hazard exists.

FDASep 6, 2007Nationwide• Ventana Medical Systems Inc

BD Diagnostic Systems Lee Laboratories: BD DifcoTM Neisseria Meningitidis Antisera Group Y, 2288...

Exhibits cross reactivity with Neisseria meningitides Group W135.

FDASep 6, 2007Nationwide• BD Diagnostic Systems Lee Laboratories

Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek, Prestige Cervical Disc System, I...

Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated.

FDASep 4, 2007Nationwide• Medtronic Sofamor Danek USA Inc

Philips Medical Systems: HeartStart XL Defibrillator/Monitor, Model: M4735A

Inadequate shipping package causing damage to control boards resulting in unit failure. Failure to deliver therapy (defibrillation, pacing or cardioversion) may occur as a result of undetected damage to the PCB assembly.

FDASep 4, 2007PR• Philips Medical Systems

Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK: Medtronic Sofamor Danek METRx (TM) System Bayonet Electro...

Packaging weakness may compromise sterility and instructions for use are inadequate.

FDASep 4, 2007Nationwide• Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK

GE Healthcare Clinical Systems: GE LOGIQ 3 Expert ultrasound scanner with software versio...

Inaccurate guidelines: The BE9C is an optional, small radius Bi-planar convex probe intended for use with the LOGIQ 3 Expert system in Urology application. An attempt by the user to activate the biopsy guidelines while this probe is in use will cause incorrect guidelines to be displayed on the image. The incorrect guidelines are recognized by their orientation that is left/right reversed from t

FDASep 4, 2007AL, NY• GE Healthcare Clinical Systems

Toe-Space Electric Heaters (Berko Electric) – Fire Hazard (2007)

Fire/Burn Risk

The recall involves electric, toe-space heaters typically installed in kitchens and bathrooms at floor level in the recessed space under cabinets. The recall includes Berko Electric catalog numbers TS, TS-1 and TS-1A and Emerson Electric "Chromalox Comfort Heating" and "Environmental Products" catalog number KSH2000. The heater is controlled by a wall thermostat or a thermostat mounted on the front of the heater. The heater has a removable, black metal grille that measures 23 1/2 inches wide and 3 1/2 inches tall with five sets of openings, each with seven horizontal louvers.

CPSCAug 30, 2007Nationwide• Berko Electric, of Peru, Ind., now known as Marley Engineered Products, of Bennettsville, S.C.

Toshiba American Med Sys Inc: NEMIO XG Ultrasound System, Model SSA-580A , Software ver...

Multiple problems including : (1) The surface temperature of the transducer tip can rise and exceed the limit set by the international standard. (2) Incorrect display of the TI indices on the display monitor. The displayed value is greater or smaller than the true TI value, and (3) Manuals contain incorrect values for MI/TI values.

FDAAug 29, 2007Nationwide• Toshiba American Med Sys Inc

Toshiba American Med Sys Inc: NEMIO Ultrasound System, Model SSA-550A , Software versi...

FDAAug 29, 2007Nationwide• Toshiba American Med Sys Inc

Logger Boots (Wolverine) – Electrical Shock Risk (2007)

This recall involves Caterpillar brand steel toe logger boots. The boots were sold in women's and men's sizes. Women's boots were sold in black and have stock number P88030. Men's boots were sold in brown and black and have stock numbers P88033 or P88034. Stock numbers are printed on a label on the tongue of the shoe. The Caterpillar logo and "EH" are also printed on the label. The word "Caterpillar" is printed on the outside of the boots.

CPSCAug 28, 2007Nationwide• Wolverine World Wide Inc., of Rockford, Mich.

Medtronic Inc. Cardiac Rhythm Managment: Medtronic Paceart System, 2006 Edition, Medtronic, Inc. 7...

An issue with the Paceart System - 2006 First Edition (Get Connected Edition) exists. Under certain circumstances, Paceart System Generic ICD reports may not accurately reflect patient VT/VF, SVT/NST and Mode Switch/AT/AF episode detection data. When episode detection data is imported into the Paceart System from certain sources, the Paceart System Generic ICD reports display a zero, suggesting

FDAAug 27, 2007Nationwide• Medtronic Inc. Cardiac Rhythm Managment