The Recall Desk

State

Tennessee product recalls

20,304 recalls have nationwide distribution and so reach Tennessee. 0 additional recalls listed Tennessee specifically in their distribution scope.

About recalls in Tennessee

Most US product recalls have nationwide distribution — the manufacturer ships into every state and the recall sweeps the same way. We include those in this listing because they affect Tennessee consumers even though the source notice doesn’t name the state. State-specific recalls are usually for products with regional distribution (a regional dairy, a local store brand) or where the agency was able to narrow the affected shipments to specific destinations.

If you’re checking whether a recall affects your purchase, the recall detail page lists the exact production lot codes, UPCs, and best-by dates. Match those against your package — distribution scope is a starting filter, not the final answer.

11101–11125 of 20304

  • SevereFDA (Devices)·Z-0232-2024·2023-11-29

    VariSoft Infusion Set recalled for defective connector prone to unintended disconnection

    Unomedical is recalling 8,028 VariSoft infusion sets due to a manufacturing defect that makes the connector prone to unintended disconnection, potentially leading to missed insulin doses and serious blood glucose complications.

    Product
    VariSoft infusion set, Model Number 1002827
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0135-2024·2023-11-29

    Eye drops recalled for non-sterility due to bacterial contamination

    Cardinal Health's LEADER brand Dry Eye Relief eye drops are recalled nationwide due to non-sterility concerns. FDA found insanitary conditions and positive bacterial results from environmental sampling at the manufacturing facility.

    Product
    DRY EYE RELIEF — DRY EYE RELIEF (POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0116-2024·2023-11-29

    FDA Recalls Sodium Bicarbonate Injection for Silicone Particulate Contamination

    Exela Pharma Sciences recalls 8.4% sodium bicarbonate injection nationwide due to silicone particulate matter in vials. The FDA classified this Class I recall as affecting 355,220 vials.

    Product
    SODIUM BICARBONATE — SODIUM BICARBONATE (SODIUM BICARBONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0344-2024·2023-11-29

    Transnasal Esophagovideoscope Recalled Due to Unvalidated Drying Process

    Aizu Olympus is recalling the Transnasal Esophagovideoscope (Model PEF-V) because the channel air drying process was not validated, resulting in some units with wet channels that could cause infection.

    Product
    Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the esophagus and stomach. Model Number: PEF-V.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0337-2024·2023-11-29

    Hysterofiberscope Model HYF-XP Channel Drying Process Flaw Poses Infection Risk

    Aizu Olympus is recalling HYF-XP hysterofiberscopes because the channel air drying process was not validated. Some repaired units have wet channels that could harbor contamination and pose infection risk.

    Product
    Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0325-2024·2023-11-29

    IRON assay kits recalled for inaccurate diagnostic results

    Sentinel CH SpA is recalling IRON assay kits (Reference Numbers 6K95-41 and 6K95-30) that may produce falsely elevated results. Affected lots could cause inaccurate iron measurements and delays in patient test reporting.

    Product
    IRON assay, Reference Numbers 6K95-41 and 6K95-30
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0391-2024·2023-11-29

    Philips Achieva 1.5T MRI Systems Recalled for Gradient Coil Fire Risk

    Philips is recalling Achieva 1.5T MRI systems because the gradient coil component could fail and produce smoke or fire. The recall affects 2 units distributed worldwide.

    Product
    Achieva 1.5T Initial System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0398-2024·2023-11-29

    Robotic patient positioning system may move unexpectedly after interruption

    The ORION System robotic arm used in radiation therapy may suddenly accelerate or move unexpectedly when motion resumes after an interruption, creating a risk of collision with stationary equipment.

    Product
    ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00003
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0384-2024·2023-11-29

    Compress Device Short Anchor Plugs Recalled for Metal Burrs

    Biomet is recalling Compress Device Short Anchor Plugs (22 MM) used in orthopedic surgery because they may contain metal burrs in the transverse holes that could prevent drill or pin passage and extend surgical procedures.

    Product
    Compress Device Short Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178564
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0386-2024·2023-11-29

    Surgical implant anchor plugs may contain metal burrs affecting insertion

    Biomet's Compress Device Short Anchor Plugs may contain metal burrs in the transverse holes, which can prevent proper insertion of surgical tools and extend surgery time. The affected devices are distributed nationwide and internationally.

    Product
    Compress Device Short Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178566
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0322-2024·2023-11-29

    Medtronic Mo.Ma Ultra Cerebral Protection Device manifold stickers mislabeled

    Medtronic has recalled the Mo.Ma Ultra Proximal Cerebral Protection Device due to mislabeled manifold stickers. Both sides of affected units were labeled identically, potentially causing confusion about which ports control the proximal versus distal balloons.

    Product
    Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0326-2024·2023-11-29

    Alinity c Iron Reagent Recalled for Falsely Elevated Test Results

    The FDA is recalling Alinity c Iron Reagent lots due to inaccurate results. The reagent produces falsely elevated patient iron values and may prevent proper quality control verification.

    Product
    Alinity c Iron Reagent, Reference Number 08P3920
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0352-2024·2023-11-29

    Roche Tina-quant D-Dimer Test System Recalled for Inaccurate Results

    Roche is recalling Tina-quant D-Dimer Test System kits because they produce elevated results when used with lithium-heparin plasma samples, potentially affecting diagnostic accuracy.

    Product
    Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400 plus), 08105618190 - (cobas c 303 and 503)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0338-2024·2023-11-29

    Tracheal Fiberscope Airway Management Devices Recalled for Inadequate Channel Drying

    Aizu Olympus is recalling 65 tracheal fiberscope units worldwide due to an unvalidated air drying process. Moisture remaining in device channels after repair could allow contamination and pose an infection risk.

    Product
    Tracheal fiberscope-airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: LF-DP, LF-GP, LF-TP.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0381-2024·2023-11-29

    Biomet Compress Device Anchor Plugs Recalled for Metal Burrs

    Biomet is recalling Compress Device Short Anchor Plugs due to metal burrs that may prevent proper surgical installation and extend operation time. Distribution includes US nationwide and eight other countries.

    Product
    Compress Device Short Anchor Plug, 16 MM- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Item Number: 178558
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0392-2024·2023-11-29

    MRI Machine Gradient Coil Potential Failure Could Produce Smoke and Fire

    Philips Ingenia 1.5T CX MRI systems may experience gradient coil failure that could produce smoke and/or fire. The FDA has classified this as a Class II recall affecting 48 units distributed nationwide and internationally.

    Product
    Ingenia 1.5T CX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0329-2024·2023-11-29

    Colonoscopes Recalled for Unvalidated Channel Drying Process and Infection Risk

    Aizu Olympus is recalling certain colonoscope models because the channel air drying process was not validated. A small percentage of repaired units had water remaining in the channel, which could lead to infection risk.

    Product
    Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: CF-2T160I, CF-2T160L, CF-H170I, CF-H170L, CF-H180AI, CF-H180AL, CF-H180DI, CF-H180DL, CF-H190I, CF-H190L, CF-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0369-2024·2023-11-29

    Medline Manual Resuscitators Recalled for Backwards Manometer Leak

    Medline manual resuscitators are recalled due to a backwards leak in the integrated manometer that allows CO2 rebreathing. The defect affects multiple models used in respiratory care distributed nationwide.

    Product
    Medline manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Adult Resuscitator REF #s: CPRM1116FPM, CPRM1116FPM4, CPRM1116M, CPRM1116MC, CPRM1116PM, CPRM1116PMT, CPRM1126FM, CPRM1126FPM, CPRM1126FPWM, CPRM1126M; 2. Infant Resus
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0347-2024·2023-11-29

    Ureteralscopes recalled due to unvalidated drying process and contamination risk

    Aizu Olympus is recalling 1577 ureteralscope units due to an unvalidated channel air drying process that left some units with residual water after repair, creating a contamination and infection risk.

    Product
    Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct). Model Numbers: URF-P6, URF-P6R.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0378-2024·2023-11-29

    Biomet Compress Device Anchor Plugs recalled for metal burrs in transverse holes

    Biomet is recalling Compress Device Short Anchor Plugs due to potential metal burrs in the transverse holes that may prevent proper placement of drill pins during surgery, potentially extending surgical time.

    Product
    Compress Device Short Anchor Plug, 10 MM-Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Item Number: 178552
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0339-2024·2023-11-29

    Tracheal Videoscope Recall Due to Unvalidated Drying Process

    Aizu Olympus is recalling 61 tracheal videoscopes (Model LF-V) due to an unvalidated air drying process that left water in channels after repair. Water in the endoscope channels may become contaminated and pose an infection risk.

    Product
    Tracheal videoscope- For airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Number: LF-V.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0353-2024·2023-11-29

    BioFire FilmArray TORCH power switch may fail from electrical arcing

    BioFire FilmArray TORCH diagnostic devices have a power switch that may degrade from internal arcing and carbon buildup, potentially causing electrical short, device overheating, or failure to power on.

    Product
    FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen computer and USB ports. The BioFire FilmArray Torch (BioFire Torch) is an automated in vitro diagnostic (IVD) device intended for use with FDA-cleared or ap
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0367-2024·2023-11-29

    V-Care manual resuscitators recalled for CO2 rebreathing defect

    SunMed's Ventlab V-Care manual resuscitators are being recalled due to a backwards leak in the integrated manometer that allows CO2 rebreathing. Affected devices were distributed nationwide.

    Product
    Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. V-Care Child Resuscitator REF #s: VN4100MB, VN4100MCFB-3, VN4100MCP; 2. V-Care Infant Resuscitator REF #s: VN3100OB, VN3100MB-2, VN3100MB-M01, VNW3100MB-2, V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0382-2024·2023-11-29

    Biomet Compress Device Anchor Plug Recall - Metal Burrs May Extend Surgery

    Biomet is recalling Compress Device Short Anchor Plugs due to metal burrs that may prevent surgical instruments from passing through, potentially extending operative time.

    Product
    Compress Device Short Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178560
    Category
    Medical Device
    Distribution
    Distributed nationwide