The Recall Desk

State

Tennessee product recalls

19,789 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.

5301–5325 of 19789

  • HighFDA (Devices)·Z-1368-2025·2025-03-26

    Proxima Drape sterile drapes recalled for potential packaging breach risk

    Medline Industries is recalling Proxima Drape sterile surgical drapes due to potential breaches in pouch packaging that could compromise sterility. The recall affects 2,422 units distributed nationwide.

    Product
    Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUCH-LF, VEIN PACK. Sterile surgical drape.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1353-2025·2025-03-26

    Medical Pump Kits Recalled for Unconfirmed Sterilization and Functionality Loss

    American Contract Systems Inc is recalling 134 CV Basic Pump Pack kits because the manufacturer cannot confirm sterilization requirements were met. Possible loss of functionality could delay or prolong patient treatment.

    Product
    CV BASIC PUMP PACK , Model No WECV23D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1389-2025·2025-03-26

    Candida ID Antigen recalled for reduced sensitivity, potential false negatives

    Immuno-Mycologics' Candida ID Antigen may have reduced sensitivity, causing false negative diagnostic results. Lot F4171005 has been distributed worldwide including CA and OK.

    Product
    Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for use in the ID test, RX only, IVD, CE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0286-2025·2025-03-26

    Injectable Drug Recalled for Stability Issues at Expiration

    Amgen recalls 258,750 vials of Neupogen (filgrastim) injection due to stability concerns. Stability data shows products may be out of specification at expiration; patients should consult healthcare providers about affected lots.

    Product
    NEUPOGEN — NEUPOGEN (FILGRASTIM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1347-2025·2025-03-26

    Hip Prosthesis Pack Recalled Due to Sterilization Assurance Concerns

    American Contract Systems Inc is recalling TOTAL HIP PACK models SMTH06O and SMTH06P due to inability to confirm sterilization requirements were met. Unsterilized devices could malfunction and delay patient treatment.

    Product
    TOTAL HIP PACK , Model No SMTH06O SMTH06P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1365-2025·2025-03-26

    Sterile Surgical Drape Recalled Due to Potential Packaging Breach

    Medline Industries is recalling 114 units of Proxima Drape surgical drapes due to a potential breach in pouch packaging that could compromise sterility. Affected units were distributed nationwide.

    Product
    Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1388-2025·2025-03-26

    DxI 9000 Access Immunoassay Analyzer Encoder Wheel Misalignment

    Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer (206 units) because an encoder wheel misalignment on the motor shaft can cause the instrument to stop and delay patient test results.

    Product
    DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0280-2025·2025-03-26

    Prasugrel 5 mg Tablets Recalled Due to Failed Dissolution Specifications

    Mylan Pharmaceuticals is recalling specific lots of Prasugrel 5 mg tablets due to failed dissolution specifications. The affected tablets may not dissolve properly in the body.

    Product
    PRASUGREL — PRASUGREL (PRASUGREL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1378-2025·2025-03-26

    Microstream CO2 sampling lines recalled for difficult adapter disconnection

    Microstream CO2 sampling lines may be difficult to disconnect from endotracheal tubes, potentially delaying treatment or causing unintended tube removal.

    Product
    Microstream Instructions for Use and Part Number used with - Product Description, REF: Filter Line Sets Adult/Pediatric & Infant/Neonatal, 10129497 - CapnoLine Neonatal-Infant Intubated Filter Line with Microstream Technology H, Length 7 (2.0 m), 006324COV; CapnoLine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1354-2025·2025-03-26

    Diagnostic Neuro IR Tray recalled for unconfirmed sterilization

    American Contract Systems Inc is recalling 170 Diagnostic Neuro IR Tray kits due to inability to confirm sterilization assurance requirements were met. The units may lose functionality and cause treatment delays.

    Product
    DIAGNOSTIC NEURO IR TRAY , Model No WENE21
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1358-2025·2025-03-26

    Vascular Pack Sterilization Assurance Requirements Cannot Be Confirmed

    American Contract Systems cannot confirm Major Vascular Pack surgical kits were properly sterilized. Sterilization assurance failure could result in loss of functionality and delayed patient treatment.

    Product
    MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1405-2025·2025-03-26

    CAPNOCHECK Airway Adapter May Break Off, Risking Ventilation Loss

    CAPNOCHECK BCI Airway Adapters may break off when a valve or tube is attached, causing airway circuit disconnection and loss of ventilation. This could result in inability to ventilate, hypoxia, cardiopulmonary collapse, or death.

    Product
    CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1363-2025·2025-03-26

    Medline Proxima sterile surgical drapes recalled due to potential packaging breach

    Medline is recalling 1,482 units of Proxima sterile surgical drapes due to potential breaches in pouch packaging that could compromise sterility. No illnesses have been reported.

    Product
    Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAPE,SPLIT,CVMAX,6/CS; DRAPE,ORTHOMAX ,BAR,6/CS; DRA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1392-2025·2025-03-26

    Medical Device Software May Merge Patient Records Without Notification

    Brainlab's Origin Data Management software versions 3.1.0 through 3.2.1 may automatically merge patient records from unrelated individuals without user notification, creating a risk of incorrect patient data being used in clinical care.

    Product
    Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1403-2025·2025-03-26

    Shoulder Prosthesis Stem Excess Material Prevents Proper Surgical Assembly

    Zimmer Orthopedics recalls shoulder prosthesis models due to excess material in the taper that prevents proper surgical assembly. Five complaints reported.

    Product
    Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1356-2025·2025-03-26

    AV Fistula Kit Recall Due to Unconfirmed Sterilization Assurance

    American Contract Systems Inc is recalling 90 AV Fistula kits because sterilization assurance requirements cannot be confirmed. Possible loss of functionality could delay or prolong patient treatment.

    Product
    AV FISTULA , Model No UTAV77T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1351-2025·2025-03-26

    EAR PACK Medical Device Recalled Over Unconfirmed Sterilization

    American Contract Systems Inc is recalling 51 kits of the EAR PACK Model SFEA12A because the manufacturer could not confirm sterilization requirements were met, which could cause device malfunction and delayed treatment.

    Product
    EAR PACK , Model No SFEA12A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1336-2025·2025-03-26

    C-Section Surgical Packs Recalled Over Sterilization Assurance Failure

    American Contract Systems is recalling C-Section surgical packs (252 kits) after being unable to confirm sterilization assurance. Lack of verified sterilization could delay or prolong surgical treatment.

    Product
    C-SECTION PACK, Model Nos LLCS44F LLCS44F-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1376-2025·2025-03-26

    CO2 Sampling Lines May Fail to Disconnect During Neonatal Care

    Microstream CO2 sampling lines and airway adapters may be difficult or impossible to disconnect from endotracheal tubes, potentially delaying treatment or causing unintended extubation. The defect affects neonatal and pediatric patients worldwide.

    Product
    Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine H Set & VitaLine H Set Infant/Neonatal, 006147 - MICROSTREAM FilterLine H Set Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 006324; MICROSTREAM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1342-2025·2025-03-26

    Surgical Positioning Device Recalled for Unconfirmed Sterilization Assurance

    American Contract Systems Inc is recalling C-Section PPS positioning systems due to inability to confirm sterilization assurance requirements were met. The failure could lead to loss of functionality and delayed treatment.

    Product
    C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1348-2025·2025-03-26

    Delivery Pack Medical Device Sterilization Assurance Not Confirmed

    American Contract Systems Inc is recalling Delivery Pack medical devices (Models SGDV22D-01 and SGDV22E) because sterilization assurance requirements were not confirmed. Unsterilized devices may not function properly and could delay treatment.

    Product
    DELIVERY PACK , Model No SGDV22D-01 SGDV22E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1352-2025·2025-03-26

    Laparoscopy Surgical Packs Recalled Due to Unconfirmed Sterilization

    American Contract Systems Inc is recalling 237 laparoscopy surgical packs because sterilization assurance could not be confirmed. The packs may experience loss of functionality and require treatment delays.

    Product
    LAPAROSCOPY PACK , Model No SFLA02A SFLA02B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1367-2025·2025-03-26

    Medline Proxima Sterile Surgical Drapes Recalled for Packaging Breach Risk

    Medline Industries is recalling Proxima Drape sterile surgical drapes due to potential packaging breach that could compromise sterility. The recall affects 16 units distributed nationwide.

    Product
    Proxima Drape labeled as FACE LIFT. Sterile surgical drape.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1345-2025·2025-03-26

    FDA Recalls URO Robotic Pack Surgical Kit Due to Sterilization Concerns

    American Contract Systems Inc recalls 41 URO Robotic Pack surgical kits distributed in Ohio because sterilization assurance requirements could not be confirmed. Non-sterile equipment may lead to delayed treatment.

    Product
    URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03
    Category
    Medical Device
    Distribution
    Distributed nationwide