The Recall Desk

State

Tennessee product recalls

73,092 recalls have nationwide distribution and so reach Tennessee. 7,851 additional recalls listed Tennessee specifically in their distribution scope.

What the numbers show

Total
7,851
Critical
1,327
Severe
1,665
Most recent
2026-09-23

Of the 7,851 recalls naming Tennessee we have scored against our rubric, 1,327 (17%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,665 (21%) are Severe.

These figures cover only the 7,851 recalls whose distribution notice names Tennessee specifically. The 73,092 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

8376–8400 of 80943

  • HighFDA (Devices)·Z-1067-2025·2025-02-05

    Implantable VNS Therapy Generators May Stop Delivering Treatment

    LivaNova is recalling approximately 8,223 SenTiva VNS Therapy generators due to a potential internal component failure that may cause the implanted device to stop delivering seizure therapy. Affected patients should contact their physician.

    Product
    Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and exte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1069-2025·2025-02-05

    Bedside cardiac monitor system recalled for display distortion

    The muRata Vios Monitoring System Model 2050 bedside cardiac monitor has been recalled due to a software issue causing patient vital signs and ECG waveforms to flicker and become distorted on the Central Station Monitor. No injuries have been reported.

    Product
    muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1029-2025·2025-02-05

    AXIOS Stent Delivery System Outer Sheath Detachment Recall (47 Units)

    Boston Scientific's AXIOS Stent Delivery System (47 units affected) is recalled because the outer sheath can detach and prevent proper stent expansion, requiring device exchange.

    Product
    AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1040-2025·2025-02-05

    Medline Procedure Kits Recalled for Surgical Mask Bioburden Testing Failure

    Medline has recalled 749 procedure kits containing surgical masks that failed to meet bioburden testing standards under EN 14683. The affected kits were distributed nationwide.

    Product
    Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130; 2) VANTEX 7FR 3L 20CM CVC STOCK+ BUNDLE US. Reorder number STCVC01USGV; general surgical tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1055-2025·2025-02-05

    Karl Storz Uretero-Renoscope recalled for unapproved reprocessing instructions

    Karl Storz Endoscopy has recalled the KARL STORZ ENDOSKOPE Uretero-Renoscope nationwide because its instructions for use contain reprocessing procedures that lack FDA review and approval for safety and efficacy.

    Product
    KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1060-2025·2025-02-05

    Karl Storz Ureteroscope Recall Due to Unapproved Reprocessing Instructions

    Karl Storz ureteroscopes are being recalled because their instructions contain reprocessing procedures that have not been reviewed or approved by the FDA. The recall affects 3,069 units distributed nationwide.

    Product
    KARL STORZ - ENDOSKOPE, REF: 27010K, Ureteroscope, 7 Fr., 34 cm, NON STERILE, RxONLY, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1022-2025·2025-02-05

    Medtronic Percutaneous Reference Pins May Not Fit Properly

    Medtronic is recalling sterile percutaneous reference pins used in image-guided surgery because the pins may not fit into the patient reference frame or adapter, potentially affecting proper surgical tracking.

    Product
    Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous Reference Pin Set is intended to be used to place and remove a pin percutaneously into bony patient anatomy for rigid attachment of a pat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1039-2025·2025-02-05

    Knee Implant Component Recalled for Incorrect Metal Post Assembly

    Zimmer, Inc. is recalling 155 units of NexGen LCCK Legacy knee implant components because the metal support post was assembled incorrectly in some units. The defective assembly could compromise implant function.

    Product
    NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1061-2025·2025-02-05

    Karl Storz Ureteroscope recalled nationwide for unapproved reprocessing instructions

    Karl Storz Ureteroscope model 27000K is being recalled due to instructions for use containing reprocessing modalities not reviewed or approved by the FDA. The recall affects 82 units distributed nationwide.

    Product
    KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1020-2025·2025-02-05

    HemosIL Heparin Calibrators Recalled Over Quality Control Test Failures

    Instrumentation Laboratory recalls HemosIL Heparin Calibrators worldwide due to quality control failures. The diagnostic controls did not meet expected performance standards, potentially affecting accuracy of heparin testing in clinical laboratories.

    Product
    HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0212-2025·2025-02-05

    Duloxetine Delayed-Release Capsules recalled nationwide for nitrosamine impurity

    Duloxetine Delayed-Release Capsules USP 20 mg are being recalled nationwide due to presence of nitrosamine impurity above FDA acceptable limits. No adverse events have been reported.

    Product
    Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1025-2025·2025-02-05

    AXIOS Stent Delivery System: Detaching Outer Sheath May Prevent Stent Expansion

    Boston Scientific is recalling 1,144 AXIOS Stent Delivery System units because the outer sheath's distal black tip can detach. If this occurs, the tip may remain around the stent saddle and prevent proper stent expansion, requiring device exchange.

    Product
    AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1038-2025·2025-02-05

    Knee implant articular surface recalled for incorrect metal post assembly

    Zimmer, Inc. is recalling NexGen LCCK knee implant articular surface components due to incorrect assembly of the metal support post. The defect was identified internally in a small number of units.

    Product
    NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1068-2025·2025-02-05

    Implantable Vagus Nerve Stimulation Device May Stop Delivering Therapy

    LivaNova's SenTiva DUO vagus nerve stimulation device may stop delivering therapy due to an internal component issue. The recall affects 84 units distributed worldwide.

    Product
    Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, le
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1064-2025·2025-02-05

    Karl Storz Ureteroscope Recalled for Unapproved Reprocessing Instructions

    Karl Storz ureteroscopes contain reprocessing instructions that have not been reviewed and approved by the FDA. Affected devices should not be reprocessed using unapproved methods.

    Product
    KARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6¿, 34cm, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1031-2025·2025-02-05

    AXIOS Stent Delivery System recalled due to distal sheath detachment

    Boston Scientific is recalling 38 units of AXIOS Stent and Delivery System (15mmx10mm) because the outer sheath's distal tip may detach, preventing proper stent expansion and requiring device replacement.

    Product
    AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1052-2025·2025-02-05

    Karl Storz Cysto-Urethroscope Recalled for Unapproved Reprocessing Instructions

    Karl Storz is recalling 221 cysto-urethroscopes because their reprocessing instructions have not been FDA-approved. Medical facilities should stop using these devices until receiving updated instructions from the manufacturer.

    Product
    KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1028-2025·2025-02-05

    AXIOS Stent Distal Tip Detachment Prevents Proper Expansion

    Boston Scientific is recalling AXIOS Stent devices due to outer sheath distal tip detachment that can prevent proper stent expansion and require device replacement during the procedure.

    Product
    AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1042-2025·2025-02-05

    Medline procedure kits recalled for surgical mask bioburden contamination risk

    Medline procedure kits containing surgical masks are recalled nationwide because included masks failed to meet bioburden testing standards, creating potential infection risk during medical procedures.

    Product
    Medline procedure kits labeled as: 1) CENTRAL LINE DRESSING KIT, Reorder number DYNDC3189; dressing change tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1063-2025·2025-02-05

    Karl Storz Ureteroscope Recalled for Unapproved Reprocessing Instructions

    Karl Storz is recalling 180 ureteroscopes due to instructions for use containing reprocessing procedures that have not been reviewed or approved by the FDA.

    Product
    KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1024-2025·2025-02-05

    AXIOS Stent Delivery System Outer Sheath May Detach During Deployment

    Boston Scientific's AXIOS Stent Delivery System is being recalled because the outer sheath can detach during use, preventing proper stent expansion and requiring device exchange.

    Product
    AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0209-2025·2025-02-05

    Badger 50 Mineral Sunscreen Recalled for Missing Drug Facts Labeling

    The W.S. Badger Company is recalling Badger 50 mineral sunscreen tins lacking the complete drug facts label, barcode, and directions for use. The recall affects 4,834 tins distributed nationwide.

    Product
    BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoated 25% zinc oxide), 2.4 oz., Tin, W.S. Badger Company, Inc, 768 Route 10, Gilsum NH, 03448 UPC 6 34084 47150 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·25V054000·2025-02-04

    Highland Ridge Recalls 2025 Open Range 3X Trailers for Incorrect Tire Labeling

    Highland Ridge RV is recalling 2025 Open Range 3X fifth-wheel travel trailers because the vehicle certification label lists the wrong tire size, which could lead to incorrect tire installation.

    Product
    HIGHLAND RIDGE FW — HIGHLAND RIDGE FW OPEN RANGE 3X
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V052000·2025-02-03

    Temsa Recalls 2024 TS35 Vehicles Due to Fuel Hose Separation Risk

    Temsa is recalling 2024 TS35 vehicles with Cummins L9 engines because fuel filter hoses may separate, causing leaks, engine stalls, and fire or crash risks.

    Product
    TEMSA — TEMSA TS35
    Category
    Vehicle
    Distribution
    Distributed nationwide