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. 2,723 recalls have been distributed to Colorado in the last 12 months.

51,434 total recalls
2,723 in last 12 months

Showing 24612480 of 28,964 recalls

Medical DeviceDecember 12, 2024· Abiomed, Inc.

Recalled Item: Impella RP with SmartAssist Recalled by Abiomed, Inc. Due to Optical Sensors...

The Issue: Optical Sensors have been damaged due to physical interaction between the...

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

Class I — Serious Health HazardOngoing
Medical DeviceDecember 12, 2024· Boston Scientific Corporation

Recalled Item: ALTRUA 2 DR Pacemaker Recalled by Boston Scientific Corporation Due to A...

The Issue: A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built...

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

Class I — Serious Health HazardOngoing
Medical DeviceDecember 11, 2024· HF Acquisition Co LLC

Recalled Item: Biological Recalled by HF Acquisition Co LLC Due to Spore test strip...

The Issue: Spore test strip monitoring system, designed for routine monitoring of...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 11, 2024· Nuwellis Inc

Recalled Item: nuwellis AquaFlexFlow UF 500 Plus Recalled by Nuwellis Inc Due to The...

The Issue: The AquaFlexFlow UF 500 Plus extracorporeal blood circuit used with the...

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

Class I — Serious Health HazardOngoing
Medical DeviceDecember 10, 2024· ev3 Inc

Recalled Item: Medtronic NanoCross Elite PTA catheter Recalled by ev3 Inc Due to There is...

The Issue: There is the potential for in-vivo balloon deflation issues, including...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 10, 2024· Mercury Enterprises, Inc. dba Mercury Medical

Recalled Item: Neo-Tee T-Piece Resuscitator Recalled by Mercury Enterprises, Inc. dba...

The Issue: Gas powered emergency resuscitator has a circuit flow controller...

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

Class I — Serious Health HazardOngoing
Medical DeviceDecember 10, 2024· Encore Medical, LP

Recalled Item: EMPOWR 3D Knee Tibial Insert Recalled by Encore Medical, LP Due to Knee...

The Issue: Knee insert package may contain an acetabular system, which may cause...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 9, 2024· Maquet Cardiovascular, LLC

Recalled Item: VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers:...

The Issue: Potential for two issues: 1. Bent or detached heater wire; 2. Silicone...

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

Class I — Serious Health HazardOngoing
Medical DeviceDecember 9, 2024· Maquet Cardiovascular, LLC

Recalled Item: Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model...

The Issue: Potential for two issues: 1. Bent or detached heater wire; 2. Silicone...

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

Class I — Serious Health HazardOngoing
Medical DeviceDecember 6, 2024· DDS Lab

Recalled Item: Temporary Titanium Abutments Recalled by DDS Lab Due to Certain definitive...

The Issue: Certain definitive dental implant restoration cases may have included a...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 6, 2024· GE Medical Systems, LLC

Recalled Item: Portrait Core Services Recalled by GE Medical Systems, LLC Due to There is a...

The Issue: There is a software issue that can result in the loss of patient monitoring...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 5, 2024· QUIDEL ORTHO

Recalled Item: Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry...

The Issue: Hemoglobin interference may occur at concentrations lower than the claimed...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 5, 2024· QUIDEL ORTHO

Recalled Item: Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry...

The Issue: Hemoglobin interference may occur at concentrations lower than the claimed...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 5, 2024· Fresenius Medical Care Holdings, Inc.

Recalled Item: Dialyzer Optiflux 160NRe Recalled by Fresenius Medical Care Holdings, Inc....

The Issue: Potential for internal blood leaks due to cracked polyurethane

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 5, 2024· Waldemar Link GmbH & Co. KG (Mfg Site)

Recalled Item: LINK MP Reconstruction System Neck Segment (with suture holes Recalled by...

The Issue: Error on the main label and the patient label. The labels indicate a size...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 4, 2024· Medtronic Navigation, Inc.

Recalled Item: Medtronic PIN Recalled by Medtronic Navigation, Inc. Due to Due to an...

The Issue: Due to an increase in complaint that the percutaneous pin would not fit into...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 4, 2024· B. Braun Medical, Inc.

Recalled Item: Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of...

The Issue: Incorrect catheter connector within the kit resulting in inability to...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 3, 2024· Medicrea International

Recalled Item: UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002...

The Issue: Due to software anomalies that may impact on rod planning specifically,...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 3, 2024· Sklar Instruments

Recalled Item: ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU...

The Issue: Reports of various packaging issues that may result in a breach of the...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 3, 2024· Sklar Instruments

Recalled Item: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE Recalled...

The Issue: Reports of various packaging issues that may result in a breach of the...

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

Class II — Potential Health HazardOngoing