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 2004120060 of 28,964 recalls

Medical DeviceJuly 27, 2016· OrthoPediatrics Corp

Recalled Item: 3.5mm Bowed Locking Compression Femur Plates Recalled by OrthoPediatrics...

The Issue: OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 26, 2016· Philips Electronics North America Corporation

Recalled Item: IntelliVue Patient Monitor Product Usage: The monitors are indicated for...

The Issue: If an affected Patient Monitor has been powered on continuously for several...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 26, 2016· Howmedica Osteonics Corp.

Recalled Item: AccuLIF PL 8-12mm x 11mm x 27mm x 8 Cage Recalled by Howmedica Osteonics...

The Issue: Since Stryker acquired the AccuLIF product in March of 2014, there have been...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 26, 2016· Howmedica Osteonics Corp.

Recalled Item: AccuLIF PL 6-9mm x 11mm x 27mm x 8 Cage Recalled by Howmedica Osteonics...

The Issue: Since Stryker acquired the AccuLIF product in March of 2014, there have been...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 26, 2016· Howmedica Osteonics Corp.

Recalled Item: AccuLIF PL 10-16mm x 11mm x 27mm x 8 Cage Recalled by Howmedica Osteonics...

The Issue: Since Stryker acquired the AccuLIF product in March of 2014, there have been...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 26, 2016· Siemens Medical Solutions USA, Inc

Recalled Item: PRIMUS Recalled by Siemens Medical Solutions USA, Inc Due to Software patch...

The Issue: Software patch installation to address several safety issues.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 26, 2016· Encore Medical, Lp

Recalled Item: Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement Recalled by...

The Issue: The outer packaging was mislabeled on the box indicating "Cobalt HV with...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 26, 2016· Siemens Medical Solutions USA, Inc

Recalled Item: ARTISTE Recalled by Siemens Medical Solutions USA, Inc Due to Software patch...

The Issue: Software patch installation to address several safety issues.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 26, 2016· Siemens Medical Solutions USA, Inc

Recalled Item: Syngo RT Therapist Recalled by Siemens Medical Solutions USA, Inc Due to...

The Issue: Software patch installation to address several safety issues.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 25, 2016· Microgenics Corporation

Recalled Item: DRI Salicylate Serum Tox Assay Recalled by Microgenics Corporation Due to...

The Issue: Some lots of DRI Salicylate Serum Tox Assay negative patient samples are...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 25, 2016· Terumo Cardiovascular Systems Corp

Recalled Item: Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled...

The Issue: Terumo Custom Cardiovascular Procedure Kits are labeled as Xcoating surface...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 22, 2016· GE OEC Medical Systems, Inc

Recalled Item: OEC 9800 Recalled by GE OEC Medical Systems, Inc Due to A firmware issue in...

The Issue: A firmware issue in the supplied LCD workstation monitor(s). Under some...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 22, 2016· GE OEC Medical Systems, Inc

Recalled Item: OEC UroView 2800 Recalled by GE OEC Medical Systems, Inc Due to A firmware...

The Issue: A firmware issue in the supplied LCD workstation monitor(s). Under some...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 21, 2016· Inovo, Inc

Recalled Item: INOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen Recalled by...

The Issue: Device can fail during operation.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 21, 2016· Smith & Nephew, Inc.

Recalled Item: RENASYS Sterile Transparent Film and all the RENASYS Dressing kits Recalled...

The Issue: Sterility seal integrity failures on the Renasys Sterile Transparent Film

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 21, 2016· Integra LifeSciences Corp.

Recalled Item: Large QWIX Compression screw Recalled by Integra LifeSciences Corp. Due to...

The Issue: Labeling on the Qwix Screw product states that it is a "compression screw"...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 20, 2016· Siemens Healthcare Diagnostics, Inc.

Recalled Item: ADVIA Chemistry XPT Recalled by Siemens Healthcare Diagnostics, Inc. Due to...

The Issue: Siemens identified an issue with the ratio equation provided on the ADVIA...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 20, 2016· Philips Medical Systems (Cleveland) Inc

Recalled Item: Ingenuity Core128 Recalled by Philips Medical Systems (Cleveland) Inc Due to...

The Issue: After upgrading to 3.6.7 software version via FCO72800643, during...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 20, 2016· Nobel Biocare Usa Llc

Recalled Item: Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Recalled by...

The Issue: Incorrect drill protocol in the Instructions for Use (IFU)

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 20, 2016· Cardinal Health

Recalled Item: BLUE IMPERVIOUS GOWN WITH THUMBHOOKS Recalled by Cardinal Health Due to Blue...

The Issue: Blue Impervious Gown with thumbhooks, X-large. All lots do not meet design...

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

Class II — Potential Health HazardOngoing