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.

6226–6250 of 52958

  • 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 (Devices)·Z-0508-2025·2024-12-04

    Medline Nexus Catheter Connectors May Fail to Open Properly

    Medline recalls 1,975 NEXUS catheter connectors that may not fully open, preventing proper catheter insertion. Affected units were distributed nationwide and internationally.

    Product
    MEDLINE NEXUS 19/20G CATH CONNECTOR, Medline SKU REF NEXCONNECT, Catheter Connector
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0515-2025·2024-12-04

    MEDLINE Epidural Procedure Kits: Connector May Prevent Catheter Insertion

    MEDLINE epidural trays used for labor anesthesia may have connectors that fail to fully open, preventing proper catheter insertion. The recall affects 2,592 units distributed across the US and internationally.

    Product
    MEDLINE procedure kits labeled as follows: 1) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699; 2) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0510-2025·2024-12-04

    Medline Epidural Catheter Kits Recalled Due to Connector Position Defect

    Medline is recalling over 5,900 epidural catheter kits because the connectors may not open fully, preventing proper catheter insertion. The recall affects units distributed nationwide and internationally.

    Product
    MEDLINE procedure kits labeled as follows: 1) 20G EPI CATH SINGLE STERILE, REF EPICATH19 2) 20G EPI CATH SINGLE STERILE, REF EPICATH20
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0513-2025·2024-12-04

    MEDLINE Epidural and Spinal Procedure Kits: Connector May Prevent Catheter Insertion

    MEDLINE is recalling 3,744 epidural and spinal procedure kits due to a connector defect that may prevent proper catheter insertion. Affected kits were distributed nationwide and internationally.

    Product
    MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF PAIN1069B; 2) CSE TRAY, REF PAIN1941; 3) TRAY CON EPID 20G NYL W/TUOHY, REF PAIN9023; 4) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN1281 5) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN9024
    Category
    Medical Device
    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-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-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 (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 (Food)·F-0165-2025·2024-12-04

    Griddle waffles recalled for potential Listeria monocytogenes contamination

    Treehouse Foods recalls griddle waffles for potential Listeria monocytogenes contamination affecting 9.9 million cases distributed nationwide.

    Product
    GIANT EAGLE 12/11.3oz GRDL WFL BCKWHE BLBRY GF-GT/EG UPC 030034944940 H-E-B HIGHER HARVEST 12/11.3oz GRDL WFL BCKWHE BLBRY GF-HEBHH UPC 041220708390 CENTRAL MARKET 12/11.3oz GRDL WFL BCKWHE BLBRY GF-CTMKT UPC 041220253654
    Category
    Food
    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 (Devices)·Z-0572-2025·2024-12-04

    TriALTIS Torque Limiter Ratchet Recalled for Excessive Torque Output

    Gauthier Biomedical is recalling the TriALTIS TORQUE LIMITER due to an out-of-specification component that may cause the device to produce higher torque output than intended. The recall affects 160 units.

    Product
    TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0175-2025·2024-12-04

    Kodiak Cakes Buttermilk Griddle Waffles Recalled for Potential Listeria Contamination

    Treehouse Foods is recalling Kodiak Cakes griddle waffles (UPC 705599014802) due to potential Listeria monocytogenes contamination. The product was distributed nationwide in the United States and Canada.

    Product
    KODIAK CAKES 8/14.8oz GRDL WFL BLGN BTRMLK VAN-KDKCS UPC 705599014802
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0158-2025·2024-12-04

    KRUSTEAZ Griddle Pancake Mix Recalled Nationwide for Potential Listeria Contamination

    Treehouse Foods is recalling KRUSTEAZ Griddle Pancake Mix due to potential Listeria monocytogenes contamination. Approximately 9,907,389 cases with batch codes starting with '2C' and Best By dates from October 1, 2024, through October 11, 2025, are affected.

    Product
    KRUSTEAZ 12/15oz GRDL PNCK MINI BTRMLK-KTZCM UPC 686151200164
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0174-2025·2024-12-04

    Griddle waffles recalled by Treehouse Foods for potential Listeria contamination

    Treehouse Foods is recalling Duncan Hines, Bakers Source, and Gordon Choice branded griddle waffles due to potential Listeria monocytogenes contamination. Products were distributed nationwide in the USA and Canada.

    Product
    DUNCAN HINES 1/3.41kg GRDL WFL BLGN 7IN-DUNHN UPC 091479060268 BAKERS SOURCE CANADA 1/3.41kg GRDL WFL BLGN 7IN - BKSCN GORDON CHOICE 1/3.41kg GRDL WFL BLGN ORIG-GDNCH
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0150-2025·2024-12-04

    Treehouse Foods Plant-Based Waffles Recalled for Listeria Contamination Risk

    Treehouse Foods is recalling BREAKFAST BEST plant-based waffles nationwide due to potential Listeria monocytogenes contamination. Affected products have batch codes starting with 2C and best-by dates from October 2024 through October 2025.

    Product
    BREAKFAST BEST 12/8 OZ GRDL HSTYLE PLNT BSD WFL-BKBST UPC 4061459885750
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0152-2025·2024-12-04

    Treehouse Foods Recalls Frozen Waffles for Potential Listeria Contamination

    Treehouse Foods is recalling BREAKFAST BEST frozen griddle waffles nationwide due to potential Listeria monocytogenes contamination. Approximately 9.9 million cases are affected; consumers should not eat the product.

    Product
    BREAKFAST BEST 12/12.3oz MXD CS GRDL WFL PMPKN/CINN-BKBST UPC 4061463257208
    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-0176-2025·2024-12-04

    Wegmans griddle waffles recalled for potential Listeria contamination

    Treehouse Foods recalled 9,907,389 cases of Wegmans griddle waffles 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
    WEGMANS 12/13.75oz GRDL WFL BLGN CIN - WEGMN UPC 077890550014
    Category
    Food
    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-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
  • HighFDA (Devices)·Z-0534-2025·2024-12-04

    Medline Shoulder Repair Pack-LF Recalled for Incorrect Surgical Components

    Medline is recalling Shoulder Repair Pack-LF surgical kits (lot 24ABO552) due to incorrect needle type/size and suture diameter/length in some packages. No patient injuries have been reported.

    Product
    Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0549-2025·2024-12-04

    Offset Cup Impactor Surgical Instruments Recalled for Weld Fracture

    INCIPIO DEVICES is recalling 100 units of Offset Cup Impactor surgical instruments (Lot 24A0087) because the TIG weld does not meet specifications and has fractured. These instruments are used in hip surgery to position acetabular cup implants.

    Product
    Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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