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.

8226–8250 of 26961

  • HighFDA (Devices)·Z-0564-2025·2024-12-04

    Baxter Peritoneal Dialysis Transfer Set Recalled for Connector Separation

    Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets due to an increase in complaints of female connector separation from the transfer set body. Peritoneal dialysis patients should contact their healthcare provider.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0542-2025·2024-12-04

    Mammotrak Interventional Coil 1.5T recalled for patient safety risk

    Philips is recalling 5,231 units of the Mammotrak Interventional Coil 1.5T nationwide due to a potential safety issue that may harm patients during MRI preparation or scanning.

    Product
    Mammotrak Interventional Coil 1.5T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0200-2025·2024-12-04

    Griddle Waffles Recalled for Potential Listeria Contamination

    Treehouse Foods is recalling approximately 9.9 million cases of Krusteaz griddle waffles and related products due to potential Listeria monocytogenes contamination. Products with batch codes starting with 2C and best-by dates through October 11, 2025 are included.

    Product
    KRUSTEAZ 1/2.5lb GRDL WFL BLGN 7-KRSTZ UPC 068615115168 KRUSTEAZ 1/11.25oz GRDL WFL BLGN-KRSTZ UPC BAKERS SOURCE 1/11.25oz GRDL WFL BLGN-BKRSC UPC 089356143562 GORDON FOOD SERVICE 3/2.5lb GRDL WFL BLGN 7-GDNFS UPC 093901310323
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0507-2025·2024-12-04

    V.A.C. Ulta Therapy Units Recalled Due to Occlusion Sensor Failures

    KCI USA is recalling 83,721 V.A.C. Ulta Negative Pressure Wound Therapy Units due to broken occlusion sensors that may prevent the device from initiating therapy. Affected units are distributed worldwide.

    Product
    V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0162-2025·2024-12-04

    H-E-B and Central Market Griddle Waffles Recalled for Listeria Risk

    H-E-B and Central Market brand griddle waffles with apple cinnamon are being recalled nationwide due to potential Listeria monocytogenes contamination affecting 9,907,389 cases.

    Product
    H-E-B 12/9oz GRDL WFL APL CIN ORG-HEBUT UPC 041220708376 CENTRAL MARKET 12/9oz GRDL WFL APL CIN ORG - CTMKT UPC 041220655748
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0535-2025·2024-12-04

    VITROS Chemistry CRP Diagnostic Slides May Underreport Elevated Results

    Ortho-Clinical Diagnostics is recalling 7,717 units of VITROS CRP diagnostic slides that may produce falsely low results for high C-reactive protein samples, risking missed diagnosis of infection or inflammation.

    Product
    VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma Model/Catalog Number: 1926740
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0209-2025·2024-12-04

    Duncan Hines Griddle Waffle Mix Recalled for Potential Listeria Contamination

    Treehouse Foods recalls Duncan Hines griddle waffle mix due to potential Listeria monocytogenes contamination. Affected products have batch codes starting with 2C and best-by dates from October 2024 to October 2025.

    Product
    DUNCAN HINES 1/3.36kg GRDL WFL ORIG - DUNHN UPC 091479060282
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0212-2025·2024-12-04

    Breakfast Best Griddle Waffles Recalled Due to Listeria Risk

    Treehouse Foods recalls Breakfast Best pumpkin griddle waffles due to potential Listeria monocytogenes contamination. Affected products were distributed nationwide with best-by dates from October 1, 2024, to October 11, 2025.

    Product
    BREAKFAST BEST 12/12.3oz GRDL WFL PMPKN-BKBST UPC 4099100336818
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0164-2025·2024-12-04

    Blueberry Waffles Recalled Due to Potential Listeria Contamination

    Multiple brands of frozen blueberry waffles manufactured by Treehouse Foods are recalled due to potential Listeria monocytogenes contamination. Approximately 9.9 million cases were distributed nationwide in the USA and Canada.

    Product
    WEGMANS 12/7.4oz GRDL WFL BLBRY ORG - WEGMN UPC 077890481417 NATURE'S PROMISE 12/7.4oz GRDL WFL BLBRY ORG - NTRPR UPC 688267058448 O ORGANICS 12/7.4oz GRDL WFL BLBRY ORG-OORGN UPC 079893801162 365 ORGANIC 12/7.4oz GRDL WFL BLBRY ORG - 365OR UPC 099482436971 SIMPLE TRUTH ORGANIC
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0198-2025·2024-12-04

    Nature's Path Organic Griddle Waffles Recalled for Potential Listeria Contamination

    Treehouse Foods is recalling Nature's Path Organic griddle waffles nationwide due to potential Listeria monocytogenes contamination affecting over 9.9 million cases.

    Product
    NATURES PATH ORGANIC 12/7.4oz GRDL WFL HSTYLE ORG GF-NPTHO UPC 058449590545 NATURES PATH ORGANIC 12/210g GRDL WFL HSTYLE ORG GF-NPOCN UPC 058449590521
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0566-2025·2024-12-04

    Baxter MiniCap Extended Life PD Transfer Set Connector Separation Complaints

    Baxter Healthcare is recalling the MiniCap Extended Life peritoneal dialysis transfer set due to complaints about female connector separation from the main body. The Class II recall affects 3,204 units distributed worldwide.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0519-2025·2024-12-04

    GE SIGNA Architect AIR MRI Systems Recalled for Elevated Acoustic Noise

    GE Medical Systems is recalling three SIGNA Architect AIR MRI systems due to gradient coils that can produce elevated acoustic noise during scanning. The units were distributed to the US and 12 countries worldwide.

    Product
    SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0515-2025·2024-12-04

    MEDLINE Epidural Procedure Kits: Connector May Prevent Catheter Insertion

    MEDLINE epidural trays used for labor anesthesia may have connectors that fail to fully open, preventing proper catheter insertion. The recall affects 2,592 units distributed across the US and internationally.

    Product
    MEDLINE procedure kits labeled as follows: 1) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699; 2) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0533-2025·2024-12-04

    Medline Surgical Implant Kits Recalled for Incorrect Suture Specifications

    Medline is recalling 360 surgical implant and thoracotomy kits because some suture packages contain incorrect needle types, sizes, or suture diameters and lengths. The affected kits were distributed to healthcare facilities in five states.

    Product
    (1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ904220F, 1 kit/case, non-sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0561-2025·2024-12-04

    Baxter Peritoneal Dialysis Transfer Set Connector Separation Recall

    Baxter Healthcare is recalling its MiniCap Extended Life PD Transfer Set due to reports of connector separation that could interrupt dialysis treatment. The recall affects 31,248 units distributed worldwide.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0539-2025·2024-12-04

    Philips Breast MRI System Recalled for Patient Safety Risk

    Philips is recalling 5,231 units of the dS Breast 7ch 1.5T breast MRI system due to a potential safety issue that could harm patients during preparation or scanning.

    Product
    dS Breast 7ch 1.5T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0150-2025·2024-12-04

    Treehouse Foods Plant-Based Waffles Recalled for Listeria Contamination Risk

    Treehouse Foods is recalling BREAKFAST BEST plant-based waffles nationwide due to potential Listeria monocytogenes contamination. Affected products have batch codes starting with 2C and best-by dates from October 2024 through October 2025.

    Product
    BREAKFAST BEST 12/8 OZ GRDL HSTYLE PLNT BSD WFL-BKBST UPC 4061459885750
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0545-2025·2024-12-04

    Philips SENSE Breast Coil Recall for Potential Patient Safety Hazard

    Philips is recalling 5,231 SENSE Breast Coils due to a potential patient safety hazard during scan preparation and performance. The FDA has not disclosed specific details about the nature of the risk.

    Product
    SENSE Breast Coil
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0174-2025·2024-12-04

    Griddle waffles recalled by Treehouse Foods for potential Listeria contamination

    Treehouse Foods is recalling Duncan Hines, Bakers Source, and Gordon Choice branded griddle waffles due to potential Listeria monocytogenes contamination. Products were distributed nationwide in the USA and Canada.

    Product
    DUNCAN HINES 1/3.41kg GRDL WFL BLGN 7IN-DUNHN UPC 091479060268 BAKERS SOURCE CANADA 1/3.41kg GRDL WFL BLGN 7IN - BKSCN GORDON CHOICE 1/3.41kg GRDL WFL BLGN ORIG-GDNCH
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0528-2025·2024-12-04

    Smiths Medical Tracheal Tube Exchange Guide Recalled for Inadequate Disinfection Risk

    Smiths Medical recalled its PORTEX Tracheal Tube Exchange Guide due to potential fluid ingress during reprocessing that may compromise disinfection standards and pose a contamination risk.

    Product
    smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0175-2025·2024-12-04

    Kodiak Cakes Buttermilk Griddle Waffles Recalled for Potential Listeria Contamination

    Treehouse Foods is recalling Kodiak Cakes griddle waffles (UPC 705599014802) due to potential Listeria monocytogenes contamination. The product was distributed nationwide in the United States and Canada.

    Product
    KODIAK CAKES 8/14.8oz GRDL WFL BLGN BTRMLK VAN-KDKCS UPC 705599014802
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0153-2025·2024-12-04

    Frozen griddle pancakes recalled for potential Listeria contamination

    Treehouse Foods is recalling frozen griddle pancakes from Wegmans, Yelloh, and Giant Eagle brands due to potential Listeria monocytogenes contamination. The products were distributed nationwide across the USA and Canada.

    Product
    WEGMANS 12/16.5oz GRDL PNCK BB-WEGMN UPC 077890481387 YELLOH 12/16.5oz GRDL PNCK BLBRY-YLLOH UPC 810038684680 GIANT EAGLE 12/16.5oz GRDL PNCK BLBRY-GT/EG UPC 030034011673
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0205-2025·2024-12-04

    Treehouse Foods Mini Griddle Waffles Recalled for Listeria Risk

    Multiple brands of frozen mini griddle waffles manufactured by Treehouse Foods are being recalled due to potential Listeria monocytogenes contamination affecting approximately 9.9 million cases nationwide.

    Product
    GIANT EAGLE 12/9oz GRDL WFL MINI HSTYLE - GT/EG UPC 030034088347 PICS BY PRICE CHOPPER 12/9oz GRDL WFL MINI HSTYLE - PRCHP UPC 041735010445 KRUSTEAZ 12/9oz GRDL WFL MINI HSTYLE-KRSTZ UPC 041820818963
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0194-2025·2024-12-04

    Griddle waffle and pancake mixes recalled due to Listeria monocytogenes

    Treehouse Foods is recalling multiple brands of griddle waffle and pancake mixes nationwide 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
    NO NAME 1/1.68kg GRDL WFL HSTYLE - NNAME UPC 060383987756 WESTERN FAMILY 12/280g GRDL WFL HSTYLE - WSTCN UPC 062639310165 GREAT VALUE 12/280g GRDL WFL HSTYLE - GRVLC UPC 681131712934 NO NAME 12/280g GRDL WFL HSTYLE - NNAME UPC 060383987664 YELLOH 12/19.75oz GRDL WFL HSTYLE-YLLOH
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0173-2025·2024-12-04

    Blueberry protein waffles recalled for potential Listeria contamination

    Multiple brands of frozen blueberry protein waffles are being recalled due to potential Listeria monocytogenes contamination. Products were distributed nationwide in the USA and Canada.

    Product
    H-E-B HIGHER HARVEST 12/10.72oz GRDL WFL BLBRY PRTN-HEBHH UPC 041220708093 BETTERGOODS 12/10.72oz GRDL WFL BLBRY PRTN-BTRGD UPC 194346252756 SIMPLE TRUTH 12/10.72oz GRDL WFL BLBRY PRTN - SMPTR UPC 011110108142 BREAKFAST BEST 12/13.4oz GRDL WFL BLBRY PRTN-BKBST UPC 4099100312997
    Category
    Food
    Distribution
    Distributed nationwide