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.

6301–6325 of 52958

  • 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-0553-2025·2024-12-04

    Shimadzu Autosampler Water Intrusion May Cause Electrical Short Circuit

    Shimadzu laboratory autosamplers are being recalled due to water intrusion from a dehumidifier that can cause electrical short circuits. Affected units are distributed worldwide, including across the United States.

    Product
    Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL
    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 (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-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-0569-2025·2024-12-04

    Baxter MiniCap Extended Life PD Transfer Set—Connector Separation Recall

    Baxter Healthcare is recalling the MiniCap Extended Life PD Transfer Set due to reports of the female connector separating from the transfer set body. The defect may compromise dialysis treatment safety.

    Product
    Baxter MiniCap Extended Life PD Transfer Set (short) with Titanium Spike, Part Number T5C4326K; use in Peritoneal Dialysis
    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-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-0177-2025·2024-12-04

    Griddle waffles recalled for potential Listeria contamination

    Treehouse Foods recalls KRUSTEAZ and GOOD & GATHER griddle waffles 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
    KRUSTEAZ 1/3.44lb GRDL WFL BLGN DBL CHOC-KRSTZ UPC 00041820818734 KRUSTEAZ 12/13.75oz GRDL WFL BLGN DBL CHOC-KRSTZ UPC 041820818697 GOOD & GATHER 12/13.75oz GRDL WFL BLGN DBL CHOC-GDGTR UPC 085239157930
    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 (Food)·F-0154-2025·2024-12-04

    Breakfast Best Griddle Pancakes Recalled for Potential Listeria Contamination

    Treehouse Foods is recalling Breakfast Best griddle pancakes 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
    BREAKFAST BEST 8/33oz GRDL PNCK BDAY-BKBST UPC 4061459959116
    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 (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-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
  • 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-0157-2025·2024-12-04

    Signature Select Griddle Pancakes Recalled for Potential Listeria Contamination

    Treehouse Foods is recalling Signature Select Griddle Pancake Mini packages due to potential Listeria monocytogenes contamination. The recall involves 9,907,389 cases distributed across the United States and Canada.

    Product
    SIGNATURE SELECT 12/14.1oz GRDL PNCK MINI-SIGSL UPC 021130095889
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0537-2025·2024-12-04

    Philips dS Breast 16ch 1.5T MRI Recalled for Patient Safety Risk

    Philips North America is recalling approximately 5,231 dS Breast 16ch 1.5T MRI systems nationwide due to a potential safety issue that could harm patients during scan preparation or procedures.

    Product
    dS Breast 16ch 1.5T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0180-2025·2024-12-04

    Krusteaz Griddle Waffles Recalled for Potential Listeria Monocytogenes

    Treehouse Foods is recalling Krusteaz brand griddle waffles due to potential Listeria monocytogenes contamination. Products were distributed nationwide in the USA and Canada.

    Product
    KRUSTEAZ 1/3.44lb GRDL WFL BLGN PMPKNN - KRSTZ UPC 686151805277 KRUSTEAZ 12/13.75oz GRDL WFL BLGN PMPKN-KRSTZ UPC 686151805345
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0213-2025·2024-12-04

    SELECTION Griddle Waffles Recalled Due to Potential Listeria Contamination

    Treehouse Foods is recalling SELECTION brand griddle waffles nationwide due to potential Listeria monocytogenes contamination. The recall affects about 9.9 million cases distributed in the USA and Canada.

    Product
    SELECTION 12/320g GRDL WFL WW-SLCTN UPC 059749977678
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0156-2025·2024-12-04

    Treehouse Foods Griddle Pancakes Recalled for Potential Listeria Contamination

    SE Grocers and Pics by Price Chopper brand griddle pancakes are being recalled by Treehouse Foods due to potential Listeria monocytogenes contamination. Affected products were distributed nationwide in the USA and Canada.

    Product
    SE GROCERS 12/16.5oz GRDL PNCK HSTYLE-SEGGR UPC 038259117194 PICS BY PRICE CHOPPER 12/16.5oz GRDL PNCK HSTYLE-PRCHP UPC 041735157386
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0522-2025·2024-12-04

    HPV-16 Diagnostic Probe Recalled for Suboptimal DNA Hybridization

    Kreatech PapV-16 HPV-16 diagnostic probes are recalled for suboptimal DNA hybridization due to oversized DNA fragments. This may cause false positives or false negatives if proper laboratory controls are not used.

    Product
    Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0199-2025·2024-12-04

    Multiple Brands of Griddle Waffles Recalled for Potential Listeria Contamination

    Treehouse Foods is recalling griddle waffles sold under multiple store brands due to potential Listeria monocytogenes contamination. The recall affects products distributed nationwide in the USA and Canada.

    Product
    PICS BY PRICE CHOPPER 6/29.6oz GRDL WFL HSTYLE RF - PRCHP UPC 041735064912 ALWAYS SAVE 12/9.9oz GRDL WFL HSTYLE RF - ASAVE UPC 070038608752 ESSENTIALS 12/9.9oz GRDL WFL HSTYLE RF - ESSEN UPC 607880101874 KROGER 1/4.63lb GRDL WFL HSTYLE RF - KROGR UPC 011110880109 FOOD LION 8/12.3
    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 (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 (Devices)·Z-0505-2025·2024-12-04

    Defibtech Pediatric Defibrillation Pads: Mislabeling and Hydrogel Drying Risk

    Defibtech DDP-2002 pediatric defibrillation pads distributed in Ireland may be mislabeled with unauthorized labels, potentially making expired pads appear current. Hydrogel drying could impair electrical connection and reduce energy delivery during treatment.

    Product
    Defibtech DDP-2002: Pediatric 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