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 2090120920 of 28,964 recalls

Medical DeviceMarch 8, 2016· Pelton & Crane / Marus / DCI Equipment / KaVo

Recalled Item: Helios HL3T and HLT Track Mounted Dental Lights Product Usage: Recalled by...

The Issue: The firm received two customer complaints local Pelton & Crane distributors...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 8, 2016· ICU Medical, Inc.

Recalled Item: Diana Automated Compounding System Recalled by ICU Medical, Inc. Due to ICU...

The Issue: ICU Medical Inc. has received a report of compounded volumes not meeting the...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 8, 2016· ICU Medical, Inc.

Recalled Item: Diana Automated Compounding System Recalled by ICU Medical, Inc. Due to ICU...

The Issue: ICU Medical Inc. has received a report of compounded volumes not meeting the...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 8, 2016· ICU Medical, Inc.

Recalled Item: Diana Automated Compounding System Recalled by ICU Medical, Inc. Due to ICU...

The Issue: ICU Medical Inc. has received a report of compounded volumes not meeting the...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 7, 2016· Siemens Healthcare Diagnostics, Inc.

Recalled Item: ADVIA Chemistry Triglyceride_2 Recalled by Siemens Healthcare Diagnostics,...

The Issue: Siemens Healthcare Diagnostics has confirmed the ADVIA Chemistry...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 7, 2016· MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK

Recalled Item: VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear...

The Issue: In rare cases the VERO/MHI-TM2000 Operator Console could set an incorrect...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 7, 2016· Roche Diagnostics Operations, Inc.

Recalled Item: Estradiol III Recalled by Roche Diagnostics Operations, Inc. Due to Due to...

The Issue: Due to the risk of a recently identified cross reactivity, the Elecsys...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 7, 2016· Integra LifeSciences Corp.

Recalled Item: Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments...

The Issue: Reports relating to unintended patient or operator burns or operator...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 7, 2016· Integra LifeSciences Corp.

Recalled Item: Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments...

The Issue: Reports relating to unintended patient or operator burns or operator...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 7, 2016· Roche Diagnostics Operations, Inc.

Recalled Item: Estradiol II Elecsys and cobas e analyzers 190 Recalled by Roche Diagnostics...

The Issue: Due to the risk of a recently identified cross reactivity, the Elecsys...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 4, 2016· Philips Medical Systems (Cleveland) Inc

Recalled Item: Extended Brilliance Workspace NM Special Nuclear medicine image display and...

The Issue: The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 4, 2016· Implant Direct Sybron Manufacturing, LLC

Recalled Item: The Spectra-System Dental Implant 2008 system is comprised of dental...

The Issue: Implant Direct Sybron Manufacturing, LLC is recalling GoDirect Implants...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 4, 2016· Philips Medical Systems (Cleveland) Inc

Recalled Item: IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application Recalled by...

The Issue: The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 4, 2016· C.R. Bard, Inc.

Recalled Item: BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management...

The Issue: Complaints were received of restricted/inaccurate flow rate.

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 4, 2016· Vascular Solutions, Inc.

Recalled Item: Guardian II Hemostasis Valve Recalled by Vascular Solutions, Inc. Due to...

The Issue: Vascular Solutions became aware of a potential problem with the click...

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

Class I — Serious Health HazardOngoing
Medical DeviceMarch 4, 2016· Philips Medical Systems (Cleveland) Inc

Recalled Item: Extended Brilliance Workspace NM Nuclear medicine image display and...

The Issue: The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 3, 2016· ArthroCare Corporation

Recalled Item: TOPAZ MicroDebrider 0.8 mm Recalled by ArthroCare Corporation Due to During...

The Issue: During functional testing of devices after real time aging, it was...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 3, 2016· Covidien LLC

Recalled Item: Curity X-Ray Detectable Laparotomy Sponges Recalled by Covidien LLC Due to...

The Issue: Compromised sterility due to breach of barrier

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 3, 2016· Covidien LLC

Recalled Item: Kerlix X-Ray Detectable Laparotomy Sponges Recalled by Covidien LLC Due to...

The Issue: Compromised sterility due to breach of barrier

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 3, 2016· Covidien LLC

Recalled Item: Curity X-Ray Detectable Laparotomy Sponges Recalled by Covidien LLC Due to...

The Issue: Compromised sterility due to breach of barrier

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

Class II — Potential Health HazardOngoing