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.

8426–8450 of 27089

  • HighFDA (Food)·F-0201-2025·2024-12-04

    Treehouse Foods Griddle Waffles Recalled for Potential Listeria Monocytogenes

    Treehouse Foods is recalling griddle waffles sold under multiple retail brands due to potential Listeria monocytogenes contamination. Approximately 9.9 million cases were distributed nationwide.

    Product
    HANNAFORD 8/12.3oz GRDL WFL MLTGRN-HANNA UPC 041268196319 FOODHOLD 8/12.3oz GRDL WFL MLTGRN-FDHLD UPC 688267081958 H-E-B 12/12.3oz GRDL WFL MGRN - HEBUT UPC 041220908233 BEST CHOICE 12/12.3oz GRDL WFL MLTGRN-BSTCH UPC 070038622116 HARRIS TEETER 12/12.3oz GRDL WFL MGRN - HARTE UPC
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0214-2025·2024-12-04

    Breakfast Best Griddle Waffles Recalled for Potential Listeria Contamination

    Treehouse Foods is recalling approximately 9.9 million cases of Breakfast Best griddle waffles for potential Listeria monocytogenes contamination. Consumers should discard the product or return it to the retailer.

    Product
    BREAKFAST BEST 12/12.3oz GRDL WFL CHOC PEP MOCHA-BKBST UPC 04061463991591
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0203-2025·2024-12-04

    GOOD & GATHER griddle waffles recalled for potential Listeria contamination

    GOOD & GATHER and 365 ORGANIC brand griddle waffles are being recalled due to potential Listeria monocytogenes contamination. Affected products have batch codes starting with 2C and best-by dates from October 1, 2024 to October 11, 2025.

    Product
    GOOD & GATHER 12/9oz GRDL WFL MINI BLBRY ORG-GDGTR UPC 085239343012 365 ORGANIC 12/9oz GRDL WFL MINI BLBRY ORG - 365OR UPC 099482437008
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0571-2025·2024-12-04

    Essenz HLM Heart-Lung Machines May Fail Due to Software Defect

    The recalled Essenz HLM heart-lung machines (38 units) may experience GUI display failures and sensor deactivation. This can lead to hypoxia and hypoperfusion.

    Product
    Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0202-2025·2024-12-04

    Griddle waffles recalled due to potential Listeria contamination

    Treehouse Foods is recalling multiple store-brand griddle waffles due to potential Listeria monocytogenes contamination. Products were distributed nationwide across the USA and Canada.

    Product
    WEGMANS 12/7.4oz GRDL WFL MGRN ORG - WEGMN UPC 077890481431 GREENWISE 12/7.4oz GRDL WFL MGRN ORG - GRNWS UPC 041415209541 SE GROCERS NATURALLY BETTER 12/7.4oz GRDL WFL MGRN ORG - SEGNB UPC 607880200867 NATURE'S PROMISE 12/7.4oz GRDL WFL MLTGRN ORG-NTRPR UPC 688267188497 365 ORGAN
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0193-2025·2024-12-04

    Griddle Waffles with Flax Recalled Due to Listeria Contamination Risk

    Multiple brands of organic griddle waffles with flax are being recalled due to potential Listeria monocytogenes contamination. Affected products include Wegmans, H-E-B, Nature's Path Organic, and Central Market brands.

    Product
    WEGMANS 12/7.4oz GRDL WFL FLAX ORG - WEGMN UPC 077890481424 H-E-B 12/8.25oz GRDL WFL FLAX ORG-HEBUT UPC 041220708338 WEGMANS 12/8.25OZ 6CT GRDL WFL FLAX ORG-WEGMN UPC 077890577059 NATURES PATH ORGANIC 12/7.4oz GRDL WFL FLAX ORG - NPTHO UPC 058449590569 NATURES PATH ORGANIC 12/210
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0543-2025·2024-12-04

    Philips Mammotrak Diagnostic Coil 3.0T Recall Due to Patient Safety Risk

    Philips is recalling 5,231 Mammotrak Diagnostic Coil 3.0T units due to a potential safety issue that could harm patients during MRI scan preparation or scanning.

    Product
    Mammotrak Diagnostic Coil 3.0T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0534-2025·2024-12-04

    Medline Shoulder Repair Pack-LF Recalled for Incorrect Surgical Components

    Medline is recalling Shoulder Repair Pack-LF surgical kits (lot 24ABO552) due to incorrect needle type/size and suture diameter/length in some packages. No patient injuries have been reported.

    Product
    Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0152-2025·2024-12-04

    Treehouse Foods Recalls Frozen Waffles for Potential Listeria Contamination

    Treehouse Foods is recalling BREAKFAST BEST frozen griddle waffles nationwide due to potential Listeria monocytogenes contamination. Approximately 9.9 million cases are affected; consumers should not eat the product.

    Product
    BREAKFAST BEST 12/12.3oz MXD CS GRDL WFL PMPKN/CINN-BKBST UPC 4061463257208
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0521-2025·2024-12-04

    Surgical forceps and scissors handles recalled due to pin detachment

    MicroSurgical Technology is recalling MST Duet Reusable Handles for surgical forceps and scissors due to pin detachment risk. Six units distributed in the US; 18 internationally.

    Product
    Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads (Forceps and Scissors) Model/Catalog Number: DFH-1028 Software Version: N/A Product Description: A MST Single Use Forceps or Scissors System consists of a reusable han
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0559-2025·2024-12-04

    Baxter MiniCap Peritoneal Dialysis Transfer Set Connector Separation Recall

    Baxter is recalling MiniCap Extended Life PD Transfer Sets (Part Number 5C4482) due to reports of the female connector separating from the main body. Approximately 409,464 units are affected worldwide.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0513-2025·2024-12-04

    MEDLINE Epidural and Spinal Procedure Kits: Connector May Prevent Catheter Insertion

    MEDLINE is recalling 3,744 epidural and spinal procedure kits due to a connector defect that may prevent proper catheter insertion. Affected kits were distributed nationwide and internationally.

    Product
    MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF PAIN1069B; 2) CSE TRAY, REF PAIN1941; 3) TRAY CON EPID 20G NYL W/TUOHY, REF PAIN9023; 4) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN1281 5) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN9024
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0572-2025·2024-12-04

    TriALTIS Torque Limiter Ratchet Recalled for Excessive Torque Output

    Gauthier Biomedical is recalling the TriALTIS TORQUE LIMITER due to an out-of-specification component that may cause the device to produce higher torque output than intended. The recall affects 160 units.

    Product
    TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0206-2025·2024-12-04

    Organic Griddle Waffles Recalled for Potential Listeria Contamination

    Treehouse Foods is recalling organic griddle waffles sold under multiple brand names due to potential Listeria monocytogenes contamination. Affected products were distributed nationwide in the USA and Canada.

    Product
    GOOD & GATHER 12/9oz GRDL WFL MINI HSTYLE ORG-GDGTR UPC 085239343029 H-E-B 12/9oz GRDL WFL MINI HSTYLE ORG-HEBUT UPC 041220708413 365 ORGANIC 12/9oz GRDL WFL MINI HSTYLE ORG - 365OR UPC 099482436995 WEGMANS 12/9oz GRDL WFL MINI HSTYLE ORG - WEGMN UPC 077890481448
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0518-2025·2024-12-04

    GE SIGNA Architect MRI Systems Recalled for Elevated Acoustic Noise

    GE Medical Systems is recalling certain SIGNA Architect MRI systems because their gradient coils can produce elevated acoustic noise during scanning under specific conditions, potentially risking hearing damage.

    Product
    SIGNA Architect, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0510-2025·2024-12-04

    Medline Epidural Catheter Kits Recalled Due to Connector Position Defect

    Medline is recalling over 5,900 epidural catheter kits because the connectors may not open fully, preventing proper catheter insertion. The recall affects units distributed nationwide and internationally.

    Product
    MEDLINE procedure kits labeled as follows: 1) 20G EPI CATH SINGLE STERILE, REF EPICATH19 2) 20G EPI CATH SINGLE STERILE, REF EPICATH20
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0184-2025·2024-12-04

    Kodiak Cakes Griddle Waffles Recalled for Potential Listeria Contamination

    Treehouse Foods is recalling approximately 9.9 million cases of Kodiak Cakes griddle waffles nationwide due to potential Listeria monocytogenes contamination. Affected products have batch codes starting with 2C and Best By dates between October 1, 2024 and October 11, 2025.

    Product
    KODIAK CAKES 8/13.40oz GRDL WFL BTRMLK VAN-KDKCS UPC 705599012211
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0504-2025·2024-12-04

    Defibtech Adult Defibrillation Pads Recalled for Labeling Error Risk

    Defibtech is recalling 22,294 DDP-2001 Adult Defibrillation Pads distributed in Ireland. Some pads had unauthorized labels applied, which could allow expired pads to appear current, and dried hydrogel may reduce electrical delivery during use.

    Product
    Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, lifeline ECG, lifeline View (DDU-2XXX Series). -Indicated for use on victims of sudden cardiac arrest (SCA.)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0538-2025·2024-12-04

    Philips dS Breast MRI System Recalled for Patient Safety Hazard

    Philips dS Breast 16ch 3.0T MRI systems are being recalled due to a potential safety issue that could harm patients during medical scans. The FDA-mandated Class II recall affects 5,231 units distributed nationwide.

    Product
    dS Breast 16ch 3.0T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0169-2025·2024-12-04

    Kodiak Cakes Griddle Waffles Recalled Due to Listeria Risk

    Treehouse Foods recalls Kodiak Cakes 8/14.8oz Griddle Waffles due to potential Listeria monocytogenes contamination. Affected products carry batch codes starting with 2C and best-by dates from October 1, 2024 to October 11, 2025.

    Product
    KODIAK CAKES 8/14.8oz GRDL WFL BLGN BLBRY-KDKCS UPC 705599014826
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0185-2025·2024-12-04

    Griddle Waffles Recalled for Potential Listeria Contamination

    Multiple brands of griddle waffles are being recalled due to potential Listeria monocytogenes contamination. The recall affects products distributed nationwide in the USA and Canada.

    Product
    SELECTION 1/1.68kg GRDL WFL CHOC CHIP-SLCTN UPC 00059749977692 NO NAME 12/280g GRDL WFL CCH - NNAME UPC 060383987701 SELECTION 12/280g GRDL WFL CCH-SLCTN UPC 059749904711 COMPLIMENTS 12/280g GRDL WFL CHOC CHIP - CMPLM UPC 055742500509 HANNAFORD 8/12.3oz GRDL WFL CHOC CHIP-HANNA U
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0181-2025·2024-12-04

    Griddle Waffles and Buttermilk Products Recalled for Listeria Risk

    Multiple brands of griddle waffles and buttermilk products are recalled nationwide due to potential Listeria contamination. Affected products have batch codes starting with 2C and best-by dates from October 2024 to October 2025.

    Product
    WESTERN FAMILY 12/280g GRDL WFL BTRMLK - WSTCN UPC 062639310141 GREAT VALUE 12/280g GRDL WFL BTRMLK - GRVLC UPC 605388923455 NO NAME 12/280g GRDL WFL BTRMLK - NNAME UPC 060383987688 COMPLIMENTS 12/280g GRDL WFL BTRMLK-CMPLM UPC 055742500493 H-E-B 1/4.65lb GRDL WFL BTRMLK - HEBUT
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0570-2025·2024-12-04

    Arial Server Software Fails to Notify Users of Emergency Calls

    Securitas Healthcare's Arial Server Software versions 11.1.4 through 11.1.6 may fail to notify users when emergency calls are initiated through the Arial Nurse Call System, posing a patient safety risk.

    Product
    Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjunction with the Arial Mobile Application or Arial Care Giver Application
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0527-2025·2024-12-04

    Smiths Medical Tracheal Tube Introducer Recall Due to Inadequate Disinfection

    Smiths Medical is recalling reusable tracheal tube introducers due to potential fluid ingress during reprocessing and concerns about the adequacy of recommended disinfectants.

    Product
    smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0179-2025·2024-12-04

    Frozen Griddle and Belgian Waffle Products Recalled for Listeria Contamination Risk

    Treehouse Foods is recalling multiple frozen griddle and Belgian waffle brands nationwide due to potential Listeria monocytogenes contamination. No illnesses have been reported.

    Product
    DUNCAN HINES 1/3.12kg GRDL WFL BLGN ORIG 4IN - DUNHN UPC 091479060275 KRUSTEAZ 1/3.44lb GRDL WFL BLGN ORIG - KRSTZ UPC 686151903331 KRUSTEAZ 1/3.44lb GRDL WFL BLGN ORIG-KRSMX UPC 00686151805307 KRUSTEAZ 1/3.44lb GRDL WFL BLGN ORIG - KRSTZ UPC 686151904017 GORDON CHOICE 1/3.12kg G
    Category
    Food
    Distribution
    Distributed nationwide