The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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2676–2700 of 13380

  • HighFDA (Devices)·Z-2232-2025·2025-08-06

    Fresenius Kabi IV Administration Sets Recalled for Potential External Cassette Leaks

    Fresenius Kabi USA, LLC is recalling 19,225 units of its LVP Primary Administration Sets due to potential external cassette leaks. Affected lot codes have been distributed across multiple U.S. states.

    Product
    LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2221-2025·2025-08-06

    Volcano Visions IVUS Catheter Recall Due to Guide Wire Entanglement Risk

    Volcano Corp recalls approximately 233,817 IVUS catheters that may become entangled with guide wires during radial-to-peripheral procedures when used without appropriate guide sheaths. Entanglement may require surgical removal.

    Product
    Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with Instructions for use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2189-2025·2025-08-06

    Philips Allura X-ray Systems Software Issue Causes Temporary Imaging Loss

    Philips Allura R8.2.x fluoroscopy systems may experience temporary loss of X-ray imaging functionality due to a software issue. The recall affects 4,508 units distributed worldwide.

    Product
    Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Number: 722028. 4. Allura Xper FD20/10, Model Number: 722029. 5. Allura Xper FD10 OR Table,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2174-2025·2025-08-06

    Automated External Defibrillators recalled due to shock delivery malfunction

    HeartSine SAM 350P, 360P, and 450P automated external defibrillators may fail to deliver electrical shocks due to a component manufacturing defect. Approximately 190,516 units are affected worldwide.

    Product
    HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2219-2025·2025-08-06

    FUJIFILM Mammography Systems Recalled for Unapproved Software Function

    FUJIFILM is recalling 293 ASPRIRE Cristalle Mammography Systems worldwide due to an unapproved slabbing software function being enabled for use. Affected units were distributed in the United States, Canada, Chile, and Ecuador.

    Product
    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2212-2025·2025-08-06

    MRI System Gradient Coil May Produce Smoke or Fire

    Philips is recalling Intera 3.0T Quasar Dual MRI systems worldwide due to potential gradient coil failures that could generate smoke or fire.

    Product
    Intera 3.0T Quasar Dual Model Number (REF): 781150;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2198-2025·2025-08-06

    Precision Sampling Sets may contain residual carbon monoxide affecting measurements

    Precision Sampling Sets used with CoSense End-Tidal CO Monitors may contain residual carbon monoxide and volatile organic compounds due to insufficient aeration during manufacturing. This may cause inaccurate readings during clinical evaluations.

    Product
    Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2231-2025·2025-08-06

    3M Ranger Irrigation Fluid Warming Set Flow Rate Clarification Notice

    FDA issued a clarification notice for 3M Ranger Irrigation Fluid Warming Sets regarding flow rates related to inlet fluid temperature. Approximately 186,880 units distributed in the US and 48 other countries are affected.

    Product
    3M Ranger Irrigation Fluid Warming Set, REF 24750
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2150-2025·2025-08-06

    Molding Equipment Missing Required FDA Electronic Product Regulatory Label

    Apic Yamada America is recalling 6 units of WCM-330GL-i molding equipment that lacks required FDA electronic product labeling. The affected units do not bear labels required for compliance with FDA regulations.

    Product
    Molding Equipment. WCM series. Model WCM-330GL-i
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2193-2025·2025-08-06

    Sprinter Cart Infusion Pole recalled for labeling non-compliance

    Maquet is recalling 7,754 Sprinter Cart and Sprinter Cart XL Infusion Poles worldwide due to labeling that does not comply with international electrical safety standards (IEC 60601-1). No injuries or illnesses have been reported.

    Product
    Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2194-2025·2025-08-06

    LYFO-DISK Microbiological Quality Control Material May Fail to Function

    Microbiologics Inc is recalling LYFO-DISK quality control materials that may fail to properly recover the target microorganism, potentially compromising laboratory test validation procedures.

    Product
    LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2192-2025·2025-08-06

    Phasor Drill units recalled due to reverse battery orientation

    Phasor Drill neurosurgical units with reversed battery orientation are being recalled. The recall affects 1,064 units distributed across the United States and U.S. territories.

    Product
    Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-2143-2025·2025-07-30

    Ellik Evacuator sterilization instructions discrepancy between languages

    Olympus recalls Ellik Evacuators due to discrepancies in sterilization instructions between Japanese product inserts and manufacturer documentation. Inconsistent sterilization procedures could affect device safety.

    Product
    Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2130-2025·2025-07-30

    MR System Gradient Coils May Exceed Acoustic Noise Safety Limits

    GE HealthCare is recalling SIGNA Architect MR system gradient coils that can produce acoustic noise exceeding 99dB during scanning, potentially surpassing international safety limits even with required hearing protection.

    Product
    SIGNA Architect
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2152-2025·2025-07-30

    Estrone RIA diagnostic kits recalled for falsely elevated test results

    Beckman Coulter recalls Estrone RIA kits due to manufacturing defects in coated tubes causing falsely elevated estrone measurements. Affected lots were distributed in North Carolina and internationally.

    Product
    Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2163-2025·2025-07-30

    Johnson & Johnson recalls Acuvue Oasys Max contact lenses for manufacturing defects

    Johnson & Johnson Vision Care is recalling 114,165 Acuvue Oasys Max 1-Day Multifocal contact lenses due to bubbles and voids found during quality testing. The defects were identified during standard finished goods inspection.

    Product
    ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2166-2025·2025-07-30

    Biofinity Toric Multifocal Contact Lens Recalled for Potential Sterility Issues

    CooperVision is recalling Biofinity Toric Multifocal Contact Lenses with potentially compromised blister seals that may render the lenses unsterile. Approximately 827 units are affected worldwide.

    Product
    Biofinity Toric Multifocal Contact Lens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2132-2025·2025-07-30

    GE Discovery MR750w MRI System Gradient Coil Acoustic Noise Hazard

    GE HealthCare's Discovery MR750w 3.0T MRI systems can produce excessive acoustic noise from gradient coils during scanning, potentially exceeding safe hearing protection limits.

    Product
    Discovery MR750w 3.0T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2170-2025·2025-07-30

    Stryker StrykeFlow Suction Irrigator Recalled for Potential Liquid Leakage

    Stryker is recalling its StrykeFlow suction/irrigator device due to potential irrigation solution leakage into the handpiece and battery pack, which could cause device malfunction.

    Product
    Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2139-2025·2025-07-30

    Reusable Endoscope Seals Recalled Due to Sterilization Instructions Discrepancy

    Olympus reusable silicone seals for endoscopes are recalled because Japanese-language package instructions differ from the official sterilization guidance. Users following the incorrect instructions may not properly sterilize the device.

    Product
    Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen which allows instruments to be passed through the seal and minimize or prevent fl
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2171-2025·2025-07-30

    Stryker StrykeFlow Disposable Suction/Irrigator Malfunction Recall

    Stryker is recalling StrykeFlow disposable suction/irrigators because irrigation solution may leak into the handpiece and battery pack, causing potential device malfunction.

    Product
    Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2155-2025·2025-07-30

    Medline Convenience Kits with BD ChloraPrep Recalled for Open Seal

    Medline Convenience Kits containing BD ChloraPrep applicators are recalled for potential open seals that breach sterility and may cause patient infection. The 15,700 affected units were distributed to California, Florida, Pennsylvania, and Texas.

    Product
    Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: 1) BLOOD CULTURE KIT, REF DYNDH1462B; 2) BLOOD CULTURE KIT, REF DYNDH1622C; 3) BLOOD CULTR KT DIVRSN DEVICE, REF DYNDH1866.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2168-2025·2025-07-30

    Medtronic CareLink SmartSync Devices Abort Button Software Defect Limits Therapy Cancellation

    Medtronic CareLink SmartSync Patient Connectors have a software defect where the Abort button operates only in a limited time window during induction tests, potentially preventing users from canceling high voltage therapy delivery.

    Product
    Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2154-2025·2025-07-30

    Medline Convenience Kits with BD ChloraPrep Applicators Recalled Over Sterility Concerns

    Medline Convenience Kits containing BD ChloraPrep Clear applicators are being recalled due to potential open seals in packaging that could compromise sterility and lead to infection.

    Product
    Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF CDS860014P
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2165-2025·2025-07-30

    Biofinity XR Toric Contact Lenses Recalled for Sterility Concerns

    CooperVision is recalling Biofinity XR Toric contact lenses due to potential sterility issues caused by incomplete or leaking seals on lens blisters, which may introduce contamination.

    Product
    Biofinity XR Toric Contact Lens
    Category
    Medical Device
    Distribution
    Distributed nationwide