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.

7951–7975 of 27089

  • SevereFDA (Food)·F-0313-2025·2025-01-01

    Raw Cucumbers Recalled for Potential Salmonella Contamination Risk

    SunFed Produce, Inc. is recalling raw cucumbers distributed nationally and internationally due to potential Salmonella contamination. The recall affects 71,070 cases.

    Product
    Raw cucumbers packaged in cardboard boxes or plastic boxes (RPC) with "SunFed", "Vegetables", or "Agrotato" labeling. 1 1/9 BU CAS Super Slicer Cucumber/10814780010749 1 1/9 BU CAS Select Slicer Cucumber/10814780010756 1 1/9 BU CAS Large Slicer Cucumber/10814780010763 1 1/9 BU
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0683-2025·2025-01-01

    Blood glucose ketone meter software bug causes erroneous result transmission

    Nova Biomedical's StatStrip glucose ketone hospital meter (Model 63910) has a software bug that may transmit erroneous results to healthcare systems. The issue affects 1,615 units distributed across the US and internationally.

    Product
    StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for near-patient testing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0681-2025·2025-01-01

    Glucose Hospital Meter Software Bug Transmits Inaccurate Results

    StatStrip Glucose Hospital Meter software bug may transmit erroneous glucose values to healthcare systems, potentially leading to incorrect patient treatment. 2,365 units affected nationwide and internationally.

    Product
    StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0708-2025·2025-01-01

    Cardiac Monitoring Software Failed to Properly Route ECG Events

    Braemar Manufacturing's Monitoring Service Application (versions 6.5-7.4) failed to properly route and review ECG events from July 2022-July 2024 due to a disabled analysis step. This affected about 130,000 units with 41,282 customers nationwide.

    Product
    Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0743-2025·2025-01-01

    3M Clarity Precision Orthodontic Attachments Recall for Improper Tooth Mating

    3M is recalling Clarity Precision Grip Attachments due to a design defect that may prevent proper fitting with digital treatment plans. The recall affects 171 orders distributed in the US, Canada, Australia, and New Zealand.

    Product
    Clarity Precision Grip Attachments, for use in orthodontic treatment. Part numbers/SKUs: 359-830 359-831 359-832 359-833 359-834 359-835 359-836 359-837
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0747-2025·2025-01-01

    Medical Device Recall: BD FACSLyric Flow Cytometer Power Supply Failure Risk

    BD is recalling power supply modules in FACSLyric flow cytometers that may fail to power on or remain powered. Failure could expose lab staff to fumes and cause patient specimen loss or delayed test results.

    Product
    FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cytometer, sheath tan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0316-2025·2025-01-01

    ZOE Daily 30+ Prebiotic Blend Recalled for Possible Foreign Objects

    ZOE brand Daily 30+ Prebiotic blend dietary supplements may contain small metal pieces or stones. Consumers should stop using affected batches and contact the manufacturer.

    Product
    ZOE brand Daily 30+ Prebiotic blend; Dietary Supplement; 500g resealable pouch
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0766-2025·2025-01-01

    EMPOWR 3D Knee Tibial Insert Package Mix-Up Causes Surgical Delays

    Encore Medical recalls EMPOWR 3D Knee Tibial Insert packages that may contain the wrong size implant (5R 16MM with 3R 14MM and vice versa), potentially delaying surgery. The recall affects 33 units nationwide.

    Product
    EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0725-2025·2025-01-01

    Surgical Patties and Strips with Endotoxin Contamination in Medline Convenience Kits

    Medline Industries is recalling surgical patties and strips in specific lots of KIT,SPINE LH Convenience Kits due to higher-than-expected endotoxin levels in raw materials. The contamination may result in out-of-specification endotoxin in finished sterile products.

    Product
    KIT,SPINE LH Convenience kit, SKU DYNJ906448A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0751-2025·2025-01-01

    Daytona Small Stature Locking Caps recalled for manufacturing defects

    SeaSpine Orthopedics is recalling 92 Daytona Small Stature CoCr Locking Caps due to manufacturing defects that prevent proper component mating. The devices were distributed in seven U.S. states.

    Product
    Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 Software Version: N/A Product Description: Locking Cap Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0731-2025·2025-01-01

    Abbott Vascular inflation device may leak during cardiovascular procedures

    Abbott Vascular is recalling 20/30 Priority Pack Accessory Kit inflation devices due to potential leaks that could cause air embolism during cardiovascular procedures.

    Product
    20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-0762-2025·2025-01-01

    MISHA Knee System Implants recalled due to fracture risk

    Moximed is recalling 115 MISHA Knee System Implants in multiple US states due to a supplier component defect that may cause the implant to fracture, potentially leading to pain, swelling, and stiffness.

    Product
    MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0315-2025·2025-01-01

    Diced cucumber products recalled for potential Salmonella contamination

    E-Z SPUDS is recalling approximately 23,340 pounds of diced cucumber products distributed in Illinois due to potential Salmonella contamination.

    Product
    Cucumber Diced Greek Cut (1/8"x1/8"x1"), 360# Drum with poly liner item C0376, 30# Box with poly liner item C0369. Cucumber Diced Regular Cut (1/8"x1/8"x1/4"), 300# Drum with poly liner item C0390, 30# Box with poly line C0383
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0742-2025·2025-01-01

    Galaxy System bronchoscope power supply defect may injure lung tissue

    Noah Medical's Galaxy System bronchoscope has defective power supply semiconductors that may fail during procedures, potentially causing pneumothorax or lung tissue injury when the scope is manually removed.

    Product
    Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0749-2025·2025-01-01

    BD FACSLyric Flow Cytometer Power Supply Failure Risk

    BD is recalling FACSLyric flow cytometer power supplies that may fail to power on or stay on, creating risks of fume inhalation and requiring patients to return for repeat biospecimen collection procedures.

    Product
    FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0156-2025·2025-01-01

    Duloxetine Delayed-Release Capsules Recalled Due to N-nitroso Impurity Contamination

    Amerisource Health Services is recalling certain lots of Duloxetine Delayed-Release Capsules due to N-nitroso impurity levels exceeding recommended limits. Consumers with the medication should contact their healthcare provider.

    Product
    Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0730-2025·2025-01-01

    Abbott 20/30 Indeflator devices recalled for potential leak risk

    Abbott Vascular is recalling 20/30 Indeflator devices used in cardiovascular procedures due to potential leaks that could cause air embolism.

    Product
    20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such as balloon dilatation catheters to create and monitor pressure in the balloon.
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-0758-2025·2025-01-01

    Medline Reprocessed Bruns Curette Surgical Instruments Recalled for Weak Sterile Seals

    Medline is recalling 21,440 reprocessed Bruns curettes due to weak sterile seals that may fail without user detection. This increases the risk of contamination and infection.

    Product
    ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0741-2025·2025-01-01

    Siemens epoc blood analyzer software assigns incorrect patient names

    Siemens epoc NXS blood analysis system has a software defect that can incorrectly assign patient names to blood test results, potentially causing misdiagnosis or mistreatment.

    Product
    epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0759-2025·2025-01-01

    Medline ST IUD Removal Hook Recalled Due to Weak Seals and Sterility Risk

    Medline Industries is recalling 21,440 units of the ST IUD Removal Hook due to weak seals that may compromise sterility. The defect is undetectable to users and could increase infection risk.

    Product
    ST IUD REMOVAL HOOK 10" (504090), Medline Item No. I68785
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0718-2025·2025-01-01

    Surgical patties and strips recalled due to endotoxin contamination

    Medline Industries is recalling FESS-MB PACK-LF Convenience kits containing surgical patties and strips due to higher-than-expected endotoxin levels in raw materials, resulting in out-of-specification finished products.

    Product
    FESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I. Convenience kits used for various procedures..
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0739-2025·2025-01-01

    Blood Analysis System Software Error Can Assign Wrong Patient Name

    Siemens epoc NXS Host blood analysis devices have a software malfunction that may assign the wrong patient name to blood test results, potentially leading to misdiagnosis or mistreatment.

    Product
    epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or ca
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0159-2025·2025-01-01

    Prescription chlorpromazine tablets recalled due to manufacturing quality defect

    Glenmark Pharmaceuticals is recalling chlorpromazine hydrochloride 10mg tablets nationwide due to manufacturing deviations that allowed excess N-nitroso impurity.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0755-2025·2025-01-01

    Medline Surgical Scissors Recalled for Sterility Seal Defect

    Medline O.R. scissors may have weak seals that compromise sterility, increasing risk of contamination and infection. Approximately 21,440 units from lot 2023052490 have been recalled nationwide.

    Product
    O.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000
    Category
    Medical Device
    Distribution
    Distributed nationwide