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.

6251–6275 of 52958

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-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-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-0540-2025·2024-12-04
Philips dS Breast 7ch 3.0T MRI Coil Recalled for Patient Safety Hazard
Philips is recalling 5,231 dS Breast 7ch 3.0T breast MRI coils distributed nationwide due to a potential safety issue that may harm patients during scan preparation or scanning. The FDA classified this as Class II.
Product
dS Breast 7ch 3.0T
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-0161-2025·2024-12-04
H-E-B Griddle Waffles Recalled for Potential Listeria Contamination
Treehouse Foods is recalling H-E-B griddle waffles with blueberry and butter due to potential Listeria monocytogenes contamination. The recall affects approximately 9.9 million cases distributed nationwide.
Product
H-E-B 12/12.35oz GRDL WFL BLBRY-HEBUT UPC 041220008193
Category
Food
Distribution
Distributed nationwide
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-0168-2025·2024-12-04
Good & Gather and Breakfast Best Griddle Waffles Recalled for Listeria Risk
Treehouse Foods is recalling Good & Gather and Breakfast Best griddle waffles nationwide due to potential Listeria monocytogenes contamination. Affected batches have codes starting with 2C with best-by dates between October 1, 2024 and October 11, 2025.
Product
GOOD & GATHER 12/12.3oz GRDL WFL BLBRY-GDGTR UPC 085239157923 BREAKFAST BEST 12/12.3 OZ GRDL WFL BLBRY-BKBST UPC 4061464782273
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0208-2025·2024-12-04
SELECTION and COMPLIMENTS Griddle Waffles Recalled for Listeria Risk
Treehouse Foods is recalling SELECTION and COMPLIMENTS brand griddle waffles nationwide due to potential Listeria monocytogenes contamination. Consumers should not consume the affected products.
Product
SELECTION 1/1.68kg GRDL WFL ORIG-SLCTN UPC 059749904759 COMPLIMENTS 1/1.68kg GRDL WFL ORIG-CMPLM UPC 055742500530 SELECTION 12/280g GRDL WFL ORIG-SLCTN UPC 059749904704 COMPLIMENTS 12/280g GRDL WFL ORIG - CMPLM UPC 055742500547 SELECTION 12/560g GRDL WFL HSTYLE-SLCTN UPC 05974997
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0191-2025·2024-12-04
Griddle Waffles Recalled for Potential Listeria Contamination
Multiple brands of cinnamon griddle waffles are being recalled due to potential Listeria monocytogenes contamination. Approximately 9.9 million cases are affected.
Product
WESTERN FAMILY 12/280g GRDL WFL CIN - WSTCN UPC 062639310134 GREAT VALUE 12/280g GRDL WFL CIN - GRVLC UPC 681131811712 SELECTION 12/280g GRDL WFL CIN - SLCTN UPC 059749950640 COMPLIMENTS 12/280g GRDL WFL CIN - CMPLM UPC 055742500516 KROGER 12/12.3oz GRDL WFL CIN - KROGR UPC 01111
Category
Food
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0063-2025·2024-12-04
Drug recall: Absorbine Jr. Ultra Strength Pain Patch manufacturing deviations
Absorbine Jr. Ultra Strength Pain Patch is being recalled nationwide due to manufacturing process deviations. The voluntary recall affects approximately 4,968,000 patches.
Product
ABSORBINE jr ULTRA STRENGTH PAIN PATCH, Menthol 6.5%, 1 patch per box, Distributed By: Absorbine Jr. LLC, Chattanooga, TN 37402 UPC 8 89476 41318 3, UPC 8 89476 41336 7
Category
Drug
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-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-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
HighNHTSA·24E101000·2024-12-04
Prestone Recalls DOT 3 Brake Fluid Bottles Containing Power Steering Fluid
Prestone is recalling specific 1-gallon bottles of DOT 3 Brake Fluid that may contain power steering fluid. Using the wrong fluid can reduce braking performance and increase crash risk.
Product
SERVICE BRAKES, HYDRAULIC:FLUID recall
Category
Vehicle
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
HighFDA (Food)·F-0170-2025·2024-12-04
Multiple Store-Brand Griddle Waffles Recalled for Potential Listeria Contamination
Treehouse Foods is recalling approximately 9.9 million cases of frozen griddle waffles with blueberries distributed nationwide in the USA and Canada due to potential Listeria monocytogenes contamination.
Product
PRESIDENT'S CHOICE 12/320g GRDL WFL BLBRY GF-PCHOI UPC 060383038663 WILD HARVEST 12/11.3oz GRDL WFL BLBRY GF-WLDHR UPC 711535515173 WEGMANS 12/11.3oz GRDL WFL BLBRY GF-WEGMN UPC 077890519653 FULL CIRCLE 12/11.3oz GRDL WFL BLBRY GF-FULLC UPC 036800486980 FOODHOLD 12/11.3oz GRDL WF
Category
Food
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
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-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-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-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-0565-2025·2024-12-04
Baxter Peritoneal Dialysis Transfer Set: Female Connector Separation Risk
Baxter Healthcare recalls 8,394 MiniCap Extended Life PD Transfer Sets due to complaints of female connector separation from the transfer set body. This mechanical failure could interrupt dialysis treatment.
Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0502-2025·2024-12-04
Defibtech Defibrillation Pads Mislabeled, Creating Risk of Expired Pads in Use
Defibtech DDP-100 defibrillation pads distributed in Ireland had authorized labels replaced with unauthorized ones, making expired pads appear fresh. Dried hydrogel on expired pads may fail to deliver adequate energy for cardiac resuscitation.
Product
Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto (DDU-1:XX Series)- Indicated for use on victims of sudden cardiac arrest (SCA)
Category
Medical Device
Distribution
0 states