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.

1426–1450 of 26417

  • HighFDA (Devices)·Z-1383-2026·2026-02-25

    Bronchoscopy System Software Bug Could Cause Unexpected Robotic Arm Positioning

    Auris Health MONARCH Platform bronchoscopy systems are affected by a software defect where the application may reinitialize to an incorrect position after restart, potentially causing the robotic arm to contact the patient's airway.

    Product
    MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1373-2026·2026-02-25

    FDA Recalls Olympus Thunderbeat 5mm Surgical Instruments Due to Adverse Events

    Olympus Corporation is recalling 4,181 units of the Olympus Thunderbeat 5mm surgical device due to continued reports of adverse events. The device was distributed across the U.S., Brazil, Canada, Germany, Mexico, and Japan.

    Product
    Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1397-2026·2026-02-25

    Medline surgical kits recalled for potential sterility compromise due to calibration issues

    Medline is recalling 4,757 surgical kits and packs due to calibration issues with sterilization equipment that could affect sterility assurance. No illnesses or injuries have been reported.

    Product
    Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C; 3) KIT PLASTIC INSERT TISSUE EXPA, Model Number: DYKMBNDL158; 4) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170; 5) KIT PLASTIC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1382-2026·2026-02-25

    Olympus Thunderbeat Surgical Instrument Recall Due to Adverse Events

    Olympus is recalling approximately 1,538 Thunderbeat surgical instruments due to continued reports of adverse events. Affected devices are being removed from distribution.

    Product
    Olympus Thunderbeat 5 mm, 10 cm, Inline Grip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1388-2026·2026-02-25

    Medline Convenience Kits Sterility Assurance Recall

    Medline is recalling 3,561 convenience kits due to calibration issues with sterilization equipment that may compromise sterility assurance. No illnesses have been reported.

    Product
    Medline Convenience Kits: 1) ENDO KIT W/SYRINGE, Model Number: DYKE1743; 2) BGMC ANGIOGRAPHY PACK-LF, Model Number: DYNJ0800934D; 3) GENERAL ENDO PACK-LF, Model Number: DYNJ0842873J; 4) OR ANGIO PACK-LF, Model Number: DYNJ43415C; 5) ANGIO PACK II, Model Number: DYNJ44066
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1384-2026·2026-02-25

    Medline convenience kits recalled for sterilization equipment calibration issues

    Medline Industries recalls 551 sterilization and anesthesia convenience kits due to calibration defects in manufacturing equipment that may compromise product sterility assurance.

    Product
    Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number: DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Number: DYNJ905567A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1399-2026·2026-02-25

    Medline Convenience Kits Recalled Due to Sterilization Calibration Issues

    Medline Industries recalls 154,427 sterilized medical convenience kits due to calibration issues with sterilization and packaging equipment that may impact sterility assurance. No illnesses have been reported.

    Product
    Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326A; 3) DRAWER #5, Model Number: ACC010475; 4) DRAWER 1 NEURO CART, Model Number: ACC010542; 5) DRAWER 2 NEURO CART, Model Number: ACC01054
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1389-2026·2026-02-25

    Medline surgical and catheterization kits recalled for sterilization calibration issues

    Medline is recalling 30,958 Convenience Kits for surgical and catheterization procedures due to calibration issues with sterilization equipment that could compromise sterility assurance levels.

    Product
    Medline Convenience Kits: 1) OR ARTERIOGRAM, Model Number: CDS985094F; 2) KIT SURG ONC LAP DIAG/CV CATH, Model Number: DYKMBNDL153; 3) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4A; 4) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4B; 5) VEIN PROCEDURE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1419-2026·2026-02-25

    Medical Device Surgical Kits Recalled for Sterilization Equipment Calibration Issues

    Medline is recalling 31 models of surgical instrument kits due to calibration issues with sterilization equipment that could affect sterility assurance. The recall affects approximately 7,725 units distributed nationwide.

    Product
    Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431K; 3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431O; 4) KIT ROBOTICS GYN, Model Number: DYKMBNDL109A; 5) KIT ROBOTICS UROLOGY PROSTA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1403-2026·2026-02-25

    Medline Convenience Kits Recalled Due to Potential Sterility Compromise

    Medline Industries is recalling convenience kits due to calibration problems with sterilization equipment that could affect whether devices remain sterile.

    Product
    Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1324-2026·2026-02-18

    Reprocessed Diagnostic Ultrasound Catheters Recalled for Residual Particles

    Reprocessed Biosense Webster SOUNDSTAR eco diagnostic ultrasound catheters may contain residual particles that could cause blood clots or infection. Medline Industries is recalling 94 units distributed nationwide.

    Product
    Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE Systems 10439072RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on Siemens Systems 10438577RH; Bios
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1320-2026·2026-02-18

    Reprocessed diagnostic catheters recalled for residual material contamination

    Medline Industries recalls reprocessed Abbott diagnostic catheters that may contain particles of residual material. Use could cause infection, inflammatory response, blood clots, or embolism.

    Product
    Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerable Diagnostic Catheter 10 Elec. 2-5-2mm 81105RH 81172RH; Abbott Inquiry Steerable Diagnostic Catheter 20 Elec. 2-10-2mm 81202RH; Abbott Inquiry Steerable Diagnostic Catheter 4 Elec. 5mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0488-2026·2026-02-18

    Carrot Top Kitchens Cherry Pepper Hummus Recalled for Undeclared Sesame

    Carrot Top Kitchens is recalling Cherry Pepper Hummus because it contains undeclared sesame. Consumers with sesame allergies face potential allergic reactions.

    Product
    Carrot Top Kitchens Cherry Pepper Hummus; contains chickpeas, tahini, pickled cherry peppers, vinegar, garlic, salt; 8 oz.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·H-0486-2026·2026-02-18

    Carrot Top Kitchens Hummus Recalled for Undeclared Sesame

    Carrot Top Kitchens Sundried Tomato and Caper Hummus contains undeclared sesame. This 8-ounce product poses a health risk to consumers with sesame allergies.

    Product
    Carrot Top Kitchens Sundried Tomato and Caper Hummus; contains chickpeas, sundried tomatoes, tahini, capers, vinegar, salt; 8 oz.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1322-2026·2026-02-18

    Reprocessed electrophysiology catheters recalled for residual material contamination

    Medline Industries is recalling 48 units of reprocessed St. Jude diagnostic electrophysiology catheters due to residual material that may cause systemic infection, blood clots, or embolism.

    Product
    Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 2-5-2mm 401211RH 401222RH 401223RH 401226RH 401227RH 401260RH 401261RH 401306RH 401309RH 401312RH 401430RH 40143
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1321-2026·2026-02-18

    Reprocessed Livewire Electrophysiology Catheters Recalled for Contamination Risk

    Medline Industries is recalling reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters nationwide due to potential contamination with residual material particles that may cause serious infections or blood clots.

    Product
    Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire Steerable Electrophysiology Catheter,10 Elec. 2-5-2mm 401582RH 401940RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-10-2mm 401904RH; Livewire Steerable Electrophysiology Cath
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1325-2026·2026-02-18

    Reprocessed Siemens ACUSON AcuNav Ultrasound Catheters Recalled for Particle Contamination

    Medline Industries is recalling 511 reprocessed Siemens ACUSON AcuNav ultrasound catheters due to residual material particles. These particles may cause systemic infection, blood clots, or embolism.

    Product
    Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Systems 10135910RH; 10043342RH ACUSON AcuNav Ultrasound Catheter, Use on Siemens Systems 10135936RH, 08255790RH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1323-2026·2026-02-18

    Medline Reprocessed ICE Catheters Recalled for Residual Material

    Medline Industries is recalling 650 units of ReNewal Reprocessed ViewFlex Xtra ICE Catheters due to contamination with residual material particles. These defective devices pose a risk of serious infection and life-threatening blood clots.

    Product
    Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F x 90cm D087031RH 20197344019554¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1319-2026·2026-02-18

    Medline Reprocessed Cardiac Catheters Recalled for Particle Contamination Risk

    Medline reprocessed cardiac catheters may contain residual material particles, risking systemic infection, blood clots, and embolism. Affected units should be immediately quarantined and returned.

    Product
    Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes 2-8-2mm Spacing w/AutoID w/ EZ Steer BD710DF282CRH; Webster CS Catheter 10 Electrodes, 2-8-2mm Spacing w/ EZ Steer BD710DF282RRH BD710FJ282RRH; Webster CS Catheter 10 Electrodes, 2-8-2mm S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0353-2026·2026-02-18

    Injectable drug recalled for temperature abuse during storage

    UDENYCA (pegfilgrastim-cbqv) injection is being recalled because 116 cartons of Lot 2199821 were stored at room temperature instead of required refrigerated conditions.

    Product
    UDENYCA — UDENYCA (PEGFILGRASTIM-CBQV)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0487-2026·2026-02-18

    Carrot Top Kitchens White Truffle Hummus Recalled Due to Undeclared Sesame

    Carrot Top Kitchens is recalling White Truffle Hummus distributed in New York because it contains undeclared sesame. Consumers with sesame allergies should not consume this product.

    Product
    Carrot Top Kitchens White Truffle Hummus; contains chickpeas, tahini, truffle oil, lemon, salt; 8 oz.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·H-0491-2026·2026-02-18

    Kirkland Signature mini beignets recalled for undeclared hazelnut

    Costco is recalling Kirkland Signature Mini Beignets (item #1181272) because they contain undeclared hazelnut, a common allergen. Approximately 8,073 packages were distributed across 24 US states.

    Product
    Kirkland Signature Costco item #1181272 Mini Beignets filled with Caramel 22CT. UPC 000011 812722. Product is packaged in a clear clamshell container. ALLERGENS INFORMATION: CONTAINS WHEAT, EGG, MILK, SOY. Distributed by Costco Wholesale Corp. PO Box 34535 Seattle, WA.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0329-2026·2026-02-18

    Testosterone and Triamcinolone Sterile Pellets Recalled for Potential Metal Contamination

    F.H. INVESTMENTS (Asteria Health) is recalling Testosterone 200mg and Triamcinolone Acetonide 40mcg sterile pellets nationwide due to potential metal particulate contamination.

    Product
    Testosterone 200mg, Triamcinolone Acetonide 40mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6200-43.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0316-2026·2026-02-18

    Testosterone Pellets Recalled Due to Potential Metal Contamination

    Asteria Health is recalling testosterone pellets nationwide due to potential metal particulate matter in the product. Consumers should stop using affected lots and contact their healthcare provider.

    Product
    Testosterone, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1012-32.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0325-2026·2026-02-18

    Testosterone Injectable Pellets Recalled for Potential Metal Particulate Matter

    Asteria Health is recalling one lot of testosterone pellets due to potential presence of metal particulate matter. Affected patients should contact their healthcare provider.

    Product
    Testosterone, 303 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1303-01.
    Category
    Drug
    Distribution
    Distributed nationwide