The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

22451–22475 of 88183

  • 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 (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…
    Category
    Medical Device
    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 (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 (Devices)·Z-1745-2022·2022-09-21

    INOmax DSIR Delivery System incompatible with upgraded Leoni Plus ventilator

    The INOmax DSIR nitric oxide delivery system is incompatible with the 2021-upgraded Leoni Plus ventilator. Without proper connection including a required one-way valve, patients may receive excessive nitric oxide.

    Product
    INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, Model Number: 10007
    Category
    Medical Device
    Distribution
    0 states
  • 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-1722-2022·2022-09-21

    ICU Medical Recalls Intravascular Connectors for Manufacturing Defect

    ICU Medical is recalling approximately 5.8 million MicroClave Clear Connectors used in IV administration due to a manufacturing defect that creates a visible gap between the connector housing.

    Product
    MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroClave Clear Neutral Connector, Approx Priming Volume: 0.04 mL. Accessory for Intravascular Administration Set
    Category
    Medical Device
    Distribution
    53 states
  • 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1726-2022·2022-09-21

    GXL Acetabular Liners Recalled Due to Improper Packaging and Accelerated Wear

    Exactech is recalling 136 GXL acetabular liners used in hip implants due to non-conforming packaging that may cause accelerated wear. The devices were distributed worldwide to multiple countries.

    Product
    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 15 DEGREE LINER 22MM SZ C, REF 132-22-03 b. ACUMATCH 15 DEGREE LINER 28MM SZ D, REF 13-28-04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1723-2022·2022-09-21

    ICU Medical IV Connector Extension Set Recalled for Manufacturing Defect

    ICU Medical is recalling intravascular administration set connectors due to a manufacturing defect that creates a visible gap in the connector housing. The defect affects approximately 5.8 million units distributed nationwide and internationally.

    Product
    6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascular administration set.
    Category
    Medical Device
    Distribution
    53 states
  • 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 (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 (Drugs)·D-1519-2022·2022-09-21

    Semaglutide/Cyanocobalamin Injectable Syringes Recalled Due to Sterility Assurance Concerns

    Carolina Infusion is recalling Semaglutide/Cyanocobalamin injectable syringes nationwide due to lack of assurance of sterility. Patients should contact their healthcare provider if they received this product.

    Product
    Semaglutide/Cyanocobalamin 5/2 MG/ML Injectable, 0.2 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1530-2022·2022-09-21

    TRI-MIX 30/2/20 Injectable Recalled for Lack of Sterility Assurance

    Carolina Infusion is recalling TRI-MIX 30/2/20 Injectable due to lack of assurance of sterility. Multiple lots were distributed nationwide to healthcare providers.

    Product
    TRI-MIX 30/2/20 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1737-2022·2022-09-21

    Subdermal Needle Electrodes Recalled Due to Burn Risk During MRI Procedures

    Technomed Europe is recalling disposable subdermal needle electrodes because patients may suffer burns if electrodes are left in place during MRI scanning. The manufacturer failed to provide adequate safety information in the device instructions.

    Product
    Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.
    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-1514-2022·2022-09-21

    Injectable Anesthetic Solution Recalled for Lack of Sterility Assurance

    Pine Pharmaceuticals is recalling Bupivacaine and Lidocaine injectable solutions for eye anesthesia due to lack of assurance of sterility. The product was distributed to direct accounts in four states.

    Product
    Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar Injection; packaged in a) 10 mL prefilled syringe, Item# 803, barcode 6919408031; b) 5 mL prefilled syringe, Item# 933, barcode 6919409331, Rx only, Pine Pharmaceuticals, 355 Riverwalk…
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Food)·F-1734-2022·2022-09-21

    GNC Vitamin B-6 supplement mislabeled; bottles contain Pycnogenol instead

    GNC Vitamin B-6 100mg dietary supplement bottles actually contain Pycnogenol due to a filling line error. The product was distributed across all 50 US states and multiple international locations.

    Product
    GNC Vitamin B-6 100mg 100 VEGETARIAN TABLETS DIETARY SUPPLEMENTS Distributed by: General Nutrition Corporation Pittsburgh, PA 15222 UPC 0 48107 20584 3
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1535-2022·2022-09-21

    Triamcinolone Acetonide Cream Recalled Due to Manufacturing Quality Defects

    Direct Rx is recalling Triamcinolone Acetonide cream 0.1% due to manufacturing quality deviations that resulted in gritty texture and lack of effectiveness. The affected lot is 12JY2216, expiring February 29, 2024.

    Product
    TRIAMCINOLONE ACETONIDE — TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE CREAM)
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1736-2022·2022-09-21

    Steris SixCess Challenge Pack Recalled for Incorrect Chemical Indicators

    Steris Corporation is recalling 619 boxes of Verify SixCess Challenge Pack due to incorrect chemical indicators in the packaging. This sterilization validation device is distributed across 31 U.S. states.

    Product
    Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.
    Category
    Medical Device
    Distribution
    31 states
  • ModerateFDA (Drugs)·D-1511-2022·2022-09-21

    OTC Magnesium Citrate Laxative Recalled for Manufacturing Process Deviations

    Magnesium citrate saline laxative products branded as CITROMA and multiple retail equivalents are subject to a Class II recall due to manufacturing process deviations. The voluntary recall affects millions of bottles distributed nationwide and internationally.

    Product
    CITROMA — CITROMA (MAGNESIUM CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1729-2022·2022-09-21

    GXL Acetabular Liners Recalled Due to Non-Conforming Packaging

    Exactech is recalling certain GXL acetabular liners packaged in non-conforming bags that may cause accelerated wear of the hip implant component. No injuries have been reported.

    Product
    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER, NEUTRAL, 28MM ID, GROUP 1 CUPS, REF 130-28-51 b. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 2 CUPS, REF 130-32-52 c. NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 3 CUPS…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1512-2022·2022-09-21

    FDA Recalls Citroma Magnesium Citrate Laxative for Manufacturing Deviations

    Vi-Jon is recalling Citroma magnesium citrate oral laxative due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects units distributed nationwide and internationally.

    Product
    CITROMA — CITROMA (MAGNESIUM CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1733-2022·2022-09-21

    GXL Hip Implant Liners Recalled for Packaging Defect Risk

    Exactech is recalling specific GXL acetabular polyethylene hip implant liners because non-conforming packaging may cause accelerated wear. The company has distributed 4,956 affected devices worldwide.

    Product
    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42; b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 44, REF 106-22-44; c. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED…
    Category
    Medical Device
    Distribution
    Distributed nationwide