The Recall Desk

State

Tennessee product recalls

20,364 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.

15576–15600 of 20364

  • HighFDA (Devices)·Z-1706-2022·2022-09-21

    Roadrunner PC Hydrophilic Wire Guide Recalled Due to Sterility Compromise

    Cook Incorporated is recalling 496 units of the Roadrunner PC Hydrophilic Wire Guide due to packaging failure that may compromise sterility. No illnesses have been reported.

    Product
    Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-180 ORDER NUMBER (GPN) G07937. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1717-2022·2022-09-21

    Roadrunner UniGlide Vascular Wire Guide Recalled for Sterility Compromise

    Cook Incorporated is recalling 30 units of Roadrunner UniGlide Hydrophilic Wire Guides due to packaging failure that may compromise device sterility.

    Product
    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-150 ORDER NUMBER (GPN): G56152. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1727-2022·2022-09-21

    GXL Acetabular Liners Recalled Due to Non-Conforming Packaging

    Exactech recalled 132 GXL acetabular liners (hip implant components) due to non-conforming bags that may accelerate device wear. Units were distributed worldwide to the US and 13 countries.

    Product
    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH +5MM LAT LINER 15 DEG 36MM ID, SIZE H, REF 138-36-08 b. ACUMATCH +5MM LAT LINER 15 DEG 36MM ID, SIZE J, REF 138-36-09 c. ACUMATCH LINER 15 DEG 36MM ID, SIZE H, REF 132-36-08 d. ACUM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1515-2022·2022-09-21

    L-Carnitine Injectable Recalled Due to Sterility Assurance Failure

    Carolina Infusion is recalling L-Carnitine 500 mg/mL injectable vials nationwide due to lack of assurance of sterility. The affected lot 06132022@17 should not be administered.

    Product
    L-Carnitine 500 mg/mL Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1749-2022·2022-09-21

    FUJIFILM Surpria Imaging Software May Fail During Scanning

    Surpria software versions V3.11 and V3.22 may encounter processing errors that prevent image reconstruction, potentially requiring additional scans and exposing patients to unnecessary radiation.

    Product
    Surpria: Software Version V3.11, V3.22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1534-2022·2022-09-21

    FDA Recalls QUAD-MIX Injectable for Sterility Assurance Failure

    Carolina Infusion recalls QUAD-MIX injectable (Lot 08082022@3) nationwide due to lack of sterility assurance, a critical safety requirement for injectable medications.

    Product
    QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1731-2022·2022-09-21

    GXL Acetabular Liners Packaged Improperly May Experience Accelerated Wear

    Exactech is recalling certain GXL acetabular hip implant liners because non-conforming packaging may cause accelerated wear. No injuries have been reported.

    Product
    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1725-2022·2022-09-21

    GXL Acetabular Hip Implant Liners Recalled Due to Packaging Defect

    Exactech is recalling specific GXL acetabular hip implant liners due to non-conforming packaging that may cause accelerated device wear. The recall affects 1,017 devices distributed worldwide.

    Product
    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER SZ E 28MM ID, REF 144-28-05; b. 0 DEG ACUMATCH CONSTRAINED LINER SZ F 28MM ID, REF 144-28-06; c. 0 DEG ACUMATCH CONSTRAINED LINER SZ G 28MM ID, REF 144-28-07
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1715-2022·2022-09-21

    Vascular catheter wire guide recalled for sterility testing failure

    Cook Incorporated is recalling Roadrunner UniGlide Hydrophilic Wire Guides due to packaging testing failures that may compromise device sterility. The recall affects 865 units distributed nationwide and internationally.

    Product
    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150 ORDER NUMBER (GPN): G56176. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1707-2022·2022-09-21

    Roadrunner PC Hydrophilic Wire Guide Recalled Due to Packaging Integrity Failure

    Cook Incorporated is recalling 2,407 units of Roadrunner PC Hydrophilic Wire Guide due to failed packaging integrity testing that may compromise device sterility. No illnesses or injuries have been reported.

    Product
    Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RFSPC-35-180 ORDER NUMBER (GPN) G09608. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1529-2022·2022-09-21

    Injectable Medication TRI-MIX Recalled for Lack of Sterility Assurance

    Carolina Infusion is recalling TRI-MIX 30/1/60 Injectable (5 ML vials) nationwide due to lack of assured sterility. The affected lots have Beyond Use Dates in August and September 2022. Contact your healthcare provider if you received this product.

    Product
    TRI-MIX 30/1/60 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1522-2022·2022-09-21

    Injectable testosterone product recalled for sterility assurance defect

    Carolina Infusion is recalling TEST CYP 200 MG/ML Injectable due to the manufacturing process's inability to assure sterility. The affected lots were distributed nationwide; patients should not use the product.

    Product
    TEST CYP (Grapeseed) 200 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1536-2022·2022-09-21

    Lisinopril Tablets Recalled for Embedded Metal Contamination

    Lupin Pharmaceuticals is recalling Lisinopril 10 mg tablets due to discovery of a metal piece embedded in one tablet. Affected lot Q201182 was distributed nationwide to wholesalers.

    Product
    LISINOPRIL — LISINOPRIL (LISINOPRIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1524-2022·2022-09-21

    Injectable Steroid Product Recalled for Lack of Sterility Assurance

    Carolina Infusion is recalling its TEST CYP/DHEA injectable steroid vials nationwide because the manufacturer cannot assure they are sterile. The recall affects 348 vials with lot numbers from June-August 2022.

    Product
    TEST CYP/DHEA (Sesame) 200 MG/2.5 MG/ML Injectable, 10 ML vial, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1718-2022·2022-09-21

    Cook Roadrunner Hydrophilic Wire Guide Recalled for Potential Sterility Compromise

    Cook Incorporated is recalling the Roadrunner UniGlide Hydrophilic Wire Guide due to failed packaging sterility testing. The device's sterility may be compromised.

    Product
    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-80 ORDER NUMBER (GPN): G56151. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1710-2022·2022-09-21

    Vascular Catheter Wire Guide Recalled for Possible Sterility Compromise

    Cook Incorporated is recalling 585 Roadrunner UniGlide Hydrophilic Wire Guides because they failed packaging sterility tests, potentially compromising device sterility.

    Product
    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPW-35-150 ORDER NUMBER (GPN):G56149. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1730-2022·2022-09-21

    GXL Acetabular Liners Recalled Due to Non-Conforming Packaging and Accelerated Wear Risk

    Exactech's GXL acetabular hip implant liners are being recalled because they were packaged in non-conforming bags that may cause accelerated wear of the devices.

    Product
    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1516-2022·2022-09-21

    MIC/B12 Injectable Vials Recalled for Lack of Sterility Assurance

    Carolina Infusion is recalling MIC/B12 injectable vials due to lack of assurance of sterility. Affected lots were distributed nationwide.

    Product
    MIC/B12 25/50/50/1 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1732-2022·2022-09-21

    Exactech GXL Acetabular Hip Implant Liners Recalled for Accelerated Wear

    Exactech GXL acetabular hip implant liners may have been packaged in non-conforming bags, which could contribute to accelerated device wear. Approximately 17,929 units were distributed worldwide.

    Product
    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1742-2022·2022-09-21

    ZAP-X Radiosurgery System Software Issue May Cause Treatment Misalignment

    A software issue in the ZAP-X Radiosurgery System may cause incorrect treatment positioning in patients with large rotational deviations. The alignment algorithm could miscalculate treatment table offset values, potentially affecting treatment delivery.

    Product
    ZAP-X Radiosurgery System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1750-2022·2022-09-21

    Surpria 64 Software Error May Prevent Image Reconstruction During Scanning

    Surpria 64 CT scanner software versions V3.11 and V3.22 may encounter errors that prevent image reconstruction, requiring repeat scans that expose patients to additional radiation. 16 units nationwide are affected.

    Product
    Surpria 64: Software Version V3.11, V3.22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1527-2022·2022-09-21

    TRI-MIX 30/1/20 Injectable Recalled for Lack of Sterility Assurance

    Carolina Infusion is recalling TRI-MIX 30/1/20 Injectable vials due to lack of assurance of sterility. The recall affects multiple lots distributed nationwide.

    Product
    TRI-MIX 30/1/20 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1533-2022·2022-09-21

    FDA Recalls Injectable Medication Due to Sterility Assurance Failure

    Carolina Infusion's QUAD-MIX 30/2/60/0.15 injectable (Lot 08022022@12) is recalled nationwide because the manufacturer failed to assure sterility. Patients and healthcare providers should not use affected vials and should contact the manufacturer.

    Product
    QUAD-MIX 30/2/60/0.15 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1748-2022·2022-09-21

    SCENARIA View software error may require additional patient radiation exposure

    SCENARIA View imaging software errors prevent image reconstruction, which may require additional scans and expose patients to unnecessary radiation.

    Product
    SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1739-2022·2022-09-21

    Isopure ACDS Hemodialysis Equipment Recalled for Electrical Shock Risk

    Isopure Corp recalls its ACDS (Acidified Concentrate Distribution and Storage) system used in hemodialysis facilities due to a potential electrical safety hazard that may result in electric shock or arcing.

    Product
    Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis p
    Category
    Medical Device
    Distribution
    Distributed nationwide