Stay Informed

Get email alerts when new recalls match your interests.

Recall data is updated hourly from official government sources. Very recent recalls may not yet appear. About our data sources

About

We make U.S. recall data searchable and accessible for consumers and businesses.

Site

FAQ
Browse by State
Statistics
Recall Classifications
About
Enterprise API

Legal

Privacy Policy
Terms of Service
Report Incorrect Info

Official Sources

FDA Recalls ↗
USDA FSIS ↗
CPSC Recalls ↗
NHTSA Recalls ↗

RSS Feed

Home
/
Brands
/
Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK

Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK Recalls

All product recalls associated with Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK.

Get alerts for this brand

Recall Summary

Total Recalls

1000

Past Year

442

Class I (Serious)

138

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 7101–7120 of 7663 recalls

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 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

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.

1...354 355356357 358...384

Page 356 of 384Next

FDA

Sep 4, 2007

Nationwide

• Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK

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.

Cardinal Health 303 Inc DBA Alaris Products: Texium Closed Male Luer (CML), Model Number 10012241, Ca...

Leaks: there is a risk of leakage at the female end of the Texium closed male luer (CML) when attached to a spin luer. (NOTE: users who connect the female portion of the Texium closed male luer to fixed (one-piece) male luers on tubing or on syringes are not affected by this issue)

FDAAug 30, 2007AR, CA, CO +22 more• Cardinal Health 303 Inc DBA Alaris Products

Inotech Biosystems Intl., Inc: Inotech brand Heparin Adsorbant, Catalog #: HA-1, in 10m...

Erroneous Coagulation Tests

FDAAug 20, 2007Nationwide• Inotech Biosystems Intl., Inc

Pml Microbiologicals Inc.: Brain Heart Infusion Agar (BHIA) + Vancomycin 6 MCG/ML Mi...

Marketed a regulated product without a 510(k).

FDAAug 17, 2007PR• Pml Microbiologicals Inc.

Cardinal Health 303 Inc DBA Alaris Products: Pyxis Anesthesia System 3500, Cardinal Health, Clinical T...

System lock up; mini-drawers -under certain circumstances during use, are not accessable, delaying the user from accessing critical medications.

FDAAug 13, 2007Nationwide• Cardinal Health 303 Inc DBA Alaris Products

C.R. Bard Access Systems, Inc: Guidewire, 70cm x 1mm, REF 5583705, Sterile, Single Use, ...

Metal guidewires used in Hemodialysis Catheters may have been reverse loaded within the dispenser. Potential exists for the stiff end of the guidewire to be inserted into the patient instead of the flexible end.

FDAAug 10, 2007Nationwide• C.R. Bard Access Systems, Inc

Toshiba Notebook Battery (Sony) – fire risk (2007)

Fire/Burn Risk

The recalled lithium-ion batteries were sold with, or sold separately to be used with, the following notebook computer models: Satellite A100, Satellite A105 and Tecra A7. The battery model is printed on the battery. Model Computer Model Prefix Number (first 2 digits of serial number) Model Prefix (first 6 characters) Manufacturing Date Range Estimated Retail Pricing (when sold) Satellite A100 16, 26, 36, 46 PSAA0U January 1, 2006 - April 30, 2006 About $1,300 Satellite A105 16, 26, 36, 46 PSAA2U PSAA8U PSAA9U January 1, 2006 - April 30, 2006 About $1,000 Tecra A7 16, 26, 36, 46 PTA70U PTA71U January 1, 2006 - April 30, 2006 About $700

CPSCAug 9, 2007Nationwide• Sony Energy Devices Corp., of Japan (battery cells)

BD Diagnostic Systems Lee Laboratories: DIFCO Laboratories, FA Streptococcus Group A, 5mL, Catal...

Incorrect result: The product exhibited decreased fluorescence when testing with the homologous control organism.

FDAAug 8, 2007Nationwide• BD Diagnostic Systems Lee Laboratories

Golf Car (Club Car) – steering failure (2007)

The recall involves various 2007 model year gasoline or electric-powered vehicles used for transportation around golf courses, hotels, resorts, airports and residential communities. Vehicles can be identified by the serial number located above and to the right of the accelerator pedal.

CPSCAug 3, 2007Nationwide• Club Car Inc., of Augusta, Ga.

Raleigh Cadent Bicycle (Carbonage) – fork break risk (2007)

The recall involves the 2007 Raleigh Cadent 1.0, Cadent 2.0 and Cadent Carbon bicycle models with carbon forks. "Raleigh" is printed on the down tube of the bicycle, and the model name is printed on the top tube.

CPSCAug 3, 2007Nationwide• Carbonage Technology, of Baoan, China

Advanced Bionics Corp: Precision Implantable Pulse Generator (IPG), Model Number...

Mislabeled: Product labeled with the incorrect shelf-life information.

FDAAug 3, 2007MD• Advanced Bionics Corp

Cyberonics, Inc: Cyberonics VNS Therapy Bipolar Lead, Model #302; Sterile,...

Dissolution/Fractures to the leads of the VNS Therapy System

FDAAug 2, 2007Nationwide• Cyberonics, Inc

Cyberonics, Inc: Cyberonics Neuro Cyberonics Prosthesis System NCP Bipolar...

Dissolution/Fractures to the leads of the VNS Therapy System

FDAAug 2, 2007Nationwide• Cyberonics, Inc

Cyberonics, Inc: Cyberonics VNS Therapy Perrennia Lead, Model #303; Steril...

Dissolution/Fractures to the leads of the VNS Therapy System

FDAAug 2, 2007Nationwide• Cyberonics, Inc

Toro Power Sweep Blower (Toro) – projectile hazard (2007)

The recall involves Toro Power Sweep electric blower model 51586 that was manufactured between 2000 and 2002. The electric blowers have serial numbers that range between 000055100 and 220255609. There are two decals on the main housing of the blower. One decal reads, "TORO Power Sweep" and the decal on the opposite side of the blower contains the model number and serial number. The recalled units can be identified by a black impeller fan, which can be seen through the air inlet screen on the bottom of the unit.

CPSCJul 26, 2007Nationwide• The Toro Company, of Bloomington, Minn.

TV Stand (Sauder Woodworking) – collapse risk (2007)

The recalled TV Stand measures 23 ¾ inches (h) x 38 ½ inches (w) x 19 ½ inches (d) with a brushed maple finish. The stand has criss-cross, black, wrought-iron legs, a pull-out drawer, and a lower shelf. Model number 400205 and UPC number 42666 01958 are located on the product's carton and instructions.

CPSCJul 25, 2007Nationwide• Sauder Woodworking Co., of Archbold, Ohio

Nicolet Biomedical Div of Viasys Healthcare: BMSI "MicroJack" PN 672-510000 patient interface electrod...

The BMSI "MicroJack" patient interface electrode connection device used with the EEG monitor systems was found to be mis-wired. A complainant alleged that during depth electrode EEG study of a patient in preparation for brain surgery there was an observation that was perceived as non-logical data output.

FDAJul 17, 2007Nationwide• Nicolet Biomedical Div of Viasys Healthcare