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.

11476–11500 of 22152

  • HighFDA (Devices)·Z-1805-2024·2024-05-22

    Medtronic Venous Cannulae Recalled for Unsealed Sterile Packaging

    Medtronic Perfusion Systems is recalling 17,221 units of venous cannulae due to potential for unsealed sterile packaging. The devices were distributed worldwide to healthcare facilities.

    Product
    Medtronic Venous Cannulae: a) DLP¿ 20 Fr. Malleable Single Stage Venous Cannula, Model Number 68120, b) DLP¿ 24 Fr. Malleable Single Stage Venous Cannula, Model Number 68124, c) DLP¿ 28 Fr. Malleable Single Stage Venous Cannula, Model Number 68128, d) DLP¿ 30 Fr. Malleab
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1800-2024·2024-05-22

    Medtronic Aortic Root Cannulae and Cardioplegia Needles Recalled for Unsealed Sterile Packing

    Medtronic is recalling aortic root cannulae and cardioplegia needles used in cardiac surgery due to potential unsealed sterile packaging. Approximately 2,622 units were distributed worldwide.

    Product
    Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP¿ 9 Ga (11 Fr) Aortic Root Cannula, Model Number 24009; b) DLP¿ 16 Ga (5 Fr) Cardioplegia Needle Neonatal 0.64 cm (1/4 in) Tip Length, Model Number 11316; c) M+AR" 14 Ga (7 Fr) Aortic Root Cannula with Flow-
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1806-2024·2024-05-22

    MEDLINE namic Cardiovascular Kit Variants Recalled for Lack of Sterility

    Medline Industries recalls multiple namic CONVENIENCE KIT variants used in cardiovascular procedures due to lack of sterility assurance. Approximately 570 units distributed nationwide may pose infection risk.

    Product
    namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIFOLD KIT ON WITH NAMIC DT & WASTE MANAGEMENT, REF 60070582; c) LEFT HEART KIT, REF 60071822; d) LEFT HEART KIT, REF 60080085; e) CONVENIENCE KIT, REF 60100055; f) CONVENIENCE KIT, REF 60101041;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1789-2024·2024-05-22

    Ossur RHEO Knee XC Prosthetic Components Recall Due to Firmware Issues

    Ossur is recalling 107 RHEO Knee XC prosthetic components due to firmware issues that may cause unintended device shutdown or warnings, risking patient falls.

    Product
    RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1826-2024·2024-05-22

    Sophysa Pressio Ventricular ICP Monitoring Kit Recalled for Manufacturing Defect Causing CSF Leakage

    Sophysa is recalling the Pressio Ventricular Intracranial Pressure Monitoring Kit due to a manufacturing defect that causes cerebrospinal fluid leakage. An undetected leak during implantation could pose an infectious risk to patients.

    Product
    The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure and temperature with tunneling (PSO-VTT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage applic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1787-2024·2024-05-22

    Prosthetic knee recalled due to firmware issues causing potential device shutdown

    Ossur H/F is recalling RHEO KNEE prosthetic knee components due to firmware issues that could cause unintended warnings and device shutdown, creating fall risk for users.

    Product
    RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1833-2024·2024-05-22

    Cook Medical EchoTip Ultra needle recalled due to elevated bacterial endotoxin levels

    Cook Medical is recalling EchoTip Ultra endoscopic ultrasound access needles that may contain elevated bacterial endotoxin levels. The affected units were distributed internationally.

    Product
    EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1827-2024·2024-05-22

    Philips Patient Information Center iX Software: Event Catalog Data Loss Recall

    Philips Patient Information Center iX software version 4.x fails to properly save or transfer event catalog information, risking data loss in healthcare facilities. The FDA issued a Class II recall affecting 358 units globally.

    Product
    Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0497-2024·2024-05-22

    Antibiotic Cefdinir Oral Suspension Recalled Over Foreign Material

    Lupin Pharmaceuticals is recalling Cefdinir for Oral Suspension due to foreign material found in reconstituted bottles. This FDA Class II recall affects 17,040 bottles distributed nationwide.

    Product
    CEFDINIR — CEFDINIR (CEFDINIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1818-2024·2024-05-22

    Free T3 Reagent Pack May Produce Inaccurate Test Results

    QUIDELORTHO's VITROS Free T3 Reagent Packs may produce falsely elevated test results, potentially affecting thyroid function diagnoses and patient management. Eight lot numbers with expiry dates through August 2024 were distributed worldwide.

    Product
    VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (EDTA or heparin). Product Code: 131 5589
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0498-2024·2024-05-22

    Losartan Potassium and Hydrochlorothiazide Tablets Recalled for Foreign Plastic Contamination

    Macleods Pharma USA is recalling Losartan Potassium and Hydrochlorothiazide tablets (50 mg/12.5 mg, lot BLK2304A) due to the presence of a plastic-like foreign substance. The recall affects 1,048 bottles distributed nationwide.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1810-2024·2024-05-22

    Baxter Spectrum IQ Infusion Pump Recalled for Potential Front Panel Cracks

    Baxter Healthcare Corporation has recalled 9 Spectrum IQ Infusion Pumps due to potential cracks on the front panel mount. Units distributed in Ohio and Wisconsin are affected.

    Product
    Spectrum IQ Infusion pump, Product Code 357009
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1804-2024·2024-05-22

    Medtronic Suction Tubes Recalled for Potential Unsealed Sterile Packaging

    Medtronic is recalling multiple models of suction tubes due to potential for unsealed sterile packing, which could compromise device sterility. Affected customers should refer to the official FDA recall notice for lot details.

    Product
    Medtronic Suction Tubes: a) DLP¿ Suction Tube 6-Fr. Shaft with Frazier Tip, Model Number: 10050, b) DLP¿ Suction Tube 6-Fr. Shaft with 10-Fr. Soft Tip, Model Number: 10052, c) DLP¿ Suction Tube 6-Fr. Shaft with 10-Fr. Soft Tip, Model Number: 10053, d) DLP¿ Suction Tube
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1243-2024·2024-05-22

    Sysco Classic Riced Cauliflower Recalled for Listeria Contamination

    CN Frozen Foods is recalling Sysco Classic Riced Cauliflower sold in Texas due to Listeria monocytogenes contamination detected during testing. No illnesses have been reported.

    Product
    Sysco Classic Riced Cauliflower packed in a 4lb plastic bag (6 units of 4 lb. per carton box).
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1807-2024·2024-05-22

    Medline Namic Fluid Delivery Set Recalled for Lack of Sterility Assurance

    Medline Industries is recalling Namic Fluid Delivery Sets (lot 0000113381) because they lack sterility assurance, which could allow contamination during medical procedures.

    Product
    Namic FLUID DELIVERY SET, REF 91300040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1824-2024·2024-05-22

    Syntel Silicone Thrombectomy Catheter recalled due to guide tip detachment risk

    LeMaitre Vascular is recalling 5,604 units of Syntel Silicone Thrombectomy Catheters worldwide because the guide tip can become damaged and detach during use.

    Product
    Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1830-2024·2024-05-22

    Philips Ingenia 3.0T MR Systems May Not Warn of Low Ventilation Settings

    Philips Ingenia 3.0T MR systems with software R5.7.1 may fail to warn about low ventilation, potentially causing patient overheating or burning sensations. 19 units affected worldwide.

    Product
    Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782117
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1798-2024·2024-05-22

    Medtronic Tourniquet Sets recalled for potential unsealed sterile packing

    Medtronic is recalling 1760 tourniquet kits due to potential for unsealed sterile packing. These surgical devices may have compromised sterilization barriers.

    Product
    Medtronic Tourniquet Sets: a) DLP¿ 5.5 in (14.0 cm) Tourniquet Kit, Model Number 79004, b) DLP¿ 7 in (17.8 cm) Tourniquet Kit, Model Number 79009
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1835-2024·2024-05-22

    Cardinal Health Curity Adhesive Bandages Recalled for Latex Contamination

    Cardinal Health is recalling Curity Flexible Adhesive Bandages (Model 44102, Lot #A14722) due to potential contamination with latex adhesive residual. The hypoallergenic product was distributed nationwide to approximately 2,000 packages.

    Product
    CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9.5 cm), Model 44102, Sterile, Hypoallergenic.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1822-2024·2024-05-22

    Novalung Sensor Box Recalled for Flow Measurement Technical Failure

    Fresenius is recalling 88 Novalung sensor boxes for error messages affecting flow measurement. The defect impacts measurement capabilities in a life-support system used for acute respiratory and cardiac failure patients.

    Product
    Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blood in a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1797-2024·2024-05-22

    Medtronic Left Heart Vent Catheters recalled for unsealed sterile packaging

    Medtronic recalls over 13,000 Left Heart Vent Catheter units due to potential for unsealed sterile packing. Affected devices distributed worldwide.

    Product
    Medtronic Left Heart Vent Catheters: a) DLP¿ Intracardiac Sump 20 Fr, Model Number 12012, b) DLP¿ Left Heart Vent Catheter 10 Fr., Model Number 12008, c) DLP¿ Left Heart Vent Catheter 13 Fr., Model Number 12001, d) DLP¿ Left Heart Vent Catheter 13 Fr., Model Number 12113
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1791-2024·2024-05-22

    TriMed Threaded IM Nail System Recalled for Driver-Socket Defect

    TriMed Inc. is recalling 142 units of Threaded IM Nails with an out-of-specification driver-socket that could prevent proper surgical nail fixation and torque application.

    Product
    TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm, 65mm, TI, Ref: IMN3.6-65 T, Non Sterile, MD, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0499-2024·2024-05-22

    Prescription Corticosteroid Injectable Recalled for Particulate Matter

    Sagent Pharmaceuticals recalls methylprednisolone acetate injectable suspension due to potential black particulates in the drug product. Four affected lots were distributed nationwide.

    Product
    METHYLPREDNISOLONE ACETATE — METHYLPREDNISOLONE ACETATE (METHYLPREDNISOLONE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1828-2024·2024-05-22

    CoFlex NL Sterile Bandages Recalled for Packaging Seal Gaps

    Andover Healthcare Inc. is recalling CoFlex NL sterile flexible cohesive bandages (model 5400S) due to packaging seal gaps that could compromise product sterility. No illnesses have been reported.

    Product
    Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)
    Category
    Medical Device
    Distribution
    Distributed nationwide