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. 2,535 recalls have been distributed to Tennessee in the last 12 months.

52,000 total recalls
2,535 in last 12 months

Showing 2274122760 of 29,188 recalls

Medical DeviceMay 5, 2015· Siemens Medical Solutions USA, Inc

Recalled Item: Cios Alpha Recalled by Siemens Medical Solutions USA, Inc Due to under...

The Issue: under certain circumstances the Cios Alpha system may freeze during a procedure.

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 5, 2015· ResMed Ltd.

Recalled Item: Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator....

The Issue: The Astral device allows clinicians to disable all alarms including those...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 5, 2015· Siemens Medical Solutions USA, Inc

Recalled Item: ONCOR Avant Garde Recalled by Siemens Medical Solutions USA, Inc Due to...

The Issue: potential safety risk of collision of the LINAC gantry with the patient or...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 5, 2015· Edwards Lifesciences, LLC

Recalled Item: Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device Recalled by...

The Issue: Potential device damage on the strain relief near the hub area, which may...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 5, 2015· Edwards Lifesciences, LLC

Recalled Item: Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75....

The Issue: The product failed to meet the internal established statistical test...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 4, 2015· Remel Inc

Recalled Item: Remel Blood Agar (TSA w/sheep blood) plate packaged Recalled by Remel Inc...

The Issue: Product may be contaminated with Listeria monocytogenes.

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 4, 2015· Spine Wave, Inc.

Recalled Item: Spine Wave Access Kit Recalled by Spine Wave, Inc. Due to Mislabeling

The Issue: Mislabeled outer carton: Monopolar Probe is listed as 200 x 1.5mm when it...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 4, 2015· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Navigation System II-Cart Recalled by Stryker Instruments Div. of Stryker...

The Issue: Stryker initiated a device recall of the Navigation System II-Cart, Camera...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 2, 2015· Synovis Surgical Innovations, Inc.

Recalled Item: Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and...

The Issue: Baxter healthcare is recalling specific product codes of Vascu-Guard...

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

Class I — Serious Health HazardOngoing
Medical DeviceMay 1, 2015· Beaver-Visitec International Inc.

Recalled Item: BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon...

The Issue: Devon Light Glove in procedure kits may have holes/slits compromising...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 1, 2015· Beaver-Visitec International Inc.

Recalled Item: BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon...

The Issue: Devon Light Glove in procedure kits may have holes/slits compromising...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 1, 2015· Beaver-Visitec International Inc.

Recalled Item: BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon...

The Issue: Devon Light Glove in procedure kits may have holes/slits compromising...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 1, 2015· Beaver-Visitec International Inc.

Recalled Item: BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon...

The Issue: Devon Light Glove in procedure kits may have holes/slits compromising...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 1, 2015· Terumo Cardiovascular Systems Corporation

Recalled Item: Base for Terumo Advanced Perfusion System 1 Recalled by Terumo...

The Issue: Terumo CVS is implementing field correction activities to address the...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 1, 2015· Biomet, Inc.

Recalled Item: Unilateral external fixation ankle clamp Product Usage: Unilateral external...

The Issue: Ankle clamp was assembled incorrectly; the offset of the pin to the pivot...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 1, 2015· Beaver-Visitec International Inc.

Recalled Item: BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon...

The Issue: Devon Light Glove in procedure kits may have holes/slits compromising...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 1, 2015· Terumo Cardiovascular Systems Corporation

Recalled Item: 100/120V AC Recalled by Terumo Cardiovascular Systems Corporation Due to...

The Issue: Terumo CVS is implementing field correction activities to address the...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 1, 2015· Integra LifeSciences Corp. d.b.a. Integra Pain Management

Recalled Item: Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle) Recalled by...

The Issue: Integra LifeSciences Corp. d.b.a. Integra Pain Management Announces...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 30, 2015· Zimmer, Inc.

Recalled Item: PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual...

The Issue: Potential for uncured adhesive between the metal threaded insert and the...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 30, 2015· Neuro Kinetics, Inc.

Recalled Item: I-Portal¿ NOTC and VNG Recalled by Neuro Kinetics, Inc. Due to complaints of...

The Issue: complaints of system malfunction and unintended, sudden movement at start...

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

Class II — Potential Health HazardOngoing