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. 2,509 recalls have been distributed to Colorado in the last 12 months.

51,434 total recalls
2,509 in last 12 months

Showing 2856128580 of 51,434 recalls

DrugSeptember 15, 2017· Gadget Island, Inc

Recalled Item: PapaZen 3300 capsule Recalled by Gadget Island, Inc Due to Undeclared Active

The Issue: Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class I — Serious Health HazardOngoing
Refund
DrugSeptember 15, 2017· Gadget Island, Inc

Recalled Item: RHINO 7 Platinum 5000 Recalled by Gadget Island, Inc Due to Undeclared Active

The Issue: Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class I — Serious Health HazardOngoing
Refund
Medical DeviceSeptember 15, 2017· Encore Medical, Lp

Recalled Item: EMPOWR PS KNEE(TM) e+ Recalled by Encore Medical, Lp Due to It was reported...

The Issue: It was reported that an implant labeled as 343-13-708 was packaged with...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 15, 2017· Encore Medical, Lp

Recalled Item: EMPOWR PS KNEE(TM) e+ Recalled by Encore Medical, Lp Due to It was reported...

The Issue: It was reported that an implant labeled as 343-13-708 was packaged with...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 15, 2017· HILL-ROM MANUFACTURING, INC.

Recalled Item: Monarch Airway Clearance System Recalled by HILL-ROM MANUFACTURING, INC. Due...

The Issue: Monarch Electromagnetic Interference (EMI) may disrupt the operation of...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 14, 2017· C.R. Bard, Inc.

Recalled Item: Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box Recalled by...

The Issue: Several instances of a catheter caught in the sterile barrier seal and in...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 14, 2017· C.R. Bard, Inc.

Recalled Item: Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box...

The Issue: Several instances of a catheter caught in the sterile barrier seal and in...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 14, 2017· C.R. Bard, Inc.

Recalled Item: HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box...

The Issue: Several instances of a catheter caught in the sterile barrier seal and in...

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

Class II — Potential Health HazardOngoing
DrugSeptember 14, 2017· Medisca, Inc.

Recalled Item: Aminocaproic Acid Recalled by Medisca, Inc. Due to CGMP Deviations: Product...

The Issue: CGMP Deviations: Product manufactured for Industrial Use but was labeled...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugSeptember 13, 2017· Vi-Jon, Inc.

Recalled Item: Equate Beauty Clarifying Face Daily Moisturizer 4 fl. oz. (118 Recalled by...

The Issue: Failed Stability Specifications

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class III — Low RiskOngoing
Refund
DrugSeptember 13, 2017· Amgen, Inc.

Recalled Item: Procrit (epoetin alfa) Recalled by Amgen, Inc. Due to Presence of...

The Issue: Presence of particulate matter: glass flakes identified as lamellae observed...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
Medical DeviceSeptember 13, 2017· Zimmer Biomet, Inc.

Recalled Item: Phoenix Antegrade Femoral Nail Trochanteric and Piriformis fossa Recalled by...

The Issue: Fracture of the bolt connecting the insertion guide to the intramedullary...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 13, 2017· Zimmer Biomet, Inc.

Recalled Item: 979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument....

The Issue: Fracture of the bolt connecting the insertion guide to the intramedullary...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 13, 2017· Zimmer Biomet, Inc.

Recalled Item: 14-442000S Antegrade Femoral Nail Instrument Kit Recalled by Zimmer Biomet,...

The Issue: Fracture of the bolt connecting the insertion guide to the intramedullary...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 12, 2017· St. Jude Medical, Inc.

Recalled Item: Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Recalled...

The Issue: Analysis of the difference between the actual device longevity and the...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 12, 2017· St. Jude Medical, Inc.

Recalled Item: Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse...

The Issue: Analysis of the difference between the actual device longevity and the...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 12, 2017· Toshiba American Medical Systems Inc

Recalled Item: Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is...

The Issue: During an examination images were displayed on the live monitor,but the...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 12, 2017· Zoll Manufacturing Corp.

Recalled Item: LifeVest Wearable Defibrillator Model 4000 Recalled by Zoll Manufacturing...

The Issue: Incorrect service code for properly catching critical defects during...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 12, 2017· Abbott Point Of Care Inc.

Recalled Item: i-STAT DE handheld data processing module for clinical use Recalled by...

The Issue: Issues resulting from upgrade to software version 2.8: (1) Location,...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 12, 2017· St. Jude Medical, Inc.

Recalled Item: Proclaim DRG Implantable Pulse Generator Model 3664 Recalled by St. Jude...

The Issue: Analysis of the difference between the actual device longevity and the...

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

Class II — Potential Health HazardOngoing