Product Recalls in Tennessee

Product recalls affecting Tennessee — including food, drugs, consumer products, medical devices, and vehicles distributed to Tennessee. RecallDetector monitors distribution data from the FDA, USDA, CPSC, and NHTSA to show you which recalls are relevant to your area. 2,536 recalls have been distributed to Tennessee in the last 12 months.

52,000 total recalls
2,536 in last 12 months

Showing 1974119760 of 52,000 recalls

Medical DeviceFebruary 24, 2020· Butterfly Network, Inc.

Recalled Item: Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder...

The Issue: Distributed without an approved 510(k)

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 24, 2020· Butterfly Network, Inc.

Recalled Item: Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction)...

The Issue: Distributed without an approved 510(k)

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 24, 2020· LivaNova USA Inc.

Recalled Item: LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T...

The Issue: The firm is providing validated cleaning and disinfection instructions in...

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

Class II — Potential Health HazardOngoing
DrugFebruary 21, 2020· Akorn, Inc.

Recalled Item: Well at Walgreens Sodium Chloride Ophthalmic Ointment USP Recalled by Akorn,...

The Issue: Presence of Particulate Matter: Brown spots observed on the inside of the...

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

Class III — Low RiskOngoing
Refund
DrugFebruary 21, 2020· Akorn, Inc.

Recalled Item: CVS Health Sodium Chloride Ophthalmic Ointment USP Recalled by Akorn, Inc....

The Issue: Presence of Particulate Matter: Brown spots observed on the inside of the...

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

Class III — Low RiskOngoing
Refund
DrugFebruary 21, 2020· Akorn, Inc.

Recalled Item: Sodium Chloride Ophthalmic Ointment USP Recalled by Akorn, Inc. Due to...

The Issue: Presence of Particulate Matter: Brown spots observed on the inside of the...

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

Class III — Low RiskOngoing
Refund
FoodFebruary 21, 2020· Moonstruck Chocolate Company

Recalled Item: Moonstruck Praline Pecan & Ginger Element Bar in Dark Chocolate Recalled by...

The Issue: Undeclared milk.

Recommended Action: Do not consume. Return to store for a refund or discard.

Class I — Serious Health HazardOngoing
Refund
FoodFebruary 21, 2020· Kaiser Pickles LLC

Recalled Item: Kaiser Mild Banana Pepper Rings 1/4 KK in 1 gallon Recalled by Kaiser...

The Issue: Possible foreign material.

Recommended Action: Do not consume. Return to store for a refund or discard.

Class II — Potential Health HazardOngoing
Refund
Medical DeviceFebruary 21, 2020· Epimed International

Recalled Item: R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496...

The Issue: Incorrect expiration date on introduction cannula packaging.

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 21, 2020· Epimed International

Recalled Item: R-F Injector Cannula. 20gx10cm-STERILE. REF/UDI: 257-2010/(01)10818788022124...

The Issue: Incorrect expiration date on introduction cannula packaging.

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 21, 2020· Qiagen Sciences LLC

Recalled Item: AmniSure ROM Test Recalled by Qiagen Sciences LLC Due to An image on the...

The Issue: An image on the associated polybag contains an incorrect rinse time of 30...

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

Class II — Potential Health HazardOngoing
DrugFebruary 20, 2020· Teva Pharmaceuticals USA

Recalled Item: Mesalamine Delayed-Release Tablets Recalled by Teva Pharmaceuticals USA Due...

The Issue: Failed Dissolution Specifications: Low out of specification dissolution...

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

Class II — Potential Health HazardOngoing
Refund
Medical DeviceFebruary 20, 2020· Radiometer Medical ApS

Recalled Item: TCM4 Base unit Recalled by Radiometer Medical ApS Due to Reports have been...

The Issue: Reports have been received about the transcutaneous monitoring system...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 20, 2020· Maquet Cardiovascular Us Sales, Llc

Recalled Item: Avalon Elite Vascular Access Kit Recalled by Maquet Cardiovascular Us Sales,...

The Issue: A lot of Avalon Elite Vascular Access Kits (VAK) are being recalled due to a...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 20, 2020· Philips North America, LLC

Recalled Item: Expression MR400 MRI Patient Monitoring System Model Number: 866185 Software...

The Issue: Menu selections for users to access the oxygen (O2) sensor calibration were...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 20, 2020· RAYSEARCH LABORATORIES AB

Recalled Item: RayStation/RayPlan 8B Service Pack 2 Recalled by RAYSEARCH LABORATORIES AB...

The Issue: There is a potential for erroneous propagation of the current tabletop...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 20, 2020· RAYSEARCH LABORATORIES AB

Recalled Item: RayStation/RayPlan 8A Service Pack 1 Recalled by RAYSEARCH LABORATORIES AB...

The Issue: There is a potential for erroneous propagation of the current tabletop...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 20, 2020· RAYSEARCH LABORATORIES AB

Recalled Item: RayStation/RayPlan 8B Service Pack 1 Recalled by RAYSEARCH LABORATORIES AB...

The Issue: There is a potential for erroneous propagation of the current tabletop...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 20, 2020· RAYSEARCH LABORATORIES AB

Recalled Item: RayStation/RayPlan 9B Recalled by RAYSEARCH LABORATORIES AB Due to There is...

The Issue: There is a potential for erroneous propagation of the current tabletop...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 20, 2020· RAYSEARCH LABORATORIES AB

Recalled Item: RayStation/RayPlan 8B Recalled by RAYSEARCH LABORATORIES AB Due to There is...

The Issue: There is a potential for erroneous propagation of the current tabletop...

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

Class II — Potential Health HazardOngoing