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.

12701–12725 of 27206

  • SevereFDA (Drugs)·D-0311-2024·2024-02-14

    Up&Up Dry Eye Relief Nationwide Recall for Non-Sterility

    Up&Up brand dry eye relief (0.5 FL OZ) distributed by Target nationwide is being recalled due to non-sterility. The FDA Class I recall affects all lots of this ophthalmic drug.

    Product
    Up&Up brand dry eye relief (Carboxymethylcellulose 0.5%) packaged in 0.5 FL OZ (15 mL) each bottles (Twin Pack), Distributed by: Target Corporation Minneapolis, MN 55403, NDC 76168-800-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0851-2024·2024-02-14

    Cardinal Health Monoject Syringes and Enteral Syringes Removed

    Cardinal Health is removing all Monoject sterile syringes and enteral syringes due to manufacturing changes and rebranding efforts. These products are distributed across the U.S. and Canada.

    Product
    Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0929-2024·2024-02-14

    BrightView Gamma Camera Detector May Fall and Injure Patients

    Philips BrightView gamma camera detectors may fall due to component failure, potentially causing patient injury including lacerations and fractures. The FDA is recalling all affected units.

    Product
    BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560279781 453560279791 453560279811 453560279801; 4x4 digit format 2170-3000A 2170-3001A 2170-3002A 2170-3003A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0304-2024·2024-02-14

    Drug Recall: Non-Sterile Lubricant Eye Drops Distributed Nationwide

    Rite Aid is recalling lubricant eye drops due to non-sterility concerns. All lots of the Carboxymethylcellulose Sodium 0.5% product are affected.

    Product
    LUBRICANT EYE DROPS (Carboxymethylcellulose Sodium 0.5%), packaged 0.5 FL OZ (15mL) bottles (Twin Pack), Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4811-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0854-2024·2024-02-14

    Cardinal Health Monoject Syringes Recalled Due to Manufacturing Changes

    Cardinal Health is removing Monoject sterile syringes in multiple sizes due to manufacturing and rebranding changes. The recall affects products distributed nationwide in the US and Canada.

    Product
    Cardinal Health Monoject, 12 mL Syringe Luer-Lock Tip Soft Pack, REF 1181200777T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0294-2024·2024-02-14

    CVS Health Lubricating Gel Drops Recalled Due to Non-Sterility

    CVS Health brand Lubricating Gel Drops are being recalled due to non-sterility concerns. The voluntary recall affects approximately 110,832 bottles distributed nationwide.

    Product
    CVS Health brand Lubricating Gel Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-712-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0295-2024·2024-02-14

    FDA Recalls Dry Eye Relief Drops Nationwide Due to Non-Sterility

    The FDA has issued a Class I recall of Dry Eye Relief eye drops sold nationwide due to non-sterility concerns. The manufacturer, Kilitch Healthcare India Limited, initiated the voluntary recall affecting 12,960 bottles.

    Product
    DRY EYE RELIEF — DRY EYE RELIEF (POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1013-2024·2024-02-14

    BD BBL Sensi Disc Ampicillin testing discs recalled for accuracy failures

    Becton Dickinson is recalling 2.3 million antibiotic susceptibility testing discs due to accuracy and quality control failures. The discs may cause delayed or incorrect test results, potentially leading to inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Ampicillin with Sulbactam 10/10 ¿g, Catalog Number 231660. Used for semi-quantitative in vitro susceptibility testing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0993-2024·2024-02-14

    FilmArray Pneumonia Panel Plus Test Kits Recalled for False Positive Results

    BioFire Diagnostics is recalling FilmArray Pneumonia Panel Plus diagnostic test kits due to a potential for false positive results. These inaccurate results could lead to incorrect pneumonia diagnoses.

    Product
    FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1042-2024·2024-02-14

    Prestige Coil System Recalled for Risk of Foreign Emboli from Corroded Delivery Pusher

    BALT USA is recalling Prestige Coil Systems due to corrosion of the delivery pusher. Solder flux residue can cause the discolored hypotube to break off and enter patient blood vessels as foreign emboli.

    Product
    The Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices are angiographically delivered through the vasculature to embolize peripheral vascular abnormalities. The devices are to be placed to create blood stasis, reduc
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Food)·F-0820-2024·2024-02-14

    Gorgonzola Cheese Product Recalled for Improper Temperature Storage

    Greco Sidari recalled Norpaco Gorgonzola Stuff Olive cheese cases distributed in Ohio, New York, and Pennsylvania due to improper temperature storage. The temperature failure could have allowed spoilage and potential pathogen growth.

    Product
    Norpaco GORGONZOLA STUFF OLIVE 1/7.5# SUPC/ITEM # 4481
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1008-2024·2024-02-14

    Brasseler dental burs recalled due to defective latching mechanism

    Brasseler USA recalls 440 dental burs due to right angle latch specification failure that prevents proper latching in dental handpieces.

    Product
    Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0977-2024·2024-02-14

    RotaFlow Centrifugal Pump Seal Defect Poses Infection Risk

    Maquet Medical Systems is recalling 1,090 RotaFlow centrifugal pumps used in heart surgery due to seal defects that could compromise sterile barriers and expose patients to infection.

    Product
    BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1037-2024·2024-02-14

    BD BBL Sensi Disc Piperacillin/Tazobactam Antibiotic Testing Discs Recalled for Accuracy Issues

    BD BBL Sensi Disc Piperacillin/Tazobactam antibiotic susceptibility testing discs are recalled due to potential quality control and accuracy failures. These failures may cause delayed or inaccurate test results, affecting patient diagnosis and antibiotic treatment selection.

    Product
    BD BBL Sensi Disc Piperacillin/Tazobactam- 100/10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231691 and 231692¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0833-2024·2024-02-14

    Ricotta cheese recalled for improper temperature control

    Greco Sidari's ricotta cheese was not held at appropriate temperatures, which could affect food spoilage and potentially support pathogen growth. The recall affects 1375 cases distributed in OH, NY, and PA.

    Product
    GRANDE RICOTTA SOPRAFFINA 6/3# SUPC/ITEM # 19535
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0861-2024·2024-02-14

    Wegmans Mini Danish Recalled for Undeclared Soy Lecithin

    Wegmans Food Markets recalls 9 oz 10-pack Assorted Mini Danish pastries (UPC 7789050815) because the product contains undeclared soy lecithin, which poses a risk to consumers with soy allergies.

    Product
    9 oz 10pk Assorted Mini Danish, bakery box with clear top (UPC 7789050815)
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-1025-2024·2024-02-14

    Antibiotic susceptibility testing discs recalled for potential accuracy failures

    Becton Dickinson's BD BBL Sensi Disc Cefuroxime testing discs may have accuracy, reproducibility, or quality-control failures in antibiotic susceptibility testing. This could delay diagnosis and lead to inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Cefuroxime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231621¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1038-2024·2024-02-14

    BD BBL Sensi Disc Rifampin Antibiotic Susceptibility Test Discs Recalled

    BD BBL Sensi Disc Rifampin antibiotic susceptibility test discs are being recalled due to potential accuracy and quality control failures. These discs are distributed domestically nationwide and internationally.

    Product
    BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231541 and 231544¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1039-2024·2024-02-14

    BD BBL Sensi Disc Antibiotic Test Discs Recalled for Accuracy Failures

    Becton Dickinson is recalling BD BBL Sensi Disc antibiotic susceptibility test discs due to potential accuracy and quality control failures that may lead to incorrect antibiotic selection and delayed diagnosis.

    Product
    BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231536 and 231539¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0844-2024·2024-02-14

    Mastro Capocollo Cured Meat Recalled for Improper Storage Temperature

    Mastro Capocollo cured meat was not held at proper temperatures, potentially allowing pathogen growth. The recall affects 1,375 cases distributed in Ohio, New York, and Pennsylvania.

    Product
    SOFINA 21202 MASTRO CAPOCOLLC 4 - 6LB SUPC/ITEM # 199694
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0985-2024·2024-02-14

    Carter-Thomason CloseSure Surgical Kit Recall: Mislabeled Component Descriptions

    CooperSurgical is recalling Carter-Thomason CloseSure System XL surgical kits due to incorrect component descriptions on packaging. The affected batch includes 127 boxes (381 total kits) with lot number 326728.

    Product
    Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard, Carter-Thomason CloseSure System, REF 733776, Contents: One (1) Carter-Thomason Suture Passer, One (1) 5 mm Pilot Guide, One (1) 10/12 mm Pilot Guide.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1022-2024·2024-02-14

    BD BBL Sensi Disc Ceftaroline test discs recalled for accuracy failures

    Becton Dickinson is recalling BD BBL Sensi Disc Ceftaroline test discs due to potential accuracy and quality control failures in antibiotic susceptibility testing. Incorrect test results may delay diagnosis and lead to inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Ceftaroline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232231¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1010-2024·2024-02-14

    PulseSpray Infusion System O-Ring Defect May Cause Medication Leaks

    Angiodynamics is recalling PulseSpray Infusion System devices due to a manufacturing defect in the rotating adaptor O-ring that may compromise seal integrity and cause medication to leak during infusion.

    Product
    PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx135x20, UPN: H787125004155, REF: 12500415; and PULSE SPRAY 5F/45/10, UPN: H787125004235, REF: 12500423.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1012-2024·2024-02-14

    BD antibiotic susceptibility testing discs recalled for accuracy failures

    Becton Dickinson is recalling BD BBL Sensi Disc Ampicillin antibiotic susceptibility testing discs due to accuracy and quality control failures that may cause delayed diagnosis or inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Ampicillin - 10 ¿g, Catalog No. 230705 and 231264; 2 ¿g, Catalog No. 231263. Used for semi-quantitative in vitro susceptibility testing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0846-2024·2024-02-14

    Potato Salad Recalled for Improper Temperature Storage During Distribution

    Resers Potato Salad Regular is being recalled due to improper temperature storage during distribution, which could potentially support pathogen growth. Affected cases were distributed to Ohio, New York, and Pennsylvania from November 2023 to January 2024.

    Product
    RESERS POTATO SALAD REGULAR 3/8# SUPC/ITEM # 0991C
    Category
    Food
    Distribution
    3 states