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. 2,652 recalls have been distributed to Colorado in the last 12 months.

51,434 total recalls
2,652 in last 12 months

Showing 1278112800 of 28,964 recalls

Medical DeviceNovember 20, 2019· Datascope Corporation

Recalled Item: Reinforced Introducer Sets Maquet 7 Fr. Recalled by Datascope Corporation...

The Issue: Potential for compromised sterility in breached pouches of specific lots of...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 20, 2019· Datascope Corporation

Recalled Item: Reinforced Introducer Sets Maquet 7.5 Fr. Recalled by Datascope Corporation...

The Issue: Potential for compromised sterility in breached pouches of specific lots of...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 19, 2019· Siemens Healthcare Diagnostics, Inc.

Recalled Item: ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP)...

The Issue: Atellica and ADVIA hsCRP calibrator accuracy has drifted away from the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 19, 2019· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Atellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator - Product...

The Issue: Atellica CH: The Atellica¿ CH High Sensitivity CReactive Protein Calibrator...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 19, 2019· Cardiac Assist, Inc

Recalled Item: TandemLife ECLS Procedure Kit - V24/A17 Recalled by Cardiac Assist, Inc Due...

The Issue: The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 19, 2019· Angiodynamics, Inc.

Recalled Item: OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KIT Recalled by...

The Issue: May result in readings outside of the expected accuracy range.

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 19, 2019· Angiodynamics, Inc.

Recalled Item: OARtrac PLUS CLINICAL DETECTOR UNIT Catalog Number: OTS-V2-Plus - Product...

The Issue: May result in readings outside of the expected accuracy range.

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 19, 2019· Angiodynamics, Inc.

Recalled Item: MICRO-PSD HDR Recalled by Angiodynamics, Inc. Due to May result in readings...

The Issue: May result in readings outside of the expected accuracy range.

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 19, 2019· Angiodynamics, Inc.

Recalled Item: MICRO-PSD Electron Recalled by Angiodynamics, Inc. Due to May result in...

The Issue: May result in readings outside of the expected accuracy range.

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 19, 2019· Angiodynamics, Inc.

Recalled Item: MICRO-PSD EXTERNAL BEAM PHOTON Recalled by Angiodynamics, Inc. Due to May...

The Issue: May result in readings outside of the expected accuracy range.

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 18, 2019· RAYSEARCH LABORATORIES AB

Recalled Item: RayStation stand-alone software treatment planning system Recalled by...

The Issue: Editing a static arc beam may unexpectedly set the MU of the beam to its...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 18, 2019· Diagnostica Stago, Inc.

Recalled Item: STA SYSTEM CONROL N + P (ref. 00678) Recalled by Diagnostica Stago, Inc. Due...

The Issue: A positive bias was confirmed to exists on the STA - Unicalibrator levels...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 18, 2019· Diagnostica Stago, Inc.

Recalled Item: STA UNICALIBRATOR (ref. 00675) Recalled by Diagnostica Stago, Inc. Due to A...

The Issue: A positive bias was confirmed to exists on the STA - Unicalibrator levels...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 18, 2019· Leica Microsystems, Inc.

Recalled Item: BOND Polymer Detection Kit Recalled by Leica Microsystems, Inc. Due to BOND...

The Issue: BOND Polymer Detection kits (DS9800) were held out of storage longer than...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 18, 2019· Boston Scientific Corporation

Recalled Item: Habib EUS RFA Recalled by Boston Scientific Corporation Due to During...

The Issue: During testing on the Habib EUS RFA device, a temperature increase was...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 18, 2019· Boston Scientific Corporation

Recalled Item: Habib EUS RFA Recalled by Boston Scientific Corporation Due to During...

The Issue: During testing on the Habib EUS RFA device, a temperature increase was...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 15, 2019· Baxter Healthcare Corporation

Recalled Item: Revaclear Capillary Dialyzer 300 Recalled by Baxter Healthcare Corporation...

The Issue: There is the potential presence of particular matter in the header caps of...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 15, 2019· Tytek Medical Inc

Recalled Item: PneumoDart Recalled by Tytek Medical Inc Due to A defect involving an...

The Issue: A defect involving an occluded needle was discovered during a training exercise.

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

Class I — Serious Health HazardOngoing
Medical DeviceNovember 15, 2019· Medtronic Navigation, Inc.-Littleton

Recalled Item: O-arm" O2 Imaging System Recalled by Medtronic Navigation, Inc.-Littleton...

The Issue: Due to a manufacturing issue affecting particular O-arm" O2 Imaging Systems,...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 15, 2019· Tosoh Smd Inc

Recalled Item: AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment...

The Issue: The AIA-2000 bar code scanners depend on the quiet zone to help identify the...

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

Class III — Low RiskOngoing