The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

9201–9225 of 22113

  • HighFDA (Food)·F-0207-2025·2024-12-04

    Kodiak Cakes Mini Griddle Waffles Recalled for Listeria Contamination Risk

    Treehouse Foods recalls Kodiak Cakes 8/9.88oz Mini Griddle Waffles sold nationwide due to potential Listeria monocytogenes contamination. Affected products have batch codes starting with 2C and Best By dates from October 1, 2024 through October 11, 2025.

    Product
    KODIAK CAKES 8/9.88oz GRDL WFL ORIG MINI-KDKCS UPC 705599017148
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0544-2025·2024-12-04

    Philips Mammotrak Interventional Coil MRI Device Recalled for Patient Safety

    Philips recalls 5,231 Mammotrak Interventional Coil 3.0T MRI devices nationwide due to a potential safety issue that could harm patients during scan preparation or imaging.

    Product
    Mammotrak Interventional Coil 3.0T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0547-2025·2024-12-04

    Philips ST SENSE Breast Coil Recalled for Potential Patient Safety Risk

    Philips is recalling 5,231 ST SENSE Breast Coils nationwide due to a potential safety issue that could harm patients during MRI scanning. Affected units are identified by specific serial numbers.

    Product
    ST SENSE Breast Coil
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0512-2025·2024-12-04

    MEDLINE Procedure Kits: Connectors May Prevent Intended Catheter Insertion

    MEDLINE procedure kits are being recalled because connectors may not allow proper catheter insertion if not fully opened. The recall affects 3006 units distributed in the US and internationally.

    Product
    MEDLINE procedure kits labeled as follows: 1) PERIPHERAL CONTINUOUS NERVE BL, REF PAIN1423A; 2) CONT. 20G EPI MRI COMPATIBLE, REF PAIN1470A; 3) EPIDURAL CATHETERIZATION KIT, REF PAIN1644
    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 (Devices)·Z-0548-2025·2024-12-04

    Philips ST SENSE Breast Imaging Coil Recalled for Patient Safety Risk

    Philips is recalling 5,231 units of the ST SENSE Breast Dx Coil nationwide due to a potential safety issue that may harm patients during breast imaging scans. No injuries have been reported.

    Product
    ST SENSE Breast Dx Coil
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0530-2025·2024-12-04

    AMS Artificial Urinary Sphincter Control Pump: Mislabeled Packaging Recall

    Boston Scientific recalled 16 units of AMS Artificial Urinary Sphincter Control Pumps due to mislabeled packaging where devices labeled as Pressure Regulating Balloons actually contained Control Pumps.

    Product
    AMS Artificial Urinary Sphincter Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0155-2025·2024-12-04

    Pancake and Griddle Mix Recalled for Potential Listeria Contamination

    Multiple brands of griddle pancake and buttermilk mix made by Treehouse Foods are being recalled nationwide due to potential Listeria monocytogenes contamination. Consumers should not consume the affected products.

    Product
    GIANT EAGLE 8/33oz GRDL PNCK BTRMLK - GT/EG UPC 030034071332 SCHNUCKS 8/33oz GRDL PNCK BTRMLK - SCHNK UPC 041318100020 SE GROCERS 8/33oz GRDL PNCK BTRMLK - SEGGR UPC 038259117170 BROOKSHIRE'S 8/33oz GRDL PNCK BTRMLK - BRKSH UPC 092825096740 SIGNATURE SELECT 8/33oz GRDL PNCK BTRML
    Category
    Food
    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-0531-2025·2024-12-04

    AMS Artificial Urinary Sphincter Balloon Mislabeled With Wrong Component

    Boston Scientific recalls 52 mislabeled AMS Artificial Urinary Sphincter balloons that may contain a Control Pump instead of the labeled Pressure Regulating Balloon component.

    Product
    AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V267000·2024-12-04

    Ford Bronco Sport Control Module Failure May Disable Drive Power

    Ford is recalling Bronco Sport and Maverick models due to control module defects that may fail to detect low battery charge, potentially disabling drive power and increasing crash risk. Dealers will provide free recalibration.

    Product
    FORD — 2022 FORD BRONCO SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • 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 (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 (Food)·F-0158-2025·2024-12-04

    KRUSTEAZ Griddle Pancake Mix Recalled Nationwide for Potential Listeria Contamination

    Treehouse Foods is recalling KRUSTEAZ Griddle Pancake Mix due to potential Listeria monocytogenes contamination. Approximately 9,907,389 cases with batch codes starting with '2C' and Best By dates from October 1, 2024, through October 11, 2025, are affected.

    Product
    KRUSTEAZ 12/15oz GRDL PNCK MINI BTRMLK-KTZCM UPC 686151200164
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0151-2025·2024-12-04

    Treehouse Foods Griddle Waffles Recalled for Potential Listeria Contamination

    Treehouse Foods is recalling BREAKFAST BEST griddle waffles nationwide due to potential Listeria monocytogenes contamination. Affected products have batch codes starting with 2C and Best By dates from October 1, 2024 through October 11, 2025.

    Product
    BREAKFAST BEST 12/13.4oz MXCS GRDL WFL PRTN 6BB 6BM-BKBST
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0503-2025·2024-12-04

    Pediatric defibrillation pads recalled due to labeling and hydrogel degradation

    Defibtech DDP-200P pediatric defibrillation pads distributed in Ireland are recalled due to unauthorized labeling that could make expired pads appear current, and hydrogel drying that may reduce electrical effectiveness.

    Product
    Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: Lifeline and Lifeline Auto (DDU-l XX Series)-Indicated for use on victims of sudden cardiac arrest (SCA.)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0196-2025·2024-12-04

    Simple Truth Griddle Waffles Recalled for Potential Listeria Contamination

    Treehouse Foods is recalling Simple Truth griddle waffles with batch codes starting with 2C due to potential Listeria monocytogenes contamination. Approximately 9.9 million cases were distributed nationwide in the USA and Canada.

    Product
    SIMPLE TRUTH 12/11.3oz GRDL WFL HSTYLE GF-SMPTR UPC 011110105493
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0517-2025·2024-12-04

    Discovery MR750w MRI Scanner Recalled for Elevated Acoustic Noise

    GE Medical Systems is recalling 8 Discovery MR750w 3.0T MRI scanners because their gradient coils can produce elevated acoustic noise during scanning under specific conditions.

    Product
    Discovery MR750w 3.0T, whole body magnetic resonance scanner
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • 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 (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 (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 (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 (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