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.

9326–9350 of 88183

  • HighFDA (Devices)·Z-1002-2025·2025-01-29

    Olympus Thunderbeat surgical instrument probe tips may damage or break

    Olympus is recalling Thunderbeat surgical hand instruments due to damaged or breaking probe tips that may occur during use and affect surgical procedure safety.

    Product
    Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5424110¿ Software Version: N/A Product Description: Thunderbeat instrument is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0974-2025·2025-01-29

    BD Pyxis MedStation 4000 Medication Cabinet Drawer and Door Failures

    CareFusion 303 is recalling 5,056 BD Pyxis MedStation 4000 AUX units worldwide due to drawer and door failures that may delay medication access. Failures include door latch failure, cable ribbon damage, and magnet falling out.

    Product
    BD Pyxis MedStation 4000 AUX, REF 306
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0995-2025·2025-01-29

    Olympus Thunderbeat Surgical Hand Instruments Recalled for Damaged Probe Tips

    Olympus has recalled Thunderbeat surgical hand instruments because the probe tips can become damaged or broken, including pad damage and detachment. The recall affects 36,712 units distributed internationally outside the United States.

    Product
    Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5424030 Software Version: N/A Product Description: Thunderbeat instrument is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0966-2025·2025-01-29

    Otological Ventilation Tubes Recalled for Lack of FDA Premarket Clearance

    Adept Medical Ltd is recalling Otological Ventilation Tubes (T-Tube 9mm, Silicone) distributed without FDA 510(k) premarket notification clearance. Approximately 6,280 units were distributed in the US and internationally.

    Product
    Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0421-2025·2025-01-29

    The Granola Bar OG Bar Recalled for Undeclared Milk and Soy

    The Granola Bar's OG Bar granola bars are being recalled due to undeclared milk and soy allergens. People with allergies to these ingredients should not consume this product.

    Product
    The Granola Bar brand The OG Bar; 4 oz; Ingredients: Oats, brown sugar, honey, almonds, butter, olive oil, cashews, coconut flakes, chia seeds, vanilla extract, kosher salt; Contains: Tree nuts. Baked in a facility that also processes wheat, eggs, dairy, soy and nuts.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1011-2025·2025-01-29

    Baxter Continu-Flo Solution Set with Duo-Vent Spike recalled for inverted clamps

    Baxter is recalling specific lots of Continu-Flo Solution Sets due to potentially inverted side clamps that render the tubing unusable. Distribution included eight US states.

    Product
    Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0976-2025·2025-01-29

    BD Pyxis Med 4000 Auxiliary Drawer and Door Failures Delay Medication Access

    CareFusion 303, Inc. is recalling 5 units of the BD Pyxis Med 4000 Auxiliary medication dispensing system due to drawer and door failures that may delay access to medications. Three failure modes identified: door latch failure, cable ribbon damage, and magnet falling out.

    Product
    BD Pyxis Med 4000 Auxiliary (AUX), REF 314
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0422-2025·2025-01-29

    Frozen Buttered Vegetables Recall Due to Undeclared Milk Allergen

    Lidl's frozen buttered vegetables are recalled because the product labels do not disclose milk as an ingredient. Approximately 35,320 units distributed across nine states are affected.

    Product
    Buttered Vegetables KEEP FROZEN NET WT 10.5 OZ (300g) INGREDIENTS: CARROTS, PEAS, CALIFLOWER, CORN, BUTTER, SUGAR, SALT, CORN STARCH, PARSLEY MAY CONTAIN WHEAT. DISTRIBUTED BY LIDL USA, LLC. 3500 S. CLARK STREET, ARLINGTON, VA 22202 UPC 4 056489 122876
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-0998-2025·2025-01-29

    Olympus Thunderbeat Surgical Instrument Recalled for Damaged or Breaking Probe Tips

    Olympus is recalling approximately 9,200 units of Thunderbeat surgical hand instruments distributed worldwide because probe tips can become damaged, break, or pads can detach during use.

    Product
    Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N5423330 Software Version: N/A Product Description: Thunderbeat instrument is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1007-2025·2025-01-29

    VITROS 3600 Diagnostic System May Fail to Alert Users to Expired Reagents

    The VITROS 3600 Immunodiagnostic System may not properly alert users when Signal Reagent Packs expire, risking use of expired products and potentially inaccurate test results. Affected systems worldwide should be checked for this software issue.

    Product
    Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished), 6904000 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0987-2025·2025-01-29

    Heart Failure Monitoring System Unable to Transmit Patient Readings After Cloud Migration

    The Merlin.net Heart Failure monitoring application cannot transmit patient readings after a data migration to a cloud environment. Some systems (25 total) distributed across 13 U.S. states are affected.

    Product
    Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Hospital System model CM3100) The CardioMEMS" HF System provides pulmonary artery (PA) hemodynamic data used for monitoring and management of heart failure…
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1004-2025·2025-01-29

    BD PCR Cartridges for MAX System signal drift in select lots

    Specific lots of BD PCR Cartridges used with the MAX System may experience signal drift, potentially affecting diagnostic accuracy. BD has initiated a recall of 516,435 affected units worldwide.

    Product
    BD PCR Cartridges used with MAX System. Model Number: 437519
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0985-2025·2025-01-29

    Medtronic Recalls EOPA Arterial Cannula Models for Labeling Errors

    Medtronic Perfusion Systems is recalling EOPA Arterial Cannula models 77418 and 77422 due to incorrect labeling on seven manufacturing lots. Approximately 930 units were distributed worldwide.

    Product
    EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1006-2025·2025-01-29

    Diagnostic analyzer software may fail to alert users to expired reagents

    VITROS XT 7600 Integrated System software may not warn users when Signal Reagent Packs expire, risking inaccurate or missing test results.

    Product
    Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0994-2025·2025-01-29

    Olympus Thunderbeat Hand Instrument Probe Tips May Break or Detach

    Olympus is recalling the Thunderbeat surgical hand instrument because the probe tips are being damaged or breaking. The recall affects 34,325 units distributed in the US and internationally.

    Product
    Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat Front-Actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: R5000688 Software Version: N/A Product Description: Thunderbeat instrument is a sterile…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1010-2025·2025-01-29

    Baxter Clearlink system solution sets recalled for clamp defect

    Baxter Healthcare is recalling specific lots of Clearlink System Solution Sets with inverted clamps that render the tubing unusable. The affected units are distributed nationwide in eight U.S. states.

    Product
    Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1018-2025·2025-01-29

    Randox Lipoprotein (a) Diagnostic Assay Lacks FDA Clearance, Recalled

    Randox Laboratories is recalling 33 Randox Lipoprotein (a) diagnostic kits nationwide. The assay's claims for use on Roche Cobas c501 analyzers lack required FDA clearance or approval.

    Product
    Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0988-2025·2025-01-29

    CardioMEMS HF Pressure Measurement System Recalled for Inaccurate Readings

    St. Jude Medical is recalling the CardioMEMS HF Pressure Measurement System due to a cloud data migration that caused the system to revert to an outdated configuration, resulting in inaccurate pulmonary artery pressure readings.

    Product
    CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics System (PES) REF CM1100 Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Which interfaces with CardioMEMSTM HF System Patient Electronics System (PES) and CardioMEMSTM HF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0990-2025·2025-01-29

    Microvention Headway Microcatheter Recall Due to Incomplete Packaging Seal

    Microvention is recalling Lot #0000629846 of the Headway 17 Advanced Straight Microcatheter due to incomplete seals in inner packaging that could compromise sterility. The affected lot was distributed outside the U.S.

    Product
    Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0982-2025·2025-01-29

    Stryker 3.0MM Neuro Precision Head Recalled for Package Labeling Mismatch

    Stryker is recalling the 3.0MM Precision Neuro Match Head due to a packaging discrepancy where the device may not match the product label. Approximately 1,489 units distributed worldwide are affected, including lot numbers 22179047, 22179027, and 22160017.

    Product
    stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0206-2025·2025-01-29

    First Aid Beauty Ultra Repair Cream Recalled for CGMP Deviations

    First Aid Beauty is recalling Ultra Repair Cream due to CGMP (Current Good Manufacturing Practice) deviations. Product intended for quarantine was inadvertently distributed nationwide.

    Product
    First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla, Net Wt. 396.8 g (14 OZ), DISTR. BY: First Aid Beauty LTD, Newton, MA, 02458, UPC 8 15517 02955 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0981-2025·2025-01-29

    Stryker neurosurgical device labeling mismatch: wrong instruments shipped

    Stryker is recalling 3.0MM Neuro Match Head devices (REF 5820-107-430) where the actual device may not match the product label, potentially causing surgeons to use wrong instruments during neurosurgery.

    Product
    stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0989-2025·2025-01-29

    CardioMEMS Heart Failure Monitoring System Cloud Migration Causes Inaccurate Pressure Readings

    St. Jude Medical recalled 431 CardioMEMS HF pressure measurement systems after a cloud data migration reverted systems to outdated configuration, causing inaccurate pulmonary artery pressure readings.

    Product
    CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Which interfaces with CardioMEMSTM HF System Patient Electronics System (PES) and CardioMEMSTM HF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1014-2025·2025-01-29

    Dressing Change Kits Recalled for Potential Package Sterility Compromise

    Trinity Sterile is recalling Wolf-Pak Dressing Change Kits due to a potential hole in the package that could compromise the sterility of the medical kit. Lot #600022 (3,960 units) distributed nationwide.

    Product
    Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3080LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 132 cases affected.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1015-2025·2025-01-29

    Dressing Change Kit Recalled Due to Package Integrity Concern

    Trinity Sterile is recalling Wolf-Pak Premium Dressing Change Kits due to potential holes in packaging that could compromise sterility. The recall affects 5,940 units distributed in Maryland, Pennsylvania, Tennessee, and Texas.

    Product
    Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC5090LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600088, 198 cases affected. Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide