The Recall Desk

State

Tennessee product recalls

20,324 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.

13876–13900 of 20324

  • HighFDA (Devices)·Z-1232-2023·2023-03-15

    Cardiosave Rescue Pump Recall for Defective O-Rings Causing Helium Leaks

    Datascope is recalling 47 Cardiosave Rescue cardiac pump units due to damaged O-rings on the quick disconnect fitting causing helium leaks that interrupt therapy.

    Product
    Cardiosave Rescue. Model Number: 0998-00-0800-83.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1231-2023·2023-03-15

    Cardiosave intra-aortic balloon pump O-ring defects may interrupt therapy

    Damaged or worn O-rings on the Cardiosave pump console quick disconnect fitting can leak helium, potentially interrupting cardiac support therapy for affected patients.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D998-00-0800-32, D998-00-0800-33, D998-00-0800-35, D998-00-0800-36, D998-00-0800-45, D998-00-0800-52, D998-00-0800-53, D998-00-0800-55, D998-00-0800-65, D998-00-0800-83, D998-UC-0800-31, D998-UC-0800-33,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1228-2023·2023-03-15

    Tri-Staple 2.0 Surgical Stapler Reloads Recalled for Malfunction Risk

    Covidien is recalling certain Tri-Staple 2.0 surgical stapler reloads due to a mechanical defect that may cause the device to malfunction during surgery. Affected units may fail to form staples properly, potentially causing serious surgical complications.

    Product
    Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0419-2023·2023-03-15

    Daily Harvest French Lentil Crumbles Recalled for Gastrointestinal Illness

    Daily Harvest French Lentil + leek Crumbles (Item L02-VEGBN) are being recalled due to complaints of gastrointestinal illness. The recall affects 28,776 units distributed nationwide with lot codes from September through November 2022.

    Product
    Daily Harvest French Lentil + leek Crumbles, Item ID L02-VEGBN, Net Wt. 12 oz. (340g) Keep Frozen, Cook Thoroughly. Perishable. Store Frozen. Cook Thoroughly to internal temperature of 165F. Distr. by Daily Harvest Inc. New York, NY 10013.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1230-2023·2023-03-15

    Cardiosave Rescue IABP Helium Regulator Failures May Impair Function

    Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to helium regulator failures that may cause insufficient helium levels when the pump console is docked. The defect may affect device operation.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1223-2023·2023-03-15

    CardioMEMS PA Sensor Operates Outside Frequency Range at High Elevations

    Select CardioMEMS CM2000 PA sensors may operate outside their intended frequency range above 2,000 feet elevation, potentially causing inaccurate readings or signal acquisition problems in heart failure monitoring.

    Product
    CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1214-2023·2023-03-15

    Siemens epoc Host 2 blood gas analyzer recalled for pO2 measurement quality control issue

    Siemens is recalling 22,156 units of the epoc Host 2 blood gas analyzer due to pO2 measurement quality control issues related to barometric pressure. The devices are distributed worldwide.

    Product
    epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 epoc Host 2, Japan 10736390 epoc Host 2, Refurbished 10736393 epoc Host 2, Canada, Refurbished 10736394 epoc Host 2, Japanese, Refurbished
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1209-2023·2023-03-15

    COVID-19 Diagnostic Test Kits May Leak, Causing Invalid Results

    DiaSorin Molecular's Simplexa COVID-19 Direct test kits may leak, potentially causing contamination and invalid test results. The FDA has issued a Class II recall affecting approximately 90,142 units distributed nationwide.

    Product
    Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1216-2023·2023-03-15

    LATITUDE NXT Remote Patient Monitoring System Alerts Not Displaying

    Boston Scientific's LATITUDE NXT system failed to display cardiac alerts for 1,531 patient records during 2022. Contact Boston Scientific to determine if your patients were affected.

    Product
    LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0438-2023·2023-03-15

    NatraBio Cold and Sinus Nasal Spray Recalled for Manufacturing Deviation

    Nutraceutical Corporation is recalling NatraBio Cold & Sinus Nasal Spray (0.8 FL Oz) lot 222016 due to manufacturing deviations and product discoloration. The product was distributed nationwide.

    Product
    NatraBio, Cold& Sinus Nasal Spray, Homeopathic Medicine, 0.8 FL Oz. ( 24ml), Mfd. for Healthway Corp. Comments or Questions NatraBio Shelburne Falls, MA 01370 USA, UPC 3 71400 55711 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1212-2023·2023-03-15

    Blood Sample Collection Kits Shipped With Incorrect Identification Labels

    LetsGetChecked Blood Sample Collection kits were distributed with incorrect shipping labels that assigned samples to wrong users. This could result in incorrect Hepatitis C Virus test results or rejected samples due to demographic mismatches.

    Product
    LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1229-2023·2023-03-15

    Cardiosave Hybrid Intra-Aortic Balloon Pump recalled for helium regulator failure

    Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump models due to helium regulator failures that may prevent proper device operation and replenishment.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-33, 0998-UC-08
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1219-2023·2023-03-15

    CardioMEMS Heart Monitoring System Emissions May Interfere With Pacemakers

    FDA recalls CardioMEMS HF System patient monitor for radiofrequency signal emissions that can interfere with pacemakers, defibrillators, and other implanted medical devices. The emissions exceed radiofrequency limits.

    Product
    CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0416-2023·2023-03-15

    Shirakiku Shichimi Togarashi Spice Recalled for Undeclared Sesame

    Shirakiku Shichimi Togarashi spice (Lot 12262023) is recalled because it contains undeclared sesame due to potential product mix-up. The 2,617 packages were distributed nationwide and internationally.

    Product
    SPICE SHICHIMI TOGARASHI 300g UPC: 074410341213 Brand: Shirakiku Distributed by: Wismettac Asian Foods, Inc. Santa Fe Springs, CA 90670 Product of China
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1210-2023·2023-03-15

    Simplexa Flu A/B & RSV Diagnostic Kits Recalled for Leaking Components

    DiaSorin is recalling 4,142 Simplexa Flu A/B & RSV Direct Gen II diagnostic kits due to leaking Direct amplification Discs that may cause contamination, cross-contamination, invalid test results, and system error codes.

    Product
    Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1221-2023·2023-03-15

    CardioMEMS Hospital Electronics System RF Emissions May Interfere With Implanted Devices

    St. Jude Medical is recalling the CardioMEMS HF System (Model CM3000) due to excessive radiofrequency emissions that may interfere with pacemakers, defibrillators, and other implanted devices during use. The recall affects 1,905 units distributed worldwide.

    Product
    CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physician
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0415-2023·2023-03-15

    Chili Pepper Powder Recalled for Undeclared Sesame Allergen

    Shirakiku brand Chili Pepper Powder (ICHIMI TOGARASHI) is being recalled nationwide and internationally because it contains sesame that is not declared on the ingredient label. Consumers with sesame allergies should not consume this product.

    Product
    Chili Pepper Powder (ICHIMI TOGARASHI) 300g UPC: 074410341169 Brand: Shirakiku Distributed by: Wismettac Asian Foods, Inc. Santa Fe Springs, CA 90670 Product of China
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1236-2023·2023-03-15

    Genesis Sterilization Containers Recalled for Shelf-Life Testing Failure

    Carefusion's CD5 Series Genesis surgical sterilization containers are being recalled due to failure to meet shelf-life testing requirements, resulting in a potential breach of sterility. The recall affects 5,952 devices distributed worldwide.

    Product
    CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog number and product name: 1. CD5-3B, CONTAINER SHALLOW LG ENDO 3IN PERF; 2. CD5-3C, CONTAINER SHALLOW LG ENDO 3IN SOLID; 3. CD5-61B, GENESIS CONT LARGE ENDO PERF 28X11X6IN; 4. CD5-61C, GENESIS C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1233-2023·2023-03-15

    Monaco RTP System software may calculate radiation therapy doses inaccurately

    Elekta's Monaco RTP radiation therapy treatment planning software may display inaccurate radiation doses when re-optimizing plans after adding anatomical contours. The defect affects 2,020 units distributed nationwide and internationally.

    Product
    Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1224-2023·2023-03-15

    CardioMEMS PA Sensor models affected by radio-frequency range at high elevations

    St. Jude Medical recalls CardioMEMS PA Sensors that may operate outside intended frequency range above 2,000 feet elevation, risking inaccurate readings in heart failure monitoring. Approximately 1,905 units affected.

    Product
    CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0444-2023·2023-03-15

    FDA Drug Recall: Phenylephrine IV Bags Recalled for Manufacturing Deviations

    Denver Solutions recalls 1,212 units of Phenylephrine HCl IV bags nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The voluntary recall affects products distributed across the U.S. including government facilities.

    Product
    Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-150-82
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0436-2023·2023-03-15

    Verapamil Hydrochloride Tablets Recalled for Failed Dissolution Specification

    Amerisource Health Services LLC is recalling 422 cartons of Verapamil Hydrochloride Extended-Release Tablets, 120 mg due to failed dissolution testing. The tablets did not meet specifications for drug release.

    Product
    Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 Tablets per Carton (10 x 10), Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-493-01; NDC Unit Dose: 60687-493-11.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1227-2023·2023-03-15

    BIOPHEN Protein C 5 Kit Labeling Update for Reproductive Hazard

    The BIOPHEN Protein C 5 reagent kit from Aniara Diagnostica contains Cesium Chloride in Reagent 2, suspected of damaging fertility. The manufacturer is issuing updated product labeling with warnings about this regulatory classification change.

    Product
    BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated plasma. Protein C is a glycoprotein, vitamin K dependent, which inhibits coagulation. Protein C in plasma is measured following a specific activation with Protac (Agkistrodo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0449-2023·2023-03-15

    Drug manufacturer recalls Soltice Quick-RUB nationwide due to manufacturing deviations

    Ecometics, Inc. recalled Soltice Quick-RUB nationwide due to Current Good Manufacturing Practice (CGMP) deviations. This was a voluntary recall initiated by the manufacturer in February 2023.

    Product
    Soltice Quick-RUB (Menthol 5.1%, Camphor 5.1%) packaged in a) 1.33 oz (37g) plastic jars and b) 3 Oz (85g) plastic jars
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1215-2023·2023-03-15

    epoc Host 2 Diagnostic Analyzers Recalled for Oxygen Measurement Inaccuracy

    Siemens Healthcare Diagnostics is recalling 4,369 epoc Host 2 blood gas analyzers due to elevated oxygen measurements in quality control testing when adjusted for barometric pressure. No illnesses reported.

    Product
    epoc Host 2 as follows: Product SMN epoc NXS Host, US 11413475 epoc NXS Host, EU 11413497 epoc NXS Host, Japan 11413498 epoc NXS Host, Canada 11413506 epoc NXS Host, ROW 11413518 epoc NXS Host, China-Korea 11413583
    Category
    Medical Device
    Distribution
    Distributed nationwide