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. 1,152 recalls have been distributed to Colorado in the last 12 months.

51,434 total recalls
1,152 in last 12 months

Showing 9641–9660 of 28,964 recalls

Medical DeviceMay 19, 2021· CooperVision Inc.

Recalled Item: CLARITI 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact...

The Issue: Misaligned placement of an axis mark can cause the patient to experience...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 19, 2021· Vero Biotech, LLC

Recalled Item: GENOSYL DS Recalled by Vero Biotech, LLC Due to Reports received of NO...

The Issue: Reports received of NO measured below desired dose during transition between...

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

Class I — Serious Health HazardOngoing
Medical DeviceMay 19, 2021· Smith & Nephew, Inc.

Recalled Item: LEGION Posterior Stabilized OXINIUM Femoral Component Recalled by Smith &...

The Issue: The device components experienced a manufacturing process error that...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 19, 2021· Arrow International Inc

Recalled Item: Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm Recalled...

The Issue: Marketed without a 510K

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 19, 2021· Arrow International Inc

Recalled Item: Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr....

The Issue: Marketed without a 510K

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 19, 2021· Arrow International Inc

Recalled Item: Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm Recalled by Arrow...

The Issue: Marketed without a 510K

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 19, 2021· Arrow International Inc

Recalled Item: Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr....

The Issue: Marketed without a 510K

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 19, 2021· Bard Access Systems Inc.

Recalled Item: 5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with Recalled by Bard...

The Issue: Catheter convenience kits contain the incorrect guidewire. Kits were labeled...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 19, 2021· CooperVision Inc.

Recalled Item: FRESH DAY 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Recalled by...

The Issue: Misaligned placement of an axis mark can cause the patient to experience...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 19, 2021· Philips Medical Systems DMC GmbH

Recalled Item: DigitalDiagnost C90 High Performance. radiography and fluoroscopy system...

The Issue: Following a system restart where the Table Height 2 (TH2) is the default...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 19, 2021· Philips Medical Systems DMC GmbH

Recalled Item: DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system Recalled...

The Issue: Following a system restart where the Table Height 2 (TH2) is the default...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 19, 2021· Philips Medical Systems DMC GmbH

Recalled Item: DigitalDiagnost 4 High Performance. radiography and fluoroscopy system...

The Issue: Following a system restart where the Table Height 2 (TH2) is the default...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 19, 2021· Philips Medical Systems DMC GmbH

Recalled Item: ProxiDiagnost N90. radiography and fluoroscopy system Recalled by Philips...

The Issue: Following a system restart where the Table Height 2 (TH2) is the default...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 19, 2021· Philips Medical Systems DMC GmbH

Recalled Item: DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system...

The Issue: Following a system restart where the Table Height 2 (TH2) is the default...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 18, 2021· Stryker Spine

Recalled Item: Cortoss Bone Augmentation Material 10cc Cartridge Recalled by Stryker Spine...

The Issue: The products experienced a 12-hour excursion from the required temperature...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 18, 2021· Siemens Healthcare Diagnostics, Inc.

Recalled Item: The ADVIA Chemistry XPT Chemistry System Recalled by Siemens Healthcare...

The Issue: ADVIA Chemistry System and Software Versions (V1.4 SMN 11314625 and V1.4...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 18, 2021· Stryker Spine

Recalled Item: Cortoss Bone Augmentation Material 5cc Cartridge Recalled by Stryker Spine...

The Issue: The products experienced a 12-hour excursion from the required temperature...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 17, 2021· Smiths Medical ASD Inc.

Recalled Item: JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G...

The Issue: Specific models and lot numbers of the Jelco Hypodermic Needle-Pro Fixed...

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

Class I — Serious Health HazardOngoing
Medical DeviceMay 14, 2021· Smiths Medical ASD Inc.

Recalled Item: PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit Recalled by Smiths...

The Issue: One lot number of a specific model of ULTRAperc Percutaneous Dilation...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 14, 2021· DeRoyal Industries Inc

Recalled Item: DeRoyal Pacemaker Tray Pgybk Recalled by DeRoyal Industries Inc Due to...

The Issue: DeRoyal manufactured certain lots of surgical procedure pack products using...

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

Class I — Serious Health HazardOngoing