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. 2,598 recalls have been distributed to Tennessee in the last 12 months.

52,000 total recalls
2,598 in last 12 months

Showing 1774117760 of 29,188 recalls

Medical DeviceJuly 31, 2017· ICU Medical, Inc.

Recalled Item: 120" (305 cm) 10 Drop Primary Set w/2 MicroClave¿ Recalled by ICU Medical,...

The Issue: Some devices were labeled as Does not contain DEHP even though the product...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 31, 2017· ICU Medical, Inc.

Recalled Item: 88" (224 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter Recalled by ICU...

The Issue: Some devices were labeled as Does not contain DEHP even though the product...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 31, 2017· ICU Medical, Inc.

Recalled Item: 140" (356 cm) Y-Type Blood Set w/170 Micron Filter Recalled by ICU Medical,...

The Issue: Some devices were labeled as Does not contain DEHP even though the product...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 31, 2017· Cook Inc.

Recalled Item: Central Venous Tray Triple Lumen Polyurethane Catheter Recalled by Cook Inc....

The Issue: Central venous catheters may not fit over guide wire potentially causing...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 31, 2017· Cook Inc.

Recalled Item: Central Venous Catheter Set Heparin Coated Triple Lumen Polyurethane...

The Issue: Central venous catheters may not fit over guide wire potentially causing...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 31, 2017· Cook Inc.

Recalled Item: Central Venous Catheter Set Triple Lumen Polyurethane Recalled by Cook Inc....

The Issue: Central venous catheters may not fit over guide wire potentially causing...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 31, 2017· Cook Inc.

Recalled Item: Central Venous Catheter Tray Triple Lumen Polyurethane Recalled by Cook Inc....

The Issue: Central venous catheters may not fit over guide wire potentially causing...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 31, 2017· Cook Inc.

Recalled Item: Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic...

The Issue: Central venous catheters may not fit over guide wire potentially causing...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 28, 2017· Roche Diagnostics Corporation

Recalled Item: Cobas 8000 Modular Series system Recalled by Roche Diagnostics Corporation...

The Issue: A software failure may incorrectly set the system settings to "default"...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 28, 2017· Brainlab AG

Recalled Item: AIRO Mobile CT System Recalled by Brainlab AG Due to Risk of unintended...

The Issue: Risk of unintended motion while the AIRO system is in transport mode.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 28, 2017· C.R. Bard, Inc.

Recalled Item: Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female Recalled...

The Issue: Specific lots labeled as an Antibacterial Hydrophilic Intermittent Catheter...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 28, 2017· NXTHERA

Recalled Item: Rezum System Recalled by NXTHERA Due to Needle Bond may not be able to...

The Issue: Needle Bond may not be able to withstand the tension force applied when the...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 27, 2017· Optovue, Inc.

Recalled Item: iFusion Recalled by Optovue, Inc. Due to FDA determined that a 510(k) is...

The Issue: FDA determined that a 510(k) is needed for the Vault Mapping software (also...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 27, 2017· Medtronic Navigation, Inc.

Recalled Item: VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559...

The Issue: The VCLAS 3mm, 10mm, and 15mm tip devices were not appropriately tested for...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 27, 2017· Optovue, Inc.

Recalled Item: iVue 500 with iScan Recalled by Optovue, Inc. Due to FDA determined that a...

The Issue: FDA determined that a 510(k) is needed for the Vault Mapping software (also...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 27, 2017· Optovue, Inc.

Recalled Item: iVue with Normative Database Recalled by Optovue, Inc. Due to FDA determined...

The Issue: FDA determined that a 510(k) is needed for the Vault Mapping software (also...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 27, 2017· Zimmer Surgical Inc

Recalled Item: A.T.S. 4000TS Tourniquet Systems Recalled by Zimmer Surgical Inc Due to...

The Issue: Updated on-device label and 3 pages of an updated Operator/Service Manual....

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 27, 2017· Zimmer Surgical Inc

Recalled Item: A.T.S. 2200TS Tourniquet Systems Recalled by Zimmer Surgical Inc Due to...

The Issue: Updated on-device label and 3 pages of an updated Operator/Service Manual....

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 26, 2017· Synthes (USA) Products LLC

Recalled Item: 2.5 mm Guide Rod Recalled by Synthes (USA) Products LLC Due to Possible lack...

The Issue: Possible lack of product sterility due to potential gaps/channeling in the...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 26, 2017· Synthes (USA) Products LLC

Recalled Item: 2.5 mm Reaming Rod Recalled by Synthes (USA) Products LLC Due to Possible...

The Issue: Possible lack of product sterility due to potential gaps/channeling in the...

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

Class II — Potential Health HazardOngoing