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. 2,551 recalls have been distributed to Colorado in the last 12 months.

51,434 total recalls
2,551 in last 12 months

Showing 2044120460 of 28,964 recalls

Medical DeviceMay 16, 2016· Ortho-Clinical Diagnostics

Recalled Item: enGen Laboratory Automation System Recalled by Ortho-Clinical Diagnostics...

The Issue: If the user selects the Comment or Interpretation option (in the enGEN .gsb...

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

Class III — Low RiskOngoing
Medical DeviceMay 12, 2016· CareFusion 303, Inc.

Recalled Item: Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19...

The Issue: A patient weight can be populated incorrectly under certain conditions when...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 12, 2016· Baxter Healthcare Corp

Recalled Item: COSEAL Surgical Sealant Kit Recalled by Baxter Healthcare Corp Due to...

The Issue: Potential for incomplete dissolution of the polyethylene glycol (PEG)...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 12, 2016· Baxter Healthcare Corp

Recalled Item: COSEAL Surgical Sealant Kit Recalled by Baxter Healthcare Corp Due to...

The Issue: Potential for incomplete dissolution of the polyethylene glycol (PEG)...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 12, 2016· Baxter Healthcare Corp

Recalled Item: COSEAL Surgical Sealant Kit Recalled by Baxter Healthcare Corp Due to...

The Issue: Potential for incomplete dissolution of the polyethylene glycol (PEG)...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 11, 2016· Synthes (USA) Products LLC

Recalled Item: Norian Drillable Inject 10 CC-Sterile Recalled by Synthes (USA) Products LLC...

The Issue: DePuy Synthes is initiating a voluntary medical device recall of unexpired...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 11, 2016· Siemens Healthcare Diagnostics Inc.

Recalled Item: Hettich Centrifuge Modules: StreamLAB Centrifuge Module (10372372 or...

The Issue: Premature bucket failures

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 11, 2016· Synthes (USA) Products LLC

Recalled Item: Norian Drillable Inject 5 CC-Sterile Recalled by Synthes (USA) Products LLC...

The Issue: DePuy Synthes is initiating a voluntary medical device recall of unexpired...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 11, 2016· Synthes (USA) Products LLC

Recalled Item: Norian Drillable Inject 3 CC-Sterile Recalled by Synthes (USA) Products LLC...

The Issue: DePuy Synthes is initiating a voluntary medical device recall of unexpired...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 10, 2016· CarboFix Orthopedics, Ltd.

Recalled Item: Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Recalled by...

The Issue: Firm received complaints where the Piccolo Composite Ball Tip Guide Wire...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 10, 2016· Integra LifeSciences Corp.

Recalled Item: TS Series Depth Gauge for Integra Ti6 Internal Fixation System Recalled by...

The Issue: As a result of an internal investigation of a non-conformance it has been...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 9, 2016· GE Healthcare, LLC

Recalled Item: MSK 1.5T Extreme MR Scanner Recalled by GE Healthcare, LLC Due to The gas...

The Issue: The gas venting may not occur properly. A site reported a magnet quenching...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 9, 2016· GE Healthcare, LLC

Recalled Item: GE Revolution CT The system is intended for head Recalled by GE Healthcare,...

The Issue: GEHC has become aware of a potential safety issue in the Revolution CT...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 9, 2016· GE Healthcare, LLC

Recalled Item: Optima 1.5T MR430s MR Scanner Recalled by GE Healthcare, LLC Due to The gas...

The Issue: The gas venting may not occur properly. A site reported a magnet quenching...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 9, 2016· Immuno-Mycologics, Inc

Recalled Item: Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal...

The Issue: The device was found to have bacterial contamination.

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 9, 2016· ORTHO-CLINICAL DIAGNOSTICS

Recalled Item: VITROS Immunodiagnostic Products AFP Reagent Pack Recalled by ORTHO-CLINICAL...

The Issue: Ortho Clinical Diagnostics (OCD) confirmed that specific lots of VITROS...

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

Class III — Low RiskOngoing
Medical DeviceMay 6, 2016· BEST THERATRONICS LTD.

Recalled Item: Best Theratronics cabinet x-ray systems intended for use in the Recalled by...

The Issue: It was discovered that both the new device and the predicate device failed...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 6, 2016· Leica Biosystems Richmond Inc.

Recalled Item: Ariol is an automated scanning microscope and image analysis system....

The Issue: An issue during the manufacturing process caused systems to have an...

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

Class III — Low RiskOngoing
Medical DeviceMay 6, 2016· Custom Ultrasonics, Inc.

Recalled Item: The System 83 Plus Recalled by Custom Ultrasonics, Inc. Due to To warn...

The Issue: To warn customers that Custom Ultrasonics, Inc. System 83 Plus AERs should...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 5, 2016· Ellipse A/S

Recalled Item: Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical Recalled...

The Issue: Failure to provide the required instructions specifying a procedure and...

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

Class II — Potential Health HazardOngoing