Product Recalls in California

Product recalls affecting California — including food, drugs, consumer products, medical devices, and vehicles distributed to California. RecallDetector monitors distribution data from the FDA, USDA, CPSC, and NHTSA to show you which recalls are relevant to your area. 2,948 recalls have been distributed to California in the last 12 months.

56,506 total recalls
2,948 in last 12 months

Showing 1560115620 of 30,923 recalls

Medical DeviceDecember 5, 2018· Beckman Coulter Inc.

Recalled Item: UniCel DxC 660i Recalled by Beckman Coulter Inc. Due to When racks are...

The Issue: When racks are front-loaded onto the sample presentation unit while samples...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceDecember 5, 2018· Beckman Coulter Inc.

Recalled Item: The UniCel DxI 600 and 800 Access Immunoassay Systems Recalled by Beckman...

The Issue: When racks are front-loaded onto the sample presentation unit while samples...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceDecember 5, 2018· Exactech, Inc.

Recalled Item: Equinoxe Preserve Humeral Stem Recalled by Exactech, Inc. Due to Possibility...

The Issue: Possibility that the Equinoxe Preserve Humeral Stem, 8mm, was inadvertently...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceDecember 4, 2018· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Triton Sponge System (Software) Recalled by Stryker Instruments Div. of...

The Issue: Gauss Surgical is updating the Instructions for Use (IFU) for our Triton...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class III — Low RiskOngoing
Medical DeviceDecember 4, 2018· Agfa-Gevaert, N.V.

Recalled Item: DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 Recalled by...

The Issue: After an upgrade of the software of the Overhead Tube Crane, there were...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceDecember 3, 2018· PENTAX of America Inc

Recalled Item: Pentax Medical C2 CryoBalloon Standard Focal Catheter Recalled by PENTAX of...

The Issue: Incorrect default dose and dose increments may be transmitted to the...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceDecember 3, 2018· PENTAX of America Inc

Recalled Item: Pentax Medical C2 CryoBalloon Pear Focal Catheter Recalled by PENTAX of...

The Issue: Incorrect default dose and dose increments may be transmitted to the...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceDecember 3, 2018· PENTAX of America Inc

Recalled Item: Pentax Medical C2 CryoBalloon Standard 90 degree Catheter Recalled by PENTAX...

The Issue: Incorrect default dose and dose increments may be transmitted to the...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceDecember 3, 2018· Conformis, Inc.

Recalled Item: iTotal CR Total Knee Replacement System Recalled by Conformis, Inc. Due to...

The Issue: The kits were prepared with incorrect patient ID labels and may contain...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceDecember 3, 2018· Randox Laboratories Ltd.

Recalled Item: Fructosamine Control 3 Recalled by Randox Laboratories Ltd. Due to The firm...

The Issue: The firm is conducting a Device Modification for Fructosamine Calibrator,...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceDecember 3, 2018· Randox Laboratories Ltd.

Recalled Item: Fructosamine Calibrator Recalled by Randox Laboratories Ltd. Due to The firm...

The Issue: The firm is conducting a Device Modification for Fructosamine Calibrator,...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceDecember 3, 2018· Randox Laboratories Ltd.

Recalled Item: Fructosamine Control 1 Recalled by Randox Laboratories Ltd. Due to The firm...

The Issue: The firm is conducting a Device Modification for Fructosamine Calibrator,...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceDecember 3, 2018· PENTAX of America Inc

Recalled Item: C2 CryoBalloon Controller Recalled by PENTAX of America Inc Due to The...

The Issue: The Controller does not detect overpressure in the balloon during the...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceDecember 3, 2018· Philips Medical Systems Nederlands

Recalled Item: Ingenia Elition S Recalled by Philips Medical Systems Nederlands Due to...

The Issue: During automatic tabletop movement, pressing and holding the Stop Table...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceNovember 30, 2018· GE Healthcare, LLC

Recalled Item: System Recalled by GE Healthcare, LLC Due to GE Healthcare has identified...

The Issue: GE Healthcare has identified that a small number of Nuclear Medicine systems...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceNovember 30, 2018· GE Healthcare, LLC

Recalled Item: System Recalled by GE Healthcare, LLC Due to GE Healthcare has identified...

The Issue: GE Healthcare has identified that a small number of Nuclear Medicine systems...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceNovember 30, 2018· Philips Medical Systems Nederlands

Recalled Item: Azurion lnterventional Fluoroscopic X-ray System Recalled by Philips Medical...

The Issue: Philips has discovered through customer complaints and internal testing an...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceNovember 30, 2018· Beaver Visitec

Recalled Item: BVI Visitec Soft Tip Cannula Recalled by Beaver Visitec Due to Certain lots...

The Issue: Certain lots are missing a protective sheath component over the silicone...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceNovember 30, 2018· Siemens Medical Solutions USA, Inc.

Recalled Item: Siemens Biograph Horizon PET/CT System Recalled by Siemens Medical Solutions...

The Issue: Improper design or specifications.

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceNovember 30, 2018· Tosoh Bioscience Inc

Recalled Item: ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing