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 98219840 of 30,923 recalls

Medical DeviceJuly 9, 2021· Copan Italia

Recalled Item: COPAN FLOQSwabs Recalled by Copan Italia Due to A sterility assurance level...

The Issue: A sterility assurance level of 10-6 cannot be guaranteed due to intentional...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 9, 2021· PROCEPT BIOROBOTICS CORPORATION

Recalled Item: AQUABEAM Handpiece Recalled by PROCEPT BIOROBOTICS CORPORATION Due to Scope...

The Issue: Scope tube tip may detach from the telescoping tube, which is attached to a...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 9, 2021· Ortho8, Inc.

Recalled Item: CIRCUL8 LUXE DVT PREVENTION DEVICE Recalled by Ortho8, Inc. Due to CIRCUL8...

The Issue: CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 9, 2021· Ortho8, Inc.

Recalled Item: EVEXIA LUXE DVT PREVENTION DEVICE Recalled by Ortho8, Inc. Due to EVEXIA...

The Issue: EVEXIA LUXE DVT PREVENTION DEVICE is marketed without FDA clearance

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 9, 2021· Edwards Lifesciences, LLC

Recalled Item: Edwards PediaSat Oximetry Catheter Set Recalled by Edwards Lifesciences, LLC...

The Issue: There is a potential for internal leaks within catheters.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 9, 2021· Edwards Lifesciences, LLC

Recalled Item: Edwards PediaSat Oximetry Catheter Set Recalled by Edwards Lifesciences, LLC...

The Issue: There is a potential for internal leaks within catheters.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 9, 2021· Edwards Lifesciences, LLC

Recalled Item: Edwards PediaSat Oximetry Catheter Kit Recalled by Edwards Lifesciences, LLC...

The Issue: There is a potential for internal leaks within catheters.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 9, 2021· Edwards Lifesciences, LLC

Recalled Item: Edwards PediaSat Oximetry Catheter Kit Recalled by Edwards Lifesciences, LLC...

The Issue: There is a potential for internal leaks within catheters.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 9, 2021· Edwards Lifesciences, LLC

Recalled Item: Edwards PediaSat Oximetry Catheter Set Recalled by Edwards Lifesciences, LLC...

The Issue: There is a potential for internal leaks within catheters.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 9, 2021· Edwards Lifesciences, LLC

Recalled Item: Edwards PediaSat Oximetry Catheter Kit Recalled by Edwards Lifesciences, LLC...

The Issue: There is a potential for internal leaks within catheters.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 8, 2021· Argon Medical Devices, Inc

Recalled Item: Scorpion Portal Vein Access Set - Product Usage: used to Recalled by Argon...

The Issue: As a result of design changes, sheaths have exhibited cracking/breaking at...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 8, 2021· Carl Zeiss Meditec, Inc.

Recalled Item: Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX Recalled...

The Issue: Due to failure to acquire pre-market clearance for its high resolution...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 8, 2021· Sunrise Medical (US) LLC

Recalled Item: Zippie Voyage Recalled by Sunrise Medical (US) LLC Due to The seating system...

The Issue: The seating system unexpectedly detached, which resulted in the seating...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 8, 2021· Sunrise Medical (US) LLC

Recalled Item: Zippie Voyage Recalled by Sunrise Medical (US) LLC Due to The seating system...

The Issue: The seating system unexpectedly detached, which resulted in the seating...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 7, 2021· Baxter Healthcare Corporation

Recalled Item: Dose IQ Safety Software used with Spectrum IQ Infusion Pump Recalled by...

The Issue: Software issue: The defect creates a mismatch between linked drug...

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

Class I — Serious Health HazardOngoing
Medical DeviceJuly 6, 2021· Siemens Healthcare Diagnostics, Inc

Recalled Item: Atellica IM BR 27.29 (BR) Assay 250 Test Kit ()- Recalled by Siemens...

The Issue: Product does not meet the Instructions for Use (IFU) claimed Pack...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 6, 2021· Siemens Healthcare Diagnostics, Inc

Recalled Item: Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in Recalled by Siemens...

The Issue: Product does not meet the Instructions for Use (IFU) claimed Pack...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 6, 2021· Siemens Healthcare Diagnostics, Inc

Recalled Item: Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in Recalled by Siemens...

The Issue: Product does not meet the Instructions for Use (IFU) claimed Pack...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 6, 2021· Advance Dx, Inc.

Recalled Item: Advance Dx 100 Blood Collection Card Quantity 25 Recalled by Advance Dx,...

The Issue: Due to high glucose test results when using the blood collection cards.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 5, 2021· Zeltiq Aesthetics, Inc

Recalled Item: CoolSculpting Elite System The CoolSculpting System SW release 2.0 Recalled...

The Issue: An incorrect error messaging system that could potentially lead to: 1)...

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

Class II — Potential Health HazardOngoing