Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

9801–9825 of 27638

HighFDA (Devices)·Z-0507-2025·2024-12-04
V.A.C. Ulta Therapy Units Recalled Due to Occlusion Sensor Failures
KCI USA is recalling 83,721 V.A.C. Ulta Negative Pressure Wound Therapy Units due to broken occlusion sensors that may prevent the device from initiating therapy. Affected units are distributed worldwide.
Product
V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.
Category
Medical Device
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 (Devices)·Z-0536-2025·2024-12-04
Philips Achieva TX Interventional Coil 3.0T Recalled for Patient Safety Risk
Philips recalls the Achieva TX Interventional Coil 3.0T (5,231 units) for a potential safety issue that may harm patients during MRI scan preparation or procedures.
Product
Achieva TX Interventional Coil 3.0T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0188-2025·2024-12-04
Kodiak Cakes Griddle Waffles Recalled for Potential Listeria Contamination
Treehouse Foods is recalling Kodiak Cakes griddle waffles due to potential Listeria monocytogenes contamination. The product was distributed nationwide in the USA and Canada.
Product
KODIAK CAKES 8/14.8oz GRDL WFL BLGN CHOC CHIP-KDKCS UPC 705599015137
Category
Food
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-0562-2025·2024-12-04
Baxter MiniCap Peritoneal Dialysis Sets Recalled for Connector Separation
Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets due to increasing reports of the female connector separating from the main body. The defect affects 62,718 units distributed worldwide.
Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis
Category
Medical Device
Distribution
0 states
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-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-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-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 (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-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 (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 (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-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-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 (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-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 (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
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-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-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 (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

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9801–9825 of 27638