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.

13976–14000 of 27206

  • HighFDA (Devices)·Z-0352-2024·2023-11-29

    Roche Tina-quant D-Dimer Test System Recalled for Inaccurate Results

    Roche is recalling Tina-quant D-Dimer Test System kits because they produce elevated results when used with lithium-heparin plasma samples, potentially affecting diagnostic accuracy.

    Product
    Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400 plus), 08105618190 - (cobas c 303 and 503)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0110-2024·2023-11-29

    Hand Sanitizer Recalled for Chemical Contamination Above Specifications

    Integrity Biochem 70% alcohol hand sanitizer recalled due to acetal and acetaldehyde contamination above USP limits. The 55-gallon drums distributed in Oklahoma may not meet safety standards.

    Product
    Integrity Biochem HSC70-LV, Alcohol Antiseptic 70%, Hand Sanitizer, Lavender Scented Topical Gel 208.19L (55 gallons) drum, Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA, NDC: 77512-047-03
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0399-2024·2023-11-29

    ORION Robotic Arm Recalled for Sudden Acceleration and Collision Risk

    The FDA recalls ORION robotic positioning arms used in radiation and radiology due to sudden acceleration or unintended movement that could cause patient collision with treatment room equipment. No injuries reported.

    Product
    ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00009
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0371-2024·2023-11-29

    Compress Device Anchor Plugs recalled due to metal burrs

    Biomet is recalling Compress Device Segmental Anchor Plugs due to metal burrs in transverse holes that may prevent drill or pins from passing through, potentially extending surgical time.

    Product
    Compress Device Segmental Anchor Plug, 12 MM -For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178402
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0340-2024·2023-11-29

    Mobile Airway Scope Recalled Due to Unvalidated Drying Process

    Aizu Olympus has recalled 33 Mobile Airway Scope units due to an unvalidated air drying process. Some repaired units had wet channels, creating a potential risk of contamination and infection.

    Product
    Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: MAF-DM2, MAF-GM, MAF-GM2, MAF-TM, MAF-TM2.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0356-2024·2023-11-29

    Stryker Sage PrimaFit Female Urine Management Systems recalled for undeclared latex adhesive

    Sage Products is recalling approximately 174,960 Stryker Sage PrimaFit External Urine Management Systems in three lots because a small percentage may contain tape with undeclared natural rubber latex adhesive.

    Product
    stryker Sage PrimaFit External Urine Management System for the Female Anatomy
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0338-2024·2023-11-29

    Tracheal Fiberscope Airway Management Devices Recalled for Inadequate Channel Drying

    Aizu Olympus is recalling 65 tracheal fiberscope units worldwide due to an unvalidated air drying process. Moisture remaining in device channels after repair could allow contamination and pose an infection risk.

    Product
    Tracheal fiberscope-airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: LF-DP, LF-GP, LF-TP.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0368-2024·2023-11-29

    Curaplex Manual Resuscitators Recalled for Potential CO2 Rebreathing Risk

    SunMed Holdings is recalling Curaplex manual resuscitators with integrated manometers due to a backwards leak in the patient valve that allows carbon dioxide rebreathing. All units manufactured from September 2018 to present and distributed nationwide are affected.

    Product
    Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Curaplex Adult Premium BVM with Bag Reservoir, Manometer, Filter, Peep Valve & Mask, REF # 2442-BVMPAD; 2. Curaplex Child Premium BVM with Bag Reservoir, Manometer, 2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0327-2024·2023-11-29

    Bronchoscopes Recalled Due to Inadequate Air Drying Process

    Aizu Olympus recalls bronchoscopes due to unvalidated air drying process. Some returned units after repair contain water in channels, creating infection risk.

    Product
    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0464-2024·2023-11-29

    Asenzya Hot & Spicy Cajun Style Seasoning recalled for undeclared sesame

    Asenzya Hot & Spicy Cajun Style Seasoning may contain undeclared sesame allergen. The recall affects 6,930 pounds distributed in Wisconsin.

    Product
    Asenzya Hot & Spicy Cajun Style Seasoning, Item 121331. Net Wt 15 lbs. Distributed by: Asenzya 7616 South Sixth Street, Oak Creek, WI 53154.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0332-2024·2023-11-29

    Rhinolaryngoscope Models Recalled for Unvalidated Air Drying Process

    Aizu Olympus rhinolaryngoscopes (models ENF-T3, ENF-VT2, ENF-VT3) are recalled. The air-drying process for the instrument channel was not validated, and water remaining in some devices after repair poses contamination and infection risk.

    Product
    Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasopharyngeal and trachea). Model Numbers: ENF-T3, ENF-VT2, ENF-VT3.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0387-2024·2023-11-29

    Biomet Compress Device Short Anchor Plug recalled for metal burrs

    Biomet is recalling the Compress Device Short Anchor Plug due to metal burrs in transverse holes that may prevent proper insertion of drill or pins, potentially extending surgical time. No injuries have been reported.

    Product
    Compress Device Short Anchor Plug, 26 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178568
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0395-2024·2023-11-29

    Philips MRI Gradient Coil Recall Due to Fire and Smoke Risk

    Philips is recalling SmartPath to dStream 1.5T MRI systems due to a potential gradient coil failure that could produce smoke or fire. The recall affects 119 units distributed nationwide and internationally.

    Product
    SmartPath to dStream for 1.5T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0372-2024·2023-11-29

    Surgical Anchor Plug Devices Recalled for Potential Metal Burrs

    Biomet is recalling Compress Device Segmental Anchor Plugs due to metal burrs in transverse holes that may prevent surgical drill passage and extend surgery time.

    Product
    Compress Device Segmental Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178404
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0330-2024·2023-11-29

    Choleodochoscope Models Recalled Due to Unvalidated Air Drying Process

    Aizu Olympus choleodochoscopes with unvalidated air drying processes may retain water in the channel after repair, risking microbial contamination and patient infection. Affected models: CHF-BP30, CHF-CB30L, CHF-P60.

    Product
    Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0347-2024·2023-11-29

    Ureteralscopes recalled due to unvalidated drying process and contamination risk

    Aizu Olympus is recalling 1577 ureteralscope units due to an unvalidated channel air drying process that left some units with residual water after repair, creating a contamination and infection risk.

    Product
    Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct). Model Numbers: URF-P6, URF-P6R.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0333-2024·2023-11-29

    Gastroscope Devices Recalled for Inadequate Channel Drying Process

    Aizu Olympus recalls 680 gastroscope-EUS devices due to unvalidated channel drying. Water remaining in the channels poses contamination and infection risks.

    Product
    Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper digestive tract. Model Numbers: GF-UC140P-AL5, GF-UCT180, GF-UE160-AL5.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0465-2024·2023-11-29

    Jeni's Splendid Ice Cream Recalled for Aluminum and Steel Contamination

    Jeni's Splendid Ice Cream Buttercream Birthday Cake is recalled for potential aluminum and stainless steel pieces in the product. Consumers should stop consuming and return all affected packages.

    Product
    Jeni's Splendid Ice Cream: Buttercream Birthday Cake Ice Cream packaged in paperboard pint cups with heat seals and paper lids - 8 pints per case
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0113-2024·2023-11-29

    Buspirone Hydrochloride Tablets Recalled Due To Amlodipine Contamination Risk

    FDA recalls Buspirone Hydrochloride 10 mg tablets due to potential contamination with foreign Amlodipine Besylate tablets. The recall affects 1,344 blister cards distributed nationwide.

    Product
    BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0375-2024·2023-11-29

    Biomet Compress Device Anchor Plugs Recalled for Metal Burrs

    Biomet is recalling Compress Device Segmental Anchor Plugs due to metal burrs in transverse holes that may prevent proper device function during surgery. The defect could result in extended surgical time.

    Product
    Compress Device Segmental Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178410
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0337-2024·2023-11-29

    Hysterofiberscope Model HYF-XP Channel Drying Process Flaw Poses Infection Risk

    Aizu Olympus is recalling HYF-XP hysterofiberscopes because the channel air drying process was not validated. Some repaired units have wet channels that could harbor contamination and pose infection risk.

    Product
    Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0334-2024·2023-11-29

    Gastrointestinal videoscopes recalled due to unvalidated channel drying process

    Aizu Olympus is recalling 3,627 gastrointestinal videoscopes because the channel air drying process was not validated. A small percentage of devices returned after repair had wet channels, creating potential for contamination and risk of infection.

    Product
    Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q16
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0339-2024·2023-11-29

    Tracheal Videoscope Recall Due to Unvalidated Drying Process

    Aizu Olympus is recalling 61 tracheal videoscopes (Model LF-V) due to an unvalidated air drying process that left water in channels after repair. Water in the endoscope channels may become contaminated and pose an infection risk.

    Product
    Tracheal videoscope- For airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Number: LF-V.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0380-2024·2023-11-29

    Compress Device Short Anchor Plugs recalled due to metal burrs

    Biomet is recalling Compress Device Short Anchor Plugs (14 MM) due to potential metal burrs in transverse holes that may prevent proper insertion during surgery. The defect may extend surgical time.

    Product
    Compress Device Short Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178556
    Category
    Medical Device
    Distribution
    Distributed nationwide