The Recall Desk

State

Tennessee product recalls

73,100 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 73,100 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

8776–8800 of 80951

  • HighFDA (Devices)·Z-0737-2025·2025-01-01

    Blood Analysis System Software Malfunction May Assign Incorrect Patient Names

    Siemens epoc NXS Host blood analysis systems contain a software malfunction that may assign incorrect patient names to blood measurements. This could result in clinicians making treatment decisions based on the wrong patient's test results.

    Product
    epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0738-2025·2025-01-01

    Siemens Blood Analysis System Software Malfunction May Cause Patient Identification Error

    Siemens epoc NXS Host blood analysis systems are recalled due to a software malfunction that can assign incorrect patient names to blood tests, potentially leading to misdiagnosis or mistreatment.

    Product
    epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0742-2025·2025-01-01

    Galaxy System bronchoscope power supply defect may injure lung tissue

    Noah Medical's Galaxy System bronchoscope has defective power supply semiconductors that may fail during procedures, potentially causing pneumothorax or lung tissue injury when the scope is manually removed.

    Product
    Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0767-2025·2025-01-01

    Siemens magnesium reagent cartridges recalled for false measurement results

    Siemens is recalling two lots of Magnesium Flex reagent cartridges due to potential falsely low magnesium measurements. The intermittent error may not be detected by standard quality control procedures.

    Product
    Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0162-2025·2025-01-01

    Duloxetine antidepressant recall for chemical impurity above FDA limit

    Breckenridge Pharmaceutical is recalling Duloxetine 60 mg delayed-release capsules due to N-nitroso-duloxetine impurity above FDA's interim limit. The recall affects 76,968 bottles distributed nationwide.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0734-2025·2025-01-01

    Blood Analysis System Recalled Due to Patient Name Assignment Software Error

    Siemens is recalling the epoc NXS Host blood analysis system due to a software defect that can incorrectly assign patient names to test results, potentially causing misdiagnosis and mistreatment.

    Product
    epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capill
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0739-2025·2025-01-01

    Blood Analysis System Software Error Can Assign Wrong Patient Name

    Siemens epoc NXS Host blood analysis devices have a software malfunction that may assign the wrong patient name to blood test results, potentially leading to misdiagnosis or mistreatment.

    Product
    epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or ca
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0165-2025·2025-01-01

    Duloxetine delayed-release capsules recalled due to manufacturing impurity

    Duloxetine delayed-release 60mg capsules are being recalled nationwide due to N-nitroso-duloxetine impurity above recommended interim limits. Two lot numbers are affected: J0786744-061724 (blister cards) and B3002625-060524 (bottles).

    Product
    Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0760-2025·2025-01-01

    RUMMELL Medline Medical Device Weak Seals Sterility Risk Recall

    Medline RUMMELL units may have weak seals that could compromise sterility and increase infection risk. Approximately 21,440 units distributed nationwide are affected.

    Product
    RUMMELL, Medline Item No. ST006ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0752-2025·2025-01-01

    FDA Recalls Medical Spine Component Due to Manufacturing Defects

    SEASPINE Orthopedics is recalling 191 Daytona Small Stature Ti Locking Caps due to manufacturing defects that prevent proper component mating.

    Product
    Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25 Model/Catalog Number: 79-0001 Software Version: N/A Product Description: Locking Cap Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0719-2025·2025-01-01

    Surgical Patties and Strips Recalled for Endotoxin Contamination

    Medline Industries recalls DIEP FLAP Convenience kits containing surgical patties and strips due to higher-than-expected endotoxin contamination that may not meet sterile product specifications.

    Product
    DIEP FLAP Convenience kit, SKU DYNJ910120. Convenience kits used for various procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0762-2025·2025-01-01

    MISHA Knee System Implants recalled due to fracture risk

    Moximed is recalling 115 MISHA Knee System Implants in multiple US states due to a supplier component defect that may cause the implant to fracture, potentially leading to pain, swelling, and stiffness.

    Product
    MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0756-2025·2025-01-01

    Medline Surgical Needle Holders Recalled for Sterility Compromise

    Medline is recalling 21,440 surgical needleholders due to weak seals that may compromise sterility and increase risk of contamination and infection during surgical use.

    Product
    ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Medline Item No. 67870
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0728-2025·2025-01-01

    O&M Halyard Procedure Masks Recalled for Unmet Bioburden Testing Requirements

    O&M HALYARD is recalling O&M Halyard Procedure Masks (Product Code 47117) nationwide because they do not meet bioburden testing requirements printed on the packaging.

    Product
    O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0722-2025·2025-01-01

    Surgical Patties and Strips Recalled for Elevated Endotoxin Levels in Kits

    Medline Industries is recalling SEPTOPLASTY PACK convenience kits nationwide due to higher-than-expected endotoxin levels in surgical patties and strips. The contamination may pose infection risks during surgical procedures.

    Product
    SEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. Convenience kits used for various procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0766-2025·2025-01-01

    EMPOWR 3D Knee Tibial Insert Package Mix-Up Causes Surgical Delays

    Encore Medical recalls EMPOWR 3D Knee Tibial Insert packages that may contain the wrong size implant (5R 16MM with 3R 14MM and vice versa), potentially delaying surgery. The recall affects 33 units nationwide.

    Product
    EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0317-2025·2025-01-01

    BORSARI Bloody Mary Mix Recalled for Undeclared Fish and Soy Allergens

    Borsari Food Company Inc is recalling BORSARI Bloody Mary Mix (32 fl. oz.) due to undeclared fish (anchovy) and soy. The product was distributed across multiple states, and consumers should not consume it.

    Product
    BORSARI Food Company Incorporated; BLOODY MARY MIX ; 32 FL. OZ; INGREDIENTS: Tomato juice, corn syrup, non-fat milk solids, orange juice, lemon juice, lime juice, cayenne pepper, vinegar, salt, garlic powder, Worcestershire sauce, prepared horseradish, maltic acid, sodium and pot
    Category
    Food
    Distribution
    25 states
  • HighFDA (Devices)·Z-0720-2025·2025-01-01

    Medline surgical procedure kits recalled due to endotoxin contamination

    Medline brand surgical procedure convenience kits in specific lots contain higher-than-expected endotoxin levels in surgical patties and strips. The contamination was found in raw materials used to produce sterile components.

    Product
    Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU CDS982901F; 2) NASAL PACK, SKU DYNJ17493G; 3) FESS PACK-POB, SKU DYNJ33520A; 4) SINUS PACK, SKU DYNJ44845G; 5) SINUS PACK, SKU DYNJ48330B; 6) ENT PACK, SKU DYNJ50572; 7) ENT PACK, SKU DYNJ53573A; 8
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0745-2025·2025-01-01

    BD FACSLyric 2L4C Flow Cytometer Power Supply Failure Recall

    BD FACSLyric 2L4C flow cytometers with specific power supplies (part 650781) may fail to power on or stay on. Potential fume inhalation could cause respiratory symptoms in laboratory staff.

    Product
    FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD FACSLyric" flow cytometer is intended for in vitro diagnostic for the following: " Immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-nm)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0161-2025·2025-01-01

    Duloxetine 30mg Capsules Recalled Due to Nitrosamine Impurity

    Breckenridge Pharmaceutical is recalling 163,883 bottles of Duloxetine 30mg capsules nationwide due to N-nitroso-duloxetine impurity above FDA-recommended limits.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0753-2025·2025-01-01

    Merlin PCS 3650 Pacemaker Programmer Software Anomaly May Cause Loss of Pacing

    A software anomaly in Abbott's Merlin PCS 3650 programmer may prevent proper finalization of leadless pacemakers, causing loss of pacing function. The issue occurs when specific actions combine with brief telemetry loss.

    Product
    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0730-2025·2025-01-01

    Abbott 20/30 Indeflator devices recalled for potential leak risk

    Abbott Vascular is recalling 20/30 Indeflator devices used in cardiovascular procedures due to potential leaks that could cause air embolism.

    Product
    20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such as balloon dilatation catheters to create and monitor pressure in the balloon.
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-0749-2025·2025-01-01

    BD FACSLyric Flow Cytometer Power Supply Failure Risk

    BD is recalling FACSLyric flow cytometer power supplies that may fail to power on or stay on, creating risks of fume inhalation and requiring patients to return for repeat biospecimen collection procedures.

    Product
    FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0759-2025·2025-01-01

    Medline ST IUD Removal Hook Recalled Due to Weak Seals and Sterility Risk

    Medline Industries is recalling 21,440 units of the ST IUD Removal Hook due to weak seals that may compromise sterility. The defect is undetectable to users and could increase infection risk.

    Product
    ST IUD REMOVAL HOOK 10" (504090), Medline Item No. I68785
    Category
    Medical Device
    Distribution
    Distributed nationwide