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. 2,645 recalls have been distributed to Tennessee in the last 12 months.

52,000 total recalls
2,645 in last 12 months

Showing 1232112340 of 29,188 recalls

Medical DeviceFebruary 26, 2020· Capso Vision, Inc.

Recalled Item: The CapsoCam Plus (SV-3) Recalled by Capso Vision, Inc. Due to Ingestible...

The Issue: Ingestible video capsule system has capsule with incorrect capture mode...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 26, 2020· Philips North America, LLC

Recalled Item: HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A...

The Issue: Philips has received a number of reports of HeartStart MRx...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 25, 2020· Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical

Recalled Item: Nexus Universal with OptiBond Universal Recalled by Kerr/Pentron, DBA Kerr...

The Issue: An issue within production process used to package trial kits let to the...

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 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
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
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
Medical DeviceFebruary 20, 2020· RAYSEARCH LABORATORIES AB

Recalled Item: RayStation/RayPlan 8A 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 9A 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 19, 2020· Haemonetics Corporation

Recalled Item: TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0...

The Issue: Software defect in TEG Manager impacts the displayed alert for out of range...

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

Class II — Potential Health HazardOngoing