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. 3,068 recalls have been distributed to California in the last 12 months.

56,506 total recalls
3,068 in last 12 months

Showing 31413160 of 30,923 recalls

Medical DeviceSeptember 17, 2024· Topcon Medical Systems, Inc.

Recalled Item: The IMAGEnet 6 Ophthalmic Data System is a software program Recalled by...

The Issue: The overlay of visual field test locations on a probability map, as...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 17, 2024· Zimmer, Inc.

Recalled Item: Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use...

The Issue: A Gen 5 tail piece was assembled to a Gen 4 Finished Device, resulting in a...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 17, 2024· Canon Medical System, USA, INC.

Recalled Item: Cartesion Prime Recalled by Canon Medical System, USA, INC. Due to When...

The Issue: When PET-CT system is executing reconstruction, if PET acquisition for...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 17, 2024· Mckesson Medical-Surgical Inc. Corporate Office

Recalled Item: Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing...

The Issue: The Quantimetrix Dipper Urinalysis Dipstick control was shipped without the...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 16, 2024· Percussionaire Corporation

Recalled Item: Phasitron5 Breathing Circuit (P5-10 Recalled by Percussionaire Corporation...

The Issue: As a result of product complaints, breathing circuits are experiencing...

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

Class I — Serious Health HazardOngoing
Medical DeviceSeptember 16, 2024· Ambu Inc.

Recalled Item: Ambu¿ VivaSight 2 DLT Endobronchial tube Recalled by Ambu Inc. Due to Ambu...

The Issue: Ambu has received complaints on Ambu¿ VivaSight 2 DLTs regarding hyper...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 13, 2024· Olympus Corporation of the Americas

Recalled Item: Olympus Cystoscope Outer Sheath Recalled by Olympus Corporation of the...

The Issue: Product being removed due to incompatibility when used in conjunction with a...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 13, 2024· Olympus Corporation of the Americas

Recalled Item: Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog...

The Issue: Olympus is removing the statement of compatibility with a GreenLight Laser...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 13, 2024· DRG International, Inc.

Recalled Item: 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for Recalled by...

The Issue: The High and Low Control acceptance ranges in the Certificate of Analysis...

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

Class III — Low RiskOngoing
Medical DeviceSeptember 13, 2024· Olympus Corporation of the Americas

Recalled Item: EZDilate Wire Guided Balloon- Indicated for use in adult and Recalled by...

The Issue: Mislabeled Glo Cath Label (attached to the device) states: 11 mm, 12 mm, 13...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 13, 2024· Integra LifeSciences Corp.

Recalled Item: MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing...

The Issue: There is a potential for pinholes in the applicator pouch film which creates...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 13, 2024· Zyno Medical LLC

Recalled Item: Z-800 Infusion System Recalled by Zyno Medical LLC Due to There is a defect...

The Issue: There is a defect in the air-in-line software algorithm.

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

Class I — Serious Health HazardOngoing
Medical DeviceSeptember 12, 2024· Abbott Molecular, Inc.

Recalled Item: Abbott Alinity m HPV AMP Kit Recalled by Abbott Molecular, Inc. Due to...

The Issue: Abbott has identified an increase of incidences regarding Error Code (EC)...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 12, 2024· Abbott Molecular, Inc.

Recalled Item: Abbott Alinity m STI AMP Kit Recalled by Abbott Molecular, Inc. Due to...

The Issue: Abbott has identified an increase of incidences regarding Error Code (EC)...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 12, 2024· Baxter Healthcare Corporation

Recalled Item: Welch Allyn Life2000 Ventilation System Recalled by Baxter Healthcare...

The Issue: The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if...

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

Class I — Serious Health HazardOngoing
Medical DeviceSeptember 12, 2024· Becton Dickinson & Co.

Recalled Item: BD Synapsys Informatics Solution with software versions: 4.20 Recalled by...

The Issue: Synapsys software versions 4.20, 4.30, 5.10, 5.20, or 5.30 and utilizing the...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 11, 2024· Olympus Corporation of the Americas

Recalled Item: Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access...

The Issue: Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 11, 2024· Medtronic Neuromodulation

Recalled Item: SynchroMed II Infusion Pump. Product Number: 8637-20 Recalled by Medtronic...

The Issue: Potential for error and inability to interrogate pump due to data corruption...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 11, 2024· Waldemar Link GmbH & Co. KG (Corp. Hq.)

Recalled Item: LINK Universal Handle Recalled by Waldemar Link GmbH & Co. KG (Corp. Hq.)...

The Issue: Some lots of the LINK Universal Handle, with quick coupling, Stainless...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 9, 2024· Atrium Medical Corporation

Recalled Item: iCast Covered Stent Recalled by Atrium Medical Corporation Due to There is...

The Issue: There is an error in the Unique Device Identifier (UDI) printed on the...

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

Class II — Potential Health HazardOngoing