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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

731

Class I (Serious)

175

Most Recent

Jan 2026

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 10141–10160 of 11123 recalls

Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek, 13 mm Satellite Sphere CoCr, Siz...

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

FDASep 13, 2007Nationwide• Medtronic Sofamor Danek USA Inc

Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek, 8 mm Trial, size 8 mm, Material ...

Marketed without approval: The surgical technique includes reference to an 8mm Trial and 8mm Curette, while the cleared -510 (k)- device only includes spheres between 9.5 and 19 mm.

FDASep 13, 2007Nationwide• Medtronic Sofamor Danek USA Inc

Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek, 16 mm Satellite Sphere CoCr, Siz...

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

FDA

1...506 507508509 510...557

Page 508 of 557Next

Sep 13, 2007

Nationwide

• Medtronic Sofamor Danek USA Inc

Medtronic Sofamor Danek USA Inc: Satellite Spinal System Surgical Technique, LITSATFUSST7-...

Surgical manual/technique lack information required as a condition of the 510(k) approval.

FDASep 13, 2007Nationwide• Medtronic Sofamor Danek USA Inc

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

Steris Corporation Hopkins Facility: Steris QFC1728 and QFC1729 Quick Connects;(used to connec...

Loose or missing adaptor: The center insert of the adaptor #6 restrictor could become loose and/or come out of the adaptor's housing. The absence of adaptor #6's center insert may affect the sterilization process of the attached endoscope.

FDASep 12, 2007Nationwide• Steris Corporation Hopkins Facility

Stryker Howmedica Osteonics Corp.: Stryker Orthopaedics PAL Pelvic Alignment Level, Ref: PAL...

The bubble in a vial of the Pelvic Alignment Level (PAL) was wider than the level marking. Upon opening the PAL and removing the vial, it was discovered that the vial was leaking

FDASep 11, 2007Nationwide• Stryker Howmedica Osteonics Corp.

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

Metrika Inc: A1CNOW+ with sampler 10-Test Kits (Product No: 3022), Me...

Incorrect Test Results: Due to manufacturing errors regarding temperature compensation factors, the device will give erroneously high results if the test is performed below 70 degrees Fahrenheit.

FDAAug 31, 2007Nationwide• Metrika Inc

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.

Stryker Howmedica Osteonics Corp.: Trident PSL HA Cluster Acetabular Shell; Arc Deposited HA...

Stryker Orthopaedics had identified that specific lots of Trident PSL Acetabular shells may have a dimensional discrepancy. The deviation regarding the difference in wall thickness will increase the gap between the shell and liner on one side and will decrease the gap between shell and liner on the opposing side, resulting in interference.

FDAAug 30, 2007Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: HA Solid Back Acetabular Shell; Arc Deposited HA Coated I...

FDAAug 30, 2007Nationwide• Stryker Howmedica Osteonics Corp.

Beckman Coulter Inc: Vidiera NsP Nucleic Sample Preparation, Part Number: A224...

Incorrect results: under certain circumstances, when transfer volume is not within the set range, the Vidiera NsP software does not report sample exclusion and does not flag the excluded sample in the "Run Results" report. The software error associated with the excluded sample appears as "Liquid was not successfully transferred to well#..........the sample will be excluded from further proce

FDAAug 30, 2007Nationwide• Beckman Coulter Inc

Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek, TSRH SiLo 5.5 Spinal System, Sag...

Disassembly: The movable cradle component could detach from the saddle under extreme manipulation of the associated rods prior to final tightening of the set screws.

FDAAug 24, 2007Nationwide• Medtronic Sofamor Danek USA Inc

Mallinckrodt Inc: Angiomat Illumena Injector with Auxiliary Console, Mallin...

Synchronization problems: units that have both a main programmable console and an auxiliary programmable console, when simultaneously, injection parameters are programmed into the unit's main console and the unit's auxiliary consoles, mis-synchronization could occur resulting in a variance between the intended injection parameters (those programmed) and the actual parameters of the injection deliv

FDAAug 24, 2007AL, AZ, CA +27 more• Mallinckrodt Inc

Backpack Blowers (Shindaiwa) – Fire Risk (2007)

Fire/Burn Risk

This recall involves Shindaiwa Models EB8510 and EB8510RT. All models up to serial #7025018 are included. After serial number 7025018, the leaf blower has been upgraded with stainless steel muffler shells. The backpack blowers weight approximately 24 pounds and include Serial Numbers through February 2007 production (S/N 702XXXX) which are located on the side label. These machines are blue, with a red label that reads "Shindaiwa".

CPSCAug 24, 2007Nationwide• Shindaiwa Kogyo Co., Ltd., Hiroshima, Japan

Elekta, Inc.: Desktop Pro 4.2, 5.0, 5.1, 6.0, 6.2 A user interface of ...

Under certain conditions it has been found that movement of the collimators can be induced during multi segment beams such as IMRT and Omniwedge which will not be detected by the Desktop Pro if high values are sent within the iCom tolerance table.

FDAAug 23, 2007PR• Elekta, Inc.

Sleepi Crib Mattresses (Stokke) – Entrapment Risk (2007)

Only oval shaped Sleepi cribs with foam mattresses sold under the following model numbers are the subject of this recall: 660321, 660320, 660301,660305, 660318, 652268, 652269, 652246, 652247 and 652248. The cribs were sold in a variety of colors, including white, walnut, natural, cherry and whitewash. The model number can be found on the packaging and underside of the crib.

CPSCAug 23, 2007Nationwide• Stokke, of Kennesaw, Ga.

Trucks Shaker Teether Books (Priddy) – Choking Hazard (2007)

Choking Hazard

The recalled cloth teether book, entitled "trucks", has a yellow dump truck on the front cover on a blue background. Attached to the top of the book is a yellow rattle with a green teether attached on the right side of the rattle and an orange teether attached to the left side of the rattle.

CPSCAug 23, 2007Nationwide• St. Martin's Press, LLC, of New York, N.Y.

Beckman Coulter Inc: Cytomics FC 500 Flow Cytometry System with Data Innovatio...

Labeling provided by two integrated software systems are not clear enough to avoid potential demographic and sample type mismatches under certain conditions.

FDAAug 20, 2007Nationwide• Beckman Coulter Inc