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. 3,022 recalls have been distributed to California in the last 12 months.

56,506 total recalls
3,022 in last 12 months

Showing 98019820 of 30,923 recalls

Medical DeviceJuly 16, 2021· Teleflex Medical Europe Ltd

Recalled Item: RUSCH Endotracheal Tube oral/nasal Magill Recalled by Teleflex Medical...

The Issue: The firm received reports that the endotracheal tube cuff could be inflated...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 16, 2021· Teleflex Medical Europe Ltd

Recalled Item: RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set Recalled by Teleflex...

The Issue: The firm received reports that the endotracheal tube cuff could be inflated...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 15, 2021· Philips North America

Recalled Item: (1) Ingenia Ambition X (Product Number 781356) Recalled by Philips North...

The Issue: The sealed magnet will experience uncontrolled shutdown known as...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 15, 2021· Beckman Coulter Inc.

Recalled Item: Normand Remisol Advance Data Manager Recalled by Beckman Coulter Inc. Due to...

The Issue: There is a potential that the data management system may add additional...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 15, 2021· Cell Marque Corporation

Recalled Item: Cell Marque Antibodies Recalled by Cell Marque Corporation Due to Mouse...

The Issue: Mouse Monoclonal Antibody labelled with an incorrect expiry date of 31 Dec...

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

Class III — Low RiskOngoing
Medical DeviceJuly 14, 2021· Pentax of America Inc

Recalled Item: Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models:...

The Issue: Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 14, 2021· Pentax of America Inc

Recalled Item: Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One...

The Issue: Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 14, 2021· Ostial Corporation

Recalled Item: FLASH Ostial System Recalled by Ostial Corporation Due to Angioplasty system...

The Issue: Angioplasty system has a manufacturing issue that has the potential to...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 14, 2021· Smith & Nephew Orthopaedics Ltd. (Aurora)

Recalled Item: smith&nephew BHR SQUARE HEADED NAIL Recalled by Smith & Nephew Orthopaedics...

The Issue: The nail head may become detached during surgery.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 14, 2021· Maquet Medical Systems USA

Recalled Item: Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water...

The Issue: There is the potential for contaminated water to enter parts of the...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 13, 2021· Micro Therapeutics Inc,

Recalled Item: EV3 Pipeline Flex Embolization Device with Flex Shield Technology Recalled...

The Issue: Due to potential push wire fractures in the delivery system during use. The...

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

Class I — Serious Health HazardOngoing
Medical DeviceJuly 13, 2021· Micro Therapeutics Inc,

Recalled Item: Pipeline Flex Embolization Device Recalled by Micro Therapeutics Inc, Due to...

The Issue: Due to potential push wire fractures in the delivery system during use. The...

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

Class I — Serious Health HazardOngoing
Medical DeviceJuly 12, 2021· Siemens Medical Solutions USA, Inc.

Recalled Item: ACUSON Juniper Diagnostic Ultrasound System Recalled by Siemens Medical...

The Issue: Due to intermittent failures of the power supply in the ultrasound system...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 12, 2021· W. L. Gore & Associates Inc.

Recalled Item: Gore Molding & Occlusion Balloon Catheter Recalled by W. L. Gore &...

The Issue: Complaints received concerning Balloon Catheter leakage from the guidewire...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 12, 2021· Abbott Laboratories, Inc

Recalled Item: Alinity s System . An automated immunoassay analyzer for Recalled by Abbott...

The Issue: A design defect (hardware and software) allows liquid waste pressure to...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 12, 2021· Stanbio Laboratory, LP

Recalled Item: Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic...

The Issue: Deterioration in the stability of the reagents which has resulted in lower...

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

Class III — Low RiskOngoing
Medical DeviceJuly 12, 2021· Stanbio Laboratory, LP

Recalled Item: Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent....

The Issue: Deterioration in the stability of the reagents which has resulted in lower...

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

Class III — Low RiskOngoing
Medical DeviceJuly 12, 2021· Stanbio Laboratory, LP

Recalled Item: Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent. Recalled...

The Issue: Deterioration in the stability of the reagents which has resulted in lower...

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

Class III — Low RiskOngoing
Medical DeviceJuly 12, 2021· Stanbio Laboratory, LP

Recalled Item: Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent. Recalled by...

The Issue: Deterioration in the stability of the reagents which has resulted in lower...

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

Class III — Low RiskOngoing
Medical DeviceJuly 12, 2021· Stanbio Laboratory, LP

Recalled Item: Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in...

The Issue: Deterioration in the stability of the reagents which has resulted in lower...

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

Class III — Low RiskOngoing