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.

9176–9200 of 22113

  • 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 (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 (Devices)·Z-0511-2025·2024-12-04

    MEDLINE ultrasound procedure kit connectors recalled due to insertion malfunction

    Medline Industries is recalling procedure kits with connectors that may fail to open fully, preventing proper catheter insertion. The recall affects 3,396 units distributed in the U.S. and internationally.

    Product
    MEDLINE procedure kits labeled as follows: 1) ECHOSTIM BLOCK SET, REF DYNJRA9043S; 2) ULTRASOUND BLOCK PREP TRAY, REF PAIN1622A
    Category
    Medical Device
    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-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 (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-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-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-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 (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 (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
  • HighNHTSA·23V288000·2024-12-04

    2023 Forest River Salem and Wildwood Travel Trailers: Brake Wiring Defect

    Forest River is recalling certain 2023 Salem and Wildwood travel trailers because the brakes may be incorrectly wired, resulting in potential loss of brake function and increased crash risk.

    Product
    FOREST RIVER — 2023 FOREST RIVER SALEM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0532-2025·2024-12-04

    Medline Surgical Kits Recalled for Incorrect Needle and Suture Specifications

    Medline Industries is recalling 408 surgical kits from Alabama, Georgia, Massachusetts, New Jersey, and Pennsylvania. Some suture packages within the kits contain incorrect needle types and sizes, and incorrect suture diameters and lengths.

    Product
    (1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV, REF DYNJ903016G, packaged 1 kit/case, non-sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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-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-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 (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-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 (Devices)·Z-0529-2025·2024-12-04

    Tracheal Tube Exchange Guide Recalled for Inadequate Disinfection Risk

    Smiths Medical is recalling PORTEX Tracheal Tube Exchange Guides due to potential fluid ingress during reprocessing and inadequate disinfection per applicable standards.

    Product
    smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76
    Category
    Medical Device
    Distribution
    0 states
  • 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
  • HighFDA (Devices)·Z-0546-2025·2024-12-04

    SENSE Breast Coil 3.0T recalled due to potential patient safety hazard

    Philips is recalling approximately 5,231 SENSE Breast Coil 3.0T units due to a potential safety hazard that could harm patients during MRI scanning procedures.

    Product
    SENSE Breast Coil 3.0T 7ch
    Category
    Medical Device
    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-0187-2025·2024-12-04

    BetterGoods Griddle Waffles Recalled Due to Potential Listeria Contamination

    Treehouse Foods is recalling BetterGoods griddle waffles with chocolate protein because they may be contaminated with Listeria monocytogenes. The recall affects products distributed nationwide in the United States and Canada.

    Product
    BETTERGOODS 12/10.72oz GRDL WFL CCH PRTN-BTRGD UPC 194346252763
    Category
    Food
    Distribution
    Distributed nationwide