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. 2,637 recalls have been distributed to Tennessee in the last 12 months.

52,000 total recalls
2,637 in last 12 months

Showing 1500115020 of 29,188 recalls

Medical DeviceDecember 7, 2018· Siemens Healthcare Diagnostics, Inc

Recalled Item: Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462...

The Issue: Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 7, 2018· Siemens Healthcare Diagnostics, Inc

Recalled Item: Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number Recalled by...

The Issue: Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 7, 2018· Waldemar Link GmbH & Co. KG (Mfg Site)

Recalled Item: LINK STEM with Microporous Surface MP Reconstruction Prosthesis Recalled by...

The Issue: The reaming guide and the guide rod can't be screwed into the intended...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 7, 2018· Ethicon Endo-Surgery Inc

Recalled Item: PROXIMATE¿ PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: The...

The Issue: Hemorrhoidal Circular Stapler may have been assembled without a washer, this...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 7, 2018· Ethicon Endo-Surgery Inc

Recalled Item: PROXIMATE¿ HCS Hemorrhoidal Circular Stapler Product Code: PPH01 PPH01: The...

The Issue: Hemorrhoidal Circular Stapler may have been assembled without a washer, this...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 6, 2018· Carl Zeiss Meditec, Inc.

Recalled Item: VisuMax Software Version 2.10.13 with activated Software-Module ReLEx...

The Issue: VisuMax devices with software version 2.10.13 and activated SW-Module ReLEx...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 6, 2018· Medtronic Navigation, Inc.

Recalled Item: Medtronic Adapter Percutaneous Pin Recalled by Medtronic Navigation, Inc....

The Issue: Under certain circumstances, the percutaneous pin adapter used with the...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 6, 2018· Vygon U.S.A.

Recalled Item: Vygon DUALSTOP Red Cap used for intravascular lines Product Code: Recalled...

The Issue: DualStop Caps defect causing leaks in affected product

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 6, 2018· Vygon U.S.A.

Recalled Item: Vyon DUALSTOP White Cap used for intravascular lines Product Code: Recalled...

The Issue: DualStop Caps defect causing leaks in affected product

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 6, 2018· Bard Medical Division

Recalled Item: BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature...

The Issue: Some SureStep" Foley Tray Systems with product catalog number A319418AM and...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 6, 2018· Hologic, Inc.

Recalled Item: I-View¿ Contrast Enhanced Digital Mammography Recalled by Hologic, Inc. Due...

The Issue: Calibration issue not possible to visualize contrast uptake in the...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 5, 2018· Sage Products Inc

Recalled Item: Toothete Oral Care Sodium Bicarbonate Mouthpaste Recalled by Sage Products...

The Issue: A voluntary recall of a lot (67924) of Independent Care System due to the...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 5, 2018· Medela Inc

Recalled Item: Breast Milk Transfer Lid for use with Oral Syringe Connectors Model:...

The Issue: The sterility may be compromised due to a potential breach in the packaging,...

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

Class III — Low RiskOngoing
Medical DeviceDecember 5, 2018· Beckman Coulter Inc.

Recalled Item: UniCel DxC 660i Recalled by Beckman Coulter Inc. Due to When racks are...

The Issue: When racks are front-loaded onto the sample presentation unit while samples...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 5, 2018· Beckman Coulter Inc.

Recalled Item: The UniCel DxI 600 and 800 Access Immunoassay Systems Recalled by Beckman...

The Issue: When racks are front-loaded onto the sample presentation unit while samples...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 5, 2018· Exactech, Inc.

Recalled Item: Equinoxe Preserve Humeral Stem Recalled by Exactech, Inc. Due to Possibility...

The Issue: Possibility that the Equinoxe Preserve Humeral Stem, 8mm, was inadvertently...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 4, 2018· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Triton Sponge System (Software) Recalled by Stryker Instruments Div. of...

The Issue: Gauss Surgical is updating the Instructions for Use (IFU) for our Triton...

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

Class III — Low RiskOngoing
Medical DeviceDecember 4, 2018· Agfa-Gevaert, N.V.

Recalled Item: DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 Recalled by...

The Issue: After an upgrade of the software of the Overhead Tube Crane, there were...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 3, 2018· PENTAX of America Inc

Recalled Item: Pentax Medical C2 CryoBalloon Standard Focal Catheter Recalled by PENTAX of...

The Issue: Incorrect default dose and dose increments may be transmitted to the...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 3, 2018· PENTAX of America Inc

Recalled Item: Pentax Medical C2 CryoBalloon Pear Focal Catheter Recalled by PENTAX of...

The Issue: Incorrect default dose and dose increments may be transmitted to the...

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

Class II — Potential Health HazardOngoing