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.

9126–9150 of 22113

HighFDA (Food)·F-0163-2025·2024-12-04
Treehouse Foods Frozen Griddle and Blueberry Waffles Recalled for Listeria Risk
Treehouse Foods is recalling multiple store-brand frozen waffles nationwide for potential Listeria monocytogenes contamination. The recall affects products with batch codes starting with 2C and best-by dates from October 1, 2024 to October 11, 2025.
Product
PICS BY PRICE CHOPPER 6/29.6oz GRDL WFL BB - PRCHP UPC 041735089656 NO NAME 1/1.68kg GRDL WFL BB - NNAME UPC 060383987732 NO NAME 12/280g GRDL WFL BB - NNAME UPC 060383987671 WESTERN FAMILY 12/280g GRDL WFL BLBRY - WSTCN UPC 062639335861 GREAT VALUE 12/280g GRDL WFL BB - GRVLC UP
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0186-2025·2024-12-04
Treehouse Foods recalls Nature's Path organic griddle waffles for Listeria contamination risk
Treehouse Foods is recalling Nature's Path Organic griddle waffles due to potential Listeria monocytogenes contamination. The affected products were distributed nationwide in the United States and Canada.
Product
NATURES PATH ORGANIC 12/7.4oz GRDL WFL CHOC CHIP ORG GF-NPTHO UPC 058449167013 NATURES PATH ORGANIC 12/210g GRDL WFL CHOC CHIP ORG GF-NPOCN UPC 058449167006
Category
Food
Distribution
Distributed nationwide
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 (Devices)·Z-0514-2025·2024-12-04
MEDLINE Neuraxial Kit Connectors May Prevent Catheter Insertion
MEDLINE has recalled 360 units of its Neuraxial Kit (Lot 23KLA330) because connectors may not fully open, potentially preventing catheters from being inserted as intended. Healthcare facilities should discontinue use and contact MEDLINE.
Product
MEDLINE procedure kits labeled as follows: 1) NEURAXIAL KIT, REF PAIN1876A
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-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 (Food)·F-0183-2025·2024-12-04
Multiple Brands Griddle Waffles Recalled for Listeria Contamination Risk
Multiple brands of griddle waffles manufactured by Treehouse Foods are being recalled nationwide due to potential Listeria monocytogenes contamination. Affected products include GOOD & GATHER, H-E-B HIGHER HARVEST, BETTERGOODS, BREAKFAST BEST, and SIMPLE TRUTH brands.
Product
GOOD & GATHER 12/10.72oz GRDL WFL BTRMLK VAN PRTN-GDGTR UPC 085239157961 H-E-B HIGHER HARVEST 12/10.72oz ORIG PRTN-HEBHH UPC 041220013685 BETTERGOODS 12/13.4oz GRDL WFL BTRMLK VAN PRTN-BTRGD UPC 194346252749 BREAKFAST BEST 12/13.4oz GRDL WFL BTRMLK VAN PRTN-BKBST UPC 409910031300
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-0563-2025·2024-12-04
Baxter Peritoneal Dialysis Transfer Set Connector Separation Recall
Baxter is recalling 83,448 units of MiniCap Extended Life PD Transfer Sets due to reports of female connector separation from the device body.
Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-0211-2025·2024-12-04
Nature's Path Organic Griddle Waffles Recalled for Listeria Contamination Risk
Nature's Path Organic 12-pack griddle waffles with batch codes starting 2C and best-by dates between October 2024 and October 2025 are recalled due to potential Listeria monocytogenes contamination. No illnesses reported.
Product
NATURES PATH ORGANIC 12/210g GRDL WFL PMPKN ORG GF-NPTHO UPC 058449590774
Category
Food
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 (Food)·F-0147-2025·2024-12-04
Hannaford Seafood Salad Recalled for Undeclared Soy Protein Allergen
Hannaford brand seafood salad is recalled because it contains undeclared hydrolyzed soy protein. Consumers with soy allergies should be aware of this risk.
Product
Hannaford brand seafood salad; Net Wt. 12 oz. (340g); INGREDIENTS: SEAFOOD BLEND (FISH PROTEIN [ALASKA POLLOCK AND/OR PACIFIC WHITING], WATER, WHEAT STARCH, SUGAR, SORBITOL, MODIFIED POTATO STARCH, CONTAINS 2% OR LESS OF: NATURAL AND ARTIFICIAL CRAB FLAVORS [SWIMMING CRAB, SNOW C
Category
Food
Distribution
0 states
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 (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-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 (Food)·F-0204-2025·2024-12-04
Kodiak Cakes Griddle Waffles Recalled for Potential Listeria Contamination
Treehouse Foods is recalling Kodiak Cakes griddle waffles nationwide due to potential Listeria monocytogenes contamination in batch codes starting with 2C.
Product
KODIAK CAKES 8/9.88oz GRDL WFL CINN MINI-KDKCS UPC 705599017162
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0166-2025·2024-12-04
Nature's Path Organic Griddle Waffles Recalled for Potential Listeria Contamination
Treehouse Foods is recalling Nature's Path Organic Griddle Waffles (9,907,389 cases) for 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
NATURES PATH ORGANIC 12/7.4oz GRDL WFL BCKWHE BRY ORG GF-NPTHO UPC 058449590583 NATURES PATH ORGANIC 12/210g GRDL WFL BCKWHE BRY ORG GF-NPOCN UPC 058449590576
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0560-2025·2024-12-04
Baxter MiniCap Peritoneal Dialysis Transfer Set Connector Separation Recall
Baxter is recalling 22,392 units of MiniCap Extended Life PD Transfer Sets (Part Number 5C4482EJ) due to reports of female connector separation. Affected units were distributed worldwide.
Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0538-2025·2024-12-04
Philips dS Breast MRI System Recalled for Patient Safety Hazard
Philips dS Breast 16ch 3.0T MRI systems are being recalled due to a potential safety issue that could harm patients during medical scans. The FDA-mandated Class II recall affects 5,231 units distributed nationwide.
Product
dS Breast 16ch 3.0T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0580-2025·2024-12-04
MICRO-X Rover Mobile X-ray System environmental operating requirements
Micro-X Ltd. is recalling 6 units of the MICRO-X Rover Mobile X-ray System due to environmental operating risks. The system requires strict temperature, humidity, and altitude controls to prevent capacitor malfunction, overheating, and unintended start-up.
Product
MICRO-X Rover Mobile X-ray System, # MXU-RV35
Category
Medical Device
Distribution
4 states
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-0149-2025·2024-12-04
Pero Family Farms Squash Sliced Zucchini recalled for potential Listeria contamination
Pero Family Farms Squash Sliced Zucchini & Yellow Squash is being recalled due to potential Listeria monocytogenes contamination. Consumers should not consume the product and should discard it or return it to the point of purchase.
Product
Pero Family Farms Squash Sliced Zucchinni & Yellow Squash, Net Wt. 11oz (311g) Plastic Tray, 4 trays per carton, Microwavable Tray, Keep Refrigerated. UPC 874896009764
Category
Food
Distribution
4 states
HighFDA (Food)·F-0197-2025·2024-12-04
Organic Griddle Waffles Recalled for Potential Listeria Contamination
Treehouse Foods is recalling approximately 9.9 million cases of organic griddle waffles from multiple brands due to potential Listeria monocytogenes contamination. Consumers should not consume the affected products.
Product
WEGMANS 12/7.4oz GRDL WFL HSTYLE ORG - WEGMN UPC 077890481400 NATURE'S BASKET 12/7.41oz GRDL WFL HSTYLE ORG-NTBKU UPC 030034944483 NATURE'S PROMISE 12/7.4oz GRDL WFL HSTYLE ORG - NTRPR UPC 688267058431 O ORGANICS 12/7.4oz GRDL WFL HSTYLE ORG-OORGN UPC 079893801155 SIMPLE TRUTH OR
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0541-2025·2024-12-04
Mammotrak Diagnostic Coil 1.5T Recalled Due to Patient Safety Concern
Philips is recalling 5,231 Mammotrak Diagnostic Coil 1.5T units nationwide because of a potential patient safety issue during MRI scans. The FDA has classified this as a Class II recall.
Product
Mammotrak Diagnostic Coil 1.5T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0178-2025·2024-12-04
Treehouse Foods Griddle Waffles Recalled for Potential Listeria Contamination
Treehouse Foods is recalling certain griddle waffle products due to potential Listeria monocytogenes contamination. Affected products were distributed nationwide in the USA and Canada.
Product
COMPLIMENTS 12/390g GRDL WFL BLGN MXD BRY-CMPLM UPC 055742347180 CULINARY TOURS 12/13.75oz GRDL WFL BLGN MXD BRY - CLNTR UPC 011225148569
Category
Food
Distribution
Distributed nationwide