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. 2,520 recalls have been distributed to Tennessee in the last 12 months.

52,000 total recalls
2,520 in last 12 months

Showing 2394123960 of 29,188 recalls

Medical DeviceNovember 6, 2014· Ortho-Clinical Diagnostics

Recalled Item: VITROS CHEMISTRY PRODUCTS TRIG Slides Recalled by Ortho-Clinical Diagnostics...

The Issue: Potential for biased results using the specific lot of VITROS CHEMISTRY...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 5, 2014· Philips Ultrasound, Inc.

Recalled Item: Additional devices identified in new FSN MA-FCO 83000190: QLAB versions...

The Issue: When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 5, 2014· Philips Ultrasound, Inc.

Recalled Item: Q-Station Quantification Software. Q-Station 3.0 with a2DQ and/or aCMQ...

The Issue: When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 5, 2014· Philips Ultrasound, Inc.

Recalled Item: EPIQ 5 Ultrasound System Recalled by Philips Ultrasound, Inc. Due to When...

The Issue: When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 5, 2014· Gambro Renal Products Inc

Recalled Item: Polyflux Revaclear Dialyzer Recalled by Gambro Renal Products Inc Due to...

The Issue: Gambro is initiating a field action for Polyflux Revaclear Dialyzer and...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 5, 2014· Toshiba American Medical Systems Inc

Recalled Item: Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A...

The Issue: Potential problem with the cardiac function analysis software (CFA)....

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 5, 2014· Toshiba American Medical Systems Inc

Recalled Item: Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A...

The Issue: Potential problem with the cardiac function analysis software (CFA)....

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 5, 2014· Philips Ultrasound, Inc.

Recalled Item: EPIQ 7 Ultrasound System Recalled by Philips Ultrasound, Inc. Due to When...

The Issue: When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 5, 2014· Gambro Renal Products Inc

Recalled Item: Polyflux Revaclear Max Dialyzer Recalled by Gambro Renal Products Inc Due to...

The Issue: Gambro is initiating a field action for Polyflux Revaclear Dialyzer and...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 4, 2014· Smith & Nephew, Inc.

Recalled Item: LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT Recalled by Smith & Nephew,...

The Issue: The stem taper on this device is undersized; the gauge point is not deep enough.

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 4, 2014· Aircraft Medical Limited

Recalled Item: McGrath MAC2 Video Laryngoscope Blades Product supplied in box of 50 items...

The Issue: The blade retaining clip may be difficult to engage and thereby increase the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 4, 2014· Novadaq Technologies, Inc.

Recalled Item: Non-sterile drape Recalled by Novadaq Technologies, Inc. Due to Mislabeling

The Issue: Non sterile-drape LUNA drape was inadvertently mislabeled with an additional...

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

Class III — Low RiskOngoing
Medical DeviceNovember 4, 2014· Medtronic MiniMed Inc.

Recalled Item: Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets Recalled by...

The Issue: Tubing may detach at the connect/disconnect location on the MiniMed...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 4, 2014· Novadaq Technologies, Inc.

Recalled Item: LUNA Chest Recalled by Novadaq Technologies, Inc. Due to Mislabeling

The Issue: Non sterile-drape LUNA drape was inadvertently mislabeled with an additional...

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

Class III — Low RiskOngoing
Medical DeviceNovember 4, 2014· Smith & Nephew, Inc.

Recalled Item: LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT Recalled by Smith & Nephew,...

The Issue: The stem taper on this device is undersized; the gauge point is not deep enough.

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 4, 2014· Smith & Nephew, Inc.

Recalled Item: LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT Recalled by Smith & Nephew,...

The Issue: The stem taper on this device is undersized; the gauge point is not deep enough.

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 4, 2014· Pulsion Medical Inc

Recalled Item: Pulsiocath PiCCO ProAQT Monitoring Kit Recalled by Pulsion Medical Inc Due...

The Issue: Internal testing and investigation of the packaging revealed cracks and...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 3, 2014· Elekta, Inc.

Recalled Item: MOSAIQ Product Usage: MOSAIQ is an oncology information system used Recalled...

The Issue: A problem can exist in MOSAIQ resulting in the display of incorrect numeric...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 31, 2014· Accuray Incorporated

Recalled Item: CyberKnife Robotic Radiosurgery System with the first generation IRIS...

The Issue: Software upgrade to correct potential safety issue related to CyberKnife...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 30, 2014· Alcon Research, Ltd.

Recalled Item: INFINITI VISION SYSTEM ULTRASOUND FMS. Single-use fluid management system....

The Issue: Alcon is conducting a medical device recall due to the possible presence of...

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

Class II — Potential Health HazardOngoing