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Biocare Systems Inc.

Biocare Systems Inc. Recalls

All product recalls associated with Biocare Systems Inc..

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Recall Summary

Total Recalls

1000

Past Year

620

Class I (Serious)

91

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 10021–10040 of 10937 recalls

Biocare Systems Inc.: LumiWave 1X4 Infrared Therapy Device, Catalog # LW1X4, Bi...

Electrical Safety Hazard-when pulling on the cord of the AC adapter, to remove it from an outlet, the prongs on the AC adapter, may detach from the unit, damaging it and exposing the user to an electrical safety hazard

FDAJun 14, 2006Nationwide• Biocare Systems Inc.

Medtronic Neuromodulation: Medtronic SynchroMed EL Programmable Pumps, Models 8627-1...

The Catheter Access Port (CAP) on SynchroMed EL pumps manufactured between March and July 1999 may detach from the main body of the pump, which can interrupt drug flow to the target site.

FDAJun 6, 2006Nationwide• Medtronic Neuromodulation

Varian Medical Systems Inc: Varian brand Clinac C-series Pendant Radiation delivery s...

Machine may produce unexpected motions from the couch, collimator, and gantry rotation at maximum speeds.

1...500 501502503 504...547

Page 502 of 547Next

FDA

Jun 6, 2006

Nationwide

• Varian Medical Systems Inc

Brainlab AG Ammerthalstrasse 8 Kirchheim B. Muenchen Germany: ExacTrac Robotics, sold alone as Robotic Tilt Module cata...

During ExacTrac Robotics installation on the Varian Exact Couch, the couch height position indication is re-calibrated to read out the correct positions. This re-calibration could cause the eventual failure of the vertical lift mechanism of the couch, which might result in patient injury or death.

FDAJun 2, 2006Nationwide• Brainlab AG Ammerthalstrasse 8 Kirchheim B. Muenchen Germany

St Jude Medical CRMD: CPS Aim, Models 410140, 410141, 410142, 410144, 410145, 4...

Sterility-Some of the sterile pouches in which these products are packaged may not have been properly sealed during their packaging process.

FDAJun 1, 2006AZ, CA, IN +3 more• St Jude Medical CRMD

St Jude Medical CRMD: CPS Direct SL, Models 410110, 410111, 410112, 410113, 410...

Sterility-Some of the sterile pouches in which these products are packaged may not have been properly sealed during their packaging process.

FDAJun 1, 2006AZ, CA, IN +3 more• St Jude Medical CRMD

GE Medical Systems LLC: GE Healthcare-Americas Signa 3.0T EXCITE Whole Body Magne...

To provide the 3.0T MRI systems users with the 8-channel brain coil the proper coil weighting software. The proper coil weighting factors for the eight-channel brain coil were not included in the software.

FDAJun 1, 2006Nationwide• GE Medical Systems LLC

St Jude Medical CRMD: CPS Valve Bypass Tool (VBT), Model 410192

Sterility-Some of the sterile pouches in which these products are packaged may not have been properly sealed during their packaging process.

FDAJun 1, 2006AZ, CA, IN +3 more• St Jude Medical CRMD

St Jude Medical CRMD: CPS Slitter, Model 410191

Sterility-Some of the sterile pouches in which these products are packaged may not have been properly sealed during their packaging process.

FDAJun 1, 2006AZ, CA, IN +3 more• St Jude Medical CRMD

St Jude Medical CRMD: CPS Implant Kit, Model 410190

Sterility-Some of the sterile pouches in which these products are packaged may not have been properly sealed during their packaging process.

FDAJun 1, 2006AZ, CA, IN +3 more• St Jude Medical CRMD

General Electric Med Systems LLC: GE Healthcare Revolution XR/d; GE Healthcare, 3000 North ...

An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath

Class IIModerate

FDAMay 31, 2006Nationwide• General Electric Med Systems LLC

General Electric Med Systems LLC: GE Healthcare Proteus XR/a General Purpose Radiographic ...

Labeling; failure to properly label per 21 CFR 1010.2 and 1010.3 -The Operator Console of the Proteus XR/a General Purpose Radiographic Systems were not properly labeled.

FDAMay 31, 2006Nationwide• General Electric Med Systems LLC

General Electric Med Systems LLC: GE Healthcare Definium 8000 Digital Radiographic Systems ...

An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath

FDAMay 31, 2006Nationwide• General Electric Med Systems LLC

General Electric Med Systems LLC: GE Proteus XR/a Radiographic System. GE Medical Systems-...

An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath

FDAMay 31, 2006Nationwide• General Electric Med Systems LLC

GE OEC Medical Systems, Inc: GE 4 inch Anterior Cervical Post, GE Part Number 1006385 ...

Weld defect- the weld between the post body and the screw was not properly formed and can fail, even when minimal force is used.

FDAMay 31, 2006Nationwide• GE OEC Medical Systems, Inc

General Electric Med Systems LLC: GE Healthcare Revolution XR/d; GE Healthcare, 3000 North ...

An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath

FDAMay 31, 2006Nationwide• General Electric Med Systems LLC

General Electric Med Systems LLC: GE Healthcare Definium 8000 Digital Radiographic Systems ...

An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath

Class IIModerate

FDAMay 31, 2006Nationwide• General Electric Med Systems LLC

General Electric Med Systems LLC: GE Proteus XR/a Radiographic System. GE Medical Systems-...

An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath

Class IIModerate

FDAMay 31, 2006Nationwide• General Electric Med Systems LLC

Electric Smokehouse Smoker (Masterbuilt) – Fire Risk (2006)

The smokers cook food slowly at lower temperatures and use wood chips to produce smoke inside the unit for flavor. Wood chips are placed inside the smoker and heated using an electric burner element to produce smoldering coals. The electric smokehouse model ESQ30B has a black powder coated outer shell with the Masterbuilt Electric Smokehouse logo on the front door. The electric smokehouse model ESQ30S has a stainless steel outer shell with the Masterbuilt Electric Smokehouse logo on the front door. The model number is located on a metal plate on the back of the unit.

CPSCMay 31, 2006Nationwide• Masterbuilt Manufacturing Inc., of Columbus Ga.

Suros Surgical Systems Inc.: ATEC Breast Biopsy and Excision System Needle Guide, 9 GA...

Lack of assurance of sterility, as package may have a seal defect (improperly sealed primary packaging).

FDAMay 25, 2006Nationwide• Suros Surgical Systems Inc.