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 79217940 of 28,964 recalls

Medical DeviceJune 29, 2022· Biosense Webster, Inc.

Recalled Item: CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath Recalled by Biosense...

The Issue: Outside packaging for a device indicated for introducing cardiovascular...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 29, 2022· Trinity Sterile, Inc.

Recalled Item: Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708...

The Issue: Kits mislabeled as latex-free, the packaging for component 94-7002...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 29, 2022· Trinity Sterile, Inc.

Recalled Item: Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Recalled by...

The Issue: Kits mislabeled as latex-free, the packaging for component 94-7002...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 29, 2022· Trinity Sterile, Inc.

Recalled Item: Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Recalled by Trinity...

The Issue: Kits mislabeled as latex-free, the packaging for component 94-7002...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 29, 2022· Trinity Sterile, Inc.

Recalled Item: Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Recalled by Trinity...

The Issue: Kits mislabeled as latex-free, the packaging for component 94-7002...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 29, 2022· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: MEDLINE MICRO-KILL GERMICIDAL BLEACH WIPES Recalled by MEDLINE INDUSTRIES,...

The Issue: stability failure

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 29, 2022· DePuy Orthopaedics, Inc.

Recalled Item: ATTUNE Measured Sizing and Rotation Guide-to size the femur and Recalled by...

The Issue: Manufactured with a Galvanized High Carbon Steel spring instead of the...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 29, 2022· SONEX HEALTH LLC

Recalled Item: SX-One MicroKnife Recalled by SONEX HEALTH LLC Due to Potential of dull blade

The Issue: Potential of dull blade

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 28, 2022· Heartware, Inc.

Recalled Item: HeartWare Ventricular Assist Device (HVAD) System Batteries Recalled by...

The Issue: Battery performance issues. Battery electrical faults render it unable to...

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

Class I — Serious Health HazardOngoing
Medical DeviceJune 28, 2022· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use Recalled by...

The Issue: Falsely Elevated Atellica CH Microalbumin_2 (¿ALB_2) Results due to Reagent...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 27, 2022· ICU Medical, Inc.

Recalled Item: Product Description/Item: ChemoLock Bag Spike Recalled by ICU Medical, Inc....

The Issue: Ports have a potential for unintended disconnection, inability to connect to...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 27, 2022· ICU Medical, Inc.

Recalled Item: Product Description/Item: ChemoLock Vial Spike Recalled by ICU Medical, Inc....

The Issue: Ports have a potential for unintended disconnection, inability to connect to...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 27, 2022· Hamilton Medical AG

Recalled Item: HAMILTON-C6 Intensive Care Ventilator Recalled by Hamilton Medical AG Due to...

The Issue: Ventilator status indicator board can become loose, which could lead to...

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

Class I — Serious Health HazardOngoing
Medical DeviceJune 27, 2022· Davol, Inc.

Recalled Item: X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation...

The Issue: The device may potentially cause a fire, leading to a safety risk.

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 27, 2022· Smith & Nephew, Inc.

Recalled Item: (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right Recalled by Smith &...

The Issue: The product was mispackaged (swapped). The devices within the inner tray...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 24, 2022· Alere San Diego, Inc.

Recalled Item: The Cholestech LDX¿ System combines enzymatic methodology and solidphase...

The Issue: Cholesterol test cassettes package insert is to be updated with new...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 24, 2022· Neotract Inc

Recalled Item: UroLift System Recalled by Neotract Inc Due to There is the potential that...

The Issue: There is the potential that during implant deployment, the device may not...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 24, 2022· Medtronic Inc

Recalled Item: Medline Sprinter OTW Recalled by Medtronic Inc Due to Luer has balloon...

The Issue: Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 24, 2022· Stryker Instruments

Recalled Item: Stryker 2.3mm Tapered Router Recalled by Stryker Instruments Due to There is...

The Issue: There is a potential for the core diameter to be undersized, which may lead...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 24, 2022· Zeiss, Carl Inc

Recalled Item: ZEISS Axio Observer 5 microscope Recalled by Zeiss, Carl Inc Due to An...

The Issue: An incorrect Unique Device Identification (UDI) label was installed on some...

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

Class III — Low RiskOngoing