The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

15951–15975 of 53092

  • 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-1746-2022·2022-09-21

    Laboratory device displays incorrect sample volume guidance during setup

    A laboratory automation device's setup screen indicates minimal volume when the exact volume should be loaded, potentially causing over-diluted, under-diluted, or improperly prepared samples and false test results.

    Product
    QIAcube Connect MDx, Model No. 9003070
    Category
    Medical Device
    Distribution
    26 states
  • 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 (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V707000·2022-09-21

    2022-2023 Volkswagen Golf R and GTI radiator defect recall

    Volkswagen is recalling 2022-2023 Golf R and Golf GTI vehicles because the radiator may not be properly attached to the intercooler, potentially causing coolant leaks, engine overheating, and fire risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN GOLF R, GTI
    Category
    Vehicle
    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 (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
  • HighNHTSA·22V703000·2022-09-19

    2016-2023 Kia Sorento and Sportage tow hitch electrical fire hazard recall

    Kia is recalling certain 2016-2023 Sorento and 2017-2022 Sportage models with factory or dealer-installed tow hitch harnesses. Moisture and debris on the harness module can cause an electrical short and fire while parked or driving.

    Product
    KIA — KIA SORENTO, SPORTAGE, SORENTO HYBRID, SORENTO PHEV
    Category
    Vehicle
    Distribution
    Distributed nationwide