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.

11451–11475 of 27206

  • HighFDA (Devices)·Z-1819-2024·2024-05-22

    VITROS Free T3 Calibrators recalled due to positive bias in thyroid test results

    QUIDELORTHO is recalling VITROS Free T3 Calibrators used in thyroid testing because they may produce elevated results that could lead to incorrect patient diagnosis or delayed care.

    Product
    VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Free T3 Reagent Pack for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (EDTA or heparin). Product Code: 111 2820
    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-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-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-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 (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 (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-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-1821-2024·2024-05-22

    APTUS 2.8 TriLock Bone Fixation Screws Recalled for Incorrect Length

    Medartis Inc. is recalling APTUS 2.8 TriLock Screws (lot 24377397) because some units are 16mm long instead of the specified 22mm, which could compromise bone fixation stability.

    Product
    APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.
    Category
    Medical Device
    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
  • 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 (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-1796-2024·2024-05-22

    Medtronic Arteriotomy Cannula Recall Due to Potential Unsealed Sterile Packing

    Medtronic is recalling 7,935 units of I.M.A. Arteriotomy Cannula Model 31001 worldwide due to potential for unsealed sterile packing. Affected healthcare providers should verify lot numbers against inventory.

    Product
    Medtronic I.M.A. Cannulae: DLP¿ 1 mm Arteriotomy Cannula, Model Number 31001
    Category
    Medical Device
    Distribution
    0 states
  • 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-1825-2024·2024-05-22

    Sophysa Pressio Ventricular Intracranial Pressure Monitoring Kit Recall Due to CSF Leakage Risk

    Sophysa is recalling the Pressio Ventricular Intracranial Pressure Monitoring Kit due to manufacturing defects causing cerebrospinal fluid leakage from the catheter. Undetected leaks during implantation could result in infection risk to patients.

    Product
    The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure with tunneling (PSO-VT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application. Model/Cat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1237-2024·2024-05-22

    Organic Yogi Echinacea Immune Support Tea Recalled for Pesticide Residues

    East West Tea Company is recalling Organic Yogi Echinacea Immune Support tea bags nationwide due to pesticide residues detected above FDA action levels.

    Product
    Organic Yogi Echinacea Immune Support, Caffeine Herbal Supplement, Serving Size 1 tea bag, 16 tea bags per pack, 4 packs per box. UPC on box: 0 76950 45010 3. CASE GTIN: 60076950450105. East West Tea Company, LLC Eugene, OR Yogi Echinacea Immune Support, Caffeine Herbal Suppleme
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1801-2024·2024-05-22

    Medtronic Cardioplegia Adapters recalled for potential unsealed sterile packaging

    Medtronic is recalling seven models of cardioplegia adapters due to potential unsealed sterile packaging, which could compromise equipment sterility in cardiac surgery. No illnesses have been reported.

    Product
    Medtronic Cardioplegia Adapters: a) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25009, b) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25010, c) DLP¿ 30.5 cm (12 in) Multiple Perfusion Set, Model Number 14003,
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0495-2024·2024-05-22

    Gordofilm Wart Remover Recalled Due to Manufacturing Deviations

    Gordofilm Wart Remover by Gordon Laboratories is being recalled nationwide due to Current Good Manufacturing Practice (cGMP) deviations. The FDA classified this as a Class II recall on May 13, 2024.

    Product
    Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars, Gordon Laboratories, Upper Darby PA 19082, NDC 10481-3009-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0501-2024·2024-05-22

    OTC Magnesium Citrate laxative recalled for microbial contamination

    Meijer Magnesium Citrate Saline Laxative is being recalled due to microbial contamination. Lot A81834 (expiration 1/31/2026) was distributed nationwide; consumers should stop using the product.

    Product
    MAGNESIUM CITRATE — MAGNESIUM CITRATE (MAGNESIUM CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0500-2024·2024-05-22

    Magnesium Citrate Laxative Recalled for Bacterial Contamination

    CVS Health Magnesium Citrate Saline Laxative Oral Solution is being recalled nationwide due to microbial contamination with Acetobacter nitrogenifigens bacteria in lot A81506.

    Product
    MAGNESIUM CITRATE — MAGNESIUM CITRATE (CVS MAGNESIUM CITRATE ORAL SOLUTION - GRAPE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1241-2024·2024-05-22

    Multiple Brands Whole Milk Recalled for Potential Potable Water Content

    Multiple brands of Hiland and store-brand whole milk sold in Kansas and Missouri are being recalled because they may contain potable water, which is a composition concern.

    Product
    1. Country Club, Price Chopper, Good & Gather, Hiland, Belfonte, Great Value, Hen House Vitamin D Whole Milk, 1 gallon. 2. Country Club, Price Chopper, Good & Gather, Best Choice, Good Nature Family Farms Vitamin D Whole Milk, Half Gallon. 3. Belfonte, Hiland Vitamin D Whole Milk
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-1231-2024·2024-05-15

    Chocolate Ice Cream Cookie Sandwiches Recalled for Undeclared Allergens

    Belgian Yummies recalls Chocolate Ice Cream Cookie Sandwiches distributed in Florida due to undeclared allergens: milk, eggs, wheat, peanuts, and tree nuts. Consumers with allergies should not consume this product.

    Product
    Chocolate Ice Cream Cookie Sandwich. Sandwiches packaged in a gold or clear bags. 50 sandwiches per case and weighting 4oz each sandwich.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0486-2024·2024-05-15

    Sapropterin Dihydrochloride Powder for Oral Solution Recalled Due to Sub-Potency

    Dr. Reddy's Laboratories is recalling 2,402 cartons of Sapropterin Dihydrochloride Powder 100mg due to sub-potency associated with powder discoloration. The affected lot (T2200352) was distributed nationwide.

    Product
    Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-477-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1233-2024·2024-05-15

    Belgian Yummies Salted Caramel Ice Cream Cookie Sandwiches recalled for undeclared allergens

    Belgian Yummies is recalling Salted Caramel Ice Cream Cookie Sandwiches distributed in Florida due to undeclared allergens including milk, eggs, soy, wheat, peanuts, and tree nuts. The recall affects 254 units.

    Product
    Salted Caramel Ice Cream Cookie Sandwich. Sandwiches packaged in a gold or clear bags. 50 sandwiches per case and weighting 4oz each sandwich.
    Category
    Food
    Distribution
    0 states