Product Recalls in Wisconsin

Product recalls affecting Wisconsin — including food, drugs, consumer products, medical devices, and vehicles distributed to Wisconsin. RecallDetector monitors distribution data from the FDA, USDA, CPSC, and NHTSA to show you which recalls are relevant to your area. 2,629 recalls have been distributed to Wisconsin in the last 12 months.

52,482 total recalls
2,629 in last 12 months

Showing 1470114720 of 28,744 recalls

Medical DeviceJanuary 22, 2019· AtriCure, Inc.

Recalled Item: COBRA FUSION 150 Ablation System Recalled by AtriCure, Inc. Due to There is...

The Issue: There is a potential for patients undergoing ablation to experience an...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 22, 2019· AtriCure, Inc.

Recalled Item: COBRA FUSION 50 Recalled by AtriCure, Inc. Due to There is a potential for...

The Issue: There is a potential for patients undergoing ablation to experience an...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 19, 2019· GE Healthcare, LLC

Recalled Item: Revolution CT scanners Product Usage: The system is intended for head...

The Issue: Additional low dose radiation exposure.

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 18, 2019· Bellus Medical

Recalled Item: SKINFUSE Resuce Calming Complex Kit containing: SKINFUSE LIFT HG - Recalled...

The Issue: Cosmetic Kit was packaged with a mislabel medical product.

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 17, 2019· CryoLife, Inc.

Recalled Item: On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: Recalled by...

The Issue: On-X Valve was mislabeled with the incorrect serial number.

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 16, 2019· Polymer Technology Systems, Inc.

Recalled Item: CHOL+HDL+GLU test strips Recalled by Polymer Technology Systems, Inc. Due to...

The Issue: Some lots of test strips do not fit tightly into the optical block, and may...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 16, 2019· Polymer Technology Systems, Inc.

Recalled Item: Lipid Panel test strips (as a component of smart bundles) Recalled by...

The Issue: Some lots of test strips do not fit tightly into the optical block, and may...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 16, 2019· Polymer Technology Systems, Inc.

Recalled Item: Lipid Panel test strips Recalled by Polymer Technology Systems, Inc. Due to...

The Issue: Some lots of test strips do not fit tightly into the optical block, and may...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 16, 2019· Edwards Lifesciences, LLC

Recalled Item: Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a...

The Issue: Edwards Lifesciences has received a limited number of customer reports...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 15, 2019· Westmed, Inc.

Recalled Item: Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask Recalled by...

The Issue: A repair was made to an adapter mold resulting in parts being produced with...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 15, 2019· Westmed, Inc.

Recalled Item: Neo-Vent Infant T-Piece Resuscitation Circuit Recalled by Westmed, Inc. Due...

The Issue: A repair was made to an adapter mold resulting in parts being produced with...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 15, 2019· Westmed, Inc.

Recalled Item: Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask Recalled by...

The Issue: A repair was made to an adapter mold resulting in parts being produced with...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 15, 2019· Miami Device Solutions, LLC.

Recalled Item: Proximal Humerus Plate Recalled by Miami Device Solutions, LLC. Due to Right...

The Issue: Right Proximal Humerus Plates. Product component parts MDS130108R, may be...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 15, 2019· Fujifilm Medical Systems U.S.A., Inc.

Recalled Item: Fujifilm FDR Go PLUS Recalled by Fujifilm Medical Systems U.S.A., Inc. Due...

The Issue: FUJIFILM Medical Systems U.S.A., Inc., Modality Systems became aware of the...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 14, 2019· Teleflex Medical

Recalled Item: RUSCH Urinary Drainage bag Recalled by Teleflex Medical Due to The device...

The Issue: The device labels are not UDI compliant. The missing UDI compliance...

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

Class III — Low RiskOngoing
Medical DeviceJanuary 14, 2019· Teleflex Medical

Recalled Item: RUSCH CARE Premium Drain bag Recalled by Teleflex Medical Due to The device...

The Issue: The device labels are not UDI compliant. The missing UDI compliance...

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

Class III — Low RiskOngoing
Medical DeviceJanuary 14, 2019· Arthrex, Inc.

Recalled Item: Arthrex Burr Recalled by Arthrex, Inc. Due to Devices may generate excessive...

The Issue: Devices may generate excessive heat during use.

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 14, 2019· Shimadzu Medical Systems Usa Com

Recalled Item: SHIMADZU MobileDaRt Evolution (MX8 Version) Recalled by Shimadzu Medical...

The Issue: In these units, the brake is usually released by gripping the drive handle...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 14, 2019· Becton Dickinson & Co.

Recalled Item: BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use Recalled by...

The Issue: False negative results with the BD MAX Extended Enteric Bacterial Panel when...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 14, 2019· Shimadzu Medical Systems Usa Com

Recalled Item: BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is...

The Issue: Normal operation of the device is to power up the device in the morning,...

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

Class II — Potential Health HazardOngoing