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. 2,661 recalls have been distributed to Tennessee in the last 12 months.

52,000 total recalls
2,661 in last 12 months

Showing 1220112220 of 29,188 recalls

Medical DeviceMarch 30, 2020· Boston Scientific Corporation

Recalled Item: MoXy Laser Fiber Recalled by Boston Scientific Corporation Due to To...

The Issue: To reinforce existing instructions within the Directions for Use (DFU) and...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 30, 2020· Elekta Inc

Recalled Item: Leksell Vantage Stereotactic System. Instrument Carrier Recalled by Elekta...

The Issue: A faulty locking piece of the Instrument Carrier that does not fulfil the...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 27, 2020· Stryker Sustainability Solutions

Recalled Item: Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter Recalled by Stryker...

The Issue: A subset of temporary intracardiac ultrasound catheters are labeled with the...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 27, 2020· Edwards Lifesciences, LLC

Recalled Item: Sterile Oxymetry Oligon Catheter Kit. Pressure injectable....

The Issue: Sterile catheter kit packaging compromised.

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 26, 2020· Shanghai United Imaging Healthcare Co., Ltd.

Recalled Item: Positron Emission Tomography and Computed Tomography System Recalled by...

The Issue: In affected software version, of Positron emission tomography and computed...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 26, 2020· Medtronic Sofamor Danek USA Inc

Recalled Item: VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628...

The Issue: Nonconforming product; length of the product measured shorter than the...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 26, 2020· Gentell, Inc

Recalled Item: Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing...

The Issue: During an FDA audit, it was discovered that the product was not properly...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 26, 2020· Gentell, Inc

Recalled Item: Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing...

The Issue: During an FDA audit, it was discovered that the product was not properly...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 26, 2020· Gentell, Inc

Recalled Item: Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing...

The Issue: During an FDA audit, it was discovered that the product was not properly...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 26, 2020· Gentell, Inc

Recalled Item: Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing...

The Issue: During an FDA audit, it was discovered that the product was not properly...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 25, 2020· Abbott Vascular

Recalled Item: Xience Sierra TM Everolimus Eluting Coronary Stent System Recalled by Abbott...

The Issue: Incorrect expiration date

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 23, 2020· Janus Trade Group

Recalled Item: B. Braun Introcan Safety IV Catheters Recalled by Janus Trade Group Due to...

The Issue: Distribution of B.Braun Introcan Safety IV catheters without a 510(k) within...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 23, 2020· INARI MEDICAL

Recalled Item: Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/...

The Issue: The hemostasis valve of aspiration guide catheter devices may fail to seal...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 23, 2020· The Magstim Company Limited

Recalled Item: Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is Recalled...

The Issue: It was identified that there is a potential for the Stim Interconnecting...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 23, 2020· The Magstim Company Limited

Recalled Item: Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for...

The Issue: It was identified that there is a potential for the Stim Interconnecting...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 23, 2020· Olympus Corporation of the Americas

Recalled Item: Olympus Pleuravideoscope Recalled by Olympus Corporation of the Americas Due...

The Issue: There was no data to validate that the identified endo-therapy devices were...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 23, 2020· Olympus Corporation of the Americas

Recalled Item: Olympus Pleuravideoscope Recalled by Olympus Corporation of the Americas Due...

The Issue: There was no data to validate that the identified endo-therapy devices were...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 23, 2020· LeMaitre Vascular, Inc.

Recalled Item: LeMaitre 5F Plus Over the Wire Embolectomy Catheter Recalled by LeMaitre...

The Issue: There has been an increased trend in reports of catheters failing to deflate...

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

Class I — Serious Health HazardOngoing
Medical DeviceMarch 20, 2020· Utak Laboratories Inc

Recalled Item: Utak NR Trace Elements Serum Control Recalled by Utak Laboratories Inc Due...

The Issue: The product has an incorrect value for cadmium and an incorrect expected range.

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

Class III — Low RiskOngoing
Medical DeviceMarch 20, 2020· Physio-Control, Inc.

Recalled Item: LifePAK 500 Automated External Defibrillator Recalled by Physio-Control,...

The Issue: Automated External Defibrillators may not detect a patient connection due to...

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

Class II — Potential Health HazardOngoing