Product Recalls in Colorado

Product recalls affecting Colorado — including food, drugs, consumer products, medical devices, and vehicles distributed to Colorado. RecallDetector monitors distribution data from the FDA, USDA, CPSC, and NHTSA to show you which recalls are relevant to your area. 2,684 recalls have been distributed to Colorado in the last 12 months.

51,434 total recalls
2,684 in last 12 months

Showing 76217640 of 28,964 recalls

Medical DeviceSeptember 20, 2022· Medtronic MiniMed

Recalled Item: Insulin Pump/Model: MiniMed 630G/ MMT-1715 Recalled by Medtronic MiniMed Due...

The Issue: Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 20, 2022· Intuitive Surgical, Inc.

Recalled Item: da Vinci X (IS4200) and Xi (IS4000) systems Recalled by Intuitive Surgical,...

The Issue: Inadvertent energy delivery from surgical system instrument if 1) Force...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 20, 2022· Angiodynamics, Inc.

Recalled Item: Vortex MP Port Titanium Low Profile Implanted Port with 5F Recalled by...

The Issue: Printed Instructions for Use (IFU) not shipped with device. The Instructions...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 20, 2022· Siemens Medical Solutions USA, Inc

Recalled Item: ARTIS pheno Recalled by Siemens Medical Solutions USA, Inc Due to Siemens...

The Issue: Siemens has become aware of three potential software issues with ARTIS pheno...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 19, 2022· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Atellica CH Lithium (Li) Recalled by Siemens Healthcare Diagnostics, Inc....

The Issue: Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 19, 2022· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Atellica CH Lithium_2 (LITH_2) Recalled by Siemens Healthcare Diagnostics,...

The Issue: Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 16, 2022· Fresenius Kabi USA, LLC

Recalled Item: LVP software of the Ivenix Infusion System (IIS) Recalled by Fresenius Kabi...

The Issue: Retroactively reported correction from 2022: A software defect may cause an...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 16, 2022· International Medical Industries, Inc.

Recalled Item: Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400 Recalled by...

The Issue: Blister package had an unsealed edge compromising sterility.

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 16, 2022· Olympus Corporation of the Americas

Recalled Item: Berkeley VC-10 Vacuum Curettage System Recalled by Olympus Corporation of...

The Issue: Update to the Instruction for Use (IFU): Olympus is adding a new warning...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 15, 2022· Medical Action Industries, Inc. 306

Recalled Item: B. Braun CARESITE Port Access Kit w/Tegaderm Recalled by Medical Action...

The Issue: The kits were incorrectly labeled with an extended expiration date of...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 15, 2022· B. Braun Medical, Inc.

Recalled Item: CARESITE SMALLBORE EXT SET T-PORT 5 IN. Recalled by B. Braun Medical, Inc....

The Issue: The extension set has a high probability of potential failure which could...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 15, 2022· B. Braun Medical, Inc.

Recalled Item: ULTRASITE US04TL Smallbore T-Port Extension Set Recalled by B. Braun...

The Issue: The extension set has a high probability of failure which could lead to...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 15, 2022· Becton Dickinson & Company

Recalled Item: BD Vacutainer Tube Sodium Fluoride: 100 mg Recalled by Becton Dickinson &...

The Issue: The affected product contains isobutylene which has recently demonstrated...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 15, 2022· B. Braun Medical, Inc.

Recalled Item: Extension Set Recalled by B. Braun Medical, Inc. Due to The extension set...

The Issue: The extension set has a high probability of failure which could lead to...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 14, 2022· Avanos Medical, Inc.

Recalled Item: Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male...

The Issue: Sterile extension sets were distributed without an expiration date

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 14, 2022· Luminex Corporation

Recalled Item: ARIES SARS-CoV-2 Assay Recalled by Luminex Corporation Due to A part defect...

The Issue: A part defect with the wash 1 syringe of an SARS-CoV-2 assay could lead to...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 14, 2022· ARROW INTERNATIONAL Inc.

Recalled Item: ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit...

The Issue: Mislabeling: the corrugate label, lidstock, banner card, and peel sticker...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 14, 2022· Baxter Healthcare Corporation

Recalled Item: Prismaflex HF20 Set (product code 109841). For use in providing Recalled by...

The Issue: Within the current Prismaflex set IFU (instructions for use), there is a...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 14, 2022· Baxter Healthcare Corporation

Recalled Item: Prismaflex ST Set: ST60 (product code 107643) Recalled by Baxter Healthcare...

The Issue: Within the current Prismaflex set IFU (instructions for use), there is a...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 14, 2022· Baxter Healthcare Corporation

Recalled Item: Prismaflex M Set: M60 (product code 106696) Recalled by Baxter Healthcare...

The Issue: Within the current Prismaflex set IFU (instructions for use), there is a...

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

Class II — Potential Health HazardOngoing