The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

10201–10225 of 88183

  • 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 (Food)·F-0210-2025·2024-12-04

    Trader Joe's Griddle Waffles Pumpkin Recalled for Listeria Contamination Risk

    Treehouse Foods is recalling Trader Joe's Griddle Waffles Pumpkin due to potential Listeria contamination. About 9.9 million cases with batch codes starting with 2C and best-by dates October 1 through October 11, 2025, are affected.

    Product
    TRADER JOE'S 24/9.9oz GRDL WFL PMPKN - TRDJO UPC 000000517263
    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…
    Category
    Food
    Distribution
    Distributed nationwide
  • 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 (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-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…
    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…
    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-0526-2025·2024-12-04

    Karl Storz surgical instruments recalled for sterility barrier defect

    Karl Storz Endoscopy has recalled 105 surgical instruments with holes in their sterility barriers. The defect may compromise product sterility; affected devices were distributed nationwide and internationally.

    Product
    4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 28206CBS Full Radius Resector, sterile, 6x 5.5 x 120 mm REF 28205NDS Aggr. Pro Line Shaver Blade, sterile, 6x 5.5 x 120 mm REF 20205FDS Round Burr, sterile, 6x 6.5 x 120 mm REF 28205HES…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0173-2025·2024-12-04

    Blueberry protein waffles recalled for potential Listeria contamination

    Multiple brands of frozen blueberry protein waffles are being recalled due to potential Listeria monocytogenes contamination. Products were distributed nationwide in the USA and Canada.

    Product
    H-E-B HIGHER HARVEST 12/10.72oz GRDL WFL BLBRY PRTN-HEBHH UPC 041220708093 BETTERGOODS 12/10.72oz GRDL WFL BLBRY PRTN-BTRGD UPC 194346252756 SIMPLE TRUTH 12/10.72oz GRDL WFL BLBRY PRTN - SMPTR UPC 011110108142 BREAKFAST BEST 12/13.4oz GRDL WFL BLBRY PRTN-BKBST UPC 4099100312997
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0509-2025·2024-12-04

    MEDLINE Epidural and Spinal Anesthesia Procedure Kits: Connector Insertion Issue

    Multiple MEDLINE procedure kits used for epidural and spinal anesthesia have connectors that may not open fully, preventing proper catheter insertion during medical procedures.

    Product
    MEDLINE procedure kits labeled as follows: 1) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268B; 2) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268C; 3) FEMORAL BLOCK TRAY, REF DYNJRA1739A; 4) FEMORAL BLOCK TRAY, REF DYNJRA1739B; 5) 18G CPNB 20G STYLETED CATHETER, REF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0567-2025·2024-12-04

    Baxter MiniCap PD Transfer Set Recalled for Female Connector Separation

    Baxter Healthcare is recalling 1,496 units of MiniCap Extended Life PD Transfer Sets due to reports of female connector separation. The affected lots should not be used until assessed by Baxter.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0171-2025·2024-12-04

    Simple Truth Griddle Waffles Recalled for Potential Listeria Contamination

    Treehouse Foods is recalling Simple Truth Griddle Waffle Blueberry products nationwide due to potential Listeria monocytogenes contamination. Consumers should discard affected packages.

    Product
    SIMPLE TRUTH 12/11.3oz GRDL WFL BLBRY GF-SMPTR UPC 011110105509
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0516-2025·2024-12-04

    RENASYS EDGE Pump Recall Due to Battery Charging Failure Risk

    Smith & Nephew recalls 1,589 RENASYS EDGE wound therapy pumps due to battery charging failure if not properly maintained. Affected patients may experience treatment interruption.

    Product
    RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and body fluids, wound exudate and infectious materials.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Food)·F-0182-2025·2024-12-04

    Refrigerated griddle waffles recalled nationwide for potential Listeria contamination

    Treehouse Foods is recalling multiple brands of refrigerated griddle waffles nationwide due to potential Listeria monocytogenes contamination. Affected products have batch codes starting with 2C.

    Product
    PICS BY PRICE CHOPPER 6/29.6oz GRDL WFL BTRMLK RF - PRCHP UPC 041735064905 FOOD LION 8/12.3oz GRDL WFL BTRMLK RF-FDLIN UPC 035826091468 HANNAFORD 8/12.3oz GRDL WFL BTRMLK RF-HANNA UPC 041268196302 FOODHOLD 8/12.3oz GRDL WFL BTRMLK RF-FDHLD UPC 688267073960 SIGNATURE SELECT…
    Category
    Food
    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-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
  • HighFDA (Devices)·Z-0568-2025·2024-12-04

    Baxter Dialysis Transfer Set Recalled for Connector Separation

    Baxter Healthcare is recalling its MiniCap Extended Life PD Transfer Set (Part Number T5C4325K) due to increased complaints about the female connector separating from the main body of the device.

    Product
    Baxter MiniCap Extended Life PD Transfer Set (long) with Titanium Spike, Part Number T5C4325K; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    0 states
  • 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
  • ModerateFDA (Drugs)·D-0075-2025·2024-12-04

    Menthol pain relief patches recalled for manufacturing practice violations

    J.R. Watkins is recalling Cooling Menthol Extra Strength Pain Relief Patches nationwide due to manufacturing practice deviations. The recall affects approximately 7,138 patches from lots JC101, JC102, and JC103.

    Product
    Cooling Menthol Extra Strength Pain Relief Patch, Menthol 7.5%, packaged in box of 5, Distributed by J.R. Watkins LLC, Oakland CA 94612 UPC 8 56294 00878 5, NDC 72342-100-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0072-2025·2024-12-04

    Parche Leon pain relief patches recalled for manufacturing deviations

    Unexo Life Sciences Private Limited is voluntarily recalling Parche Leon pain relief patches due to manufacturing practice deviations. No illnesses or injuries have been reported.

    Product
    PARCHE LEON — PARCHE LEON (CAPSAICIN, CAMPHOR, MENTHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0551-2025·2024-12-04

    Abbott Merlin@home Cardiac Monitoring Transmitters Fail to Update After Power Loss

    Abbott is recalling 130 Merlin@home cardiac transmitters that cannot update software after power interruption during firmware download. Affected devices remain on outdated firmware with no ability to receive future updates.

    Product
    Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted heart device to Merlin.net" Patient Care Network (PCN) to facilitate remote monitoring by using inductive (EX1100 Model) or RF telemetry…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0554-2025·2024-12-04

    Shimadzu Autosampler Devices Subject to Water Damage Affecting Main Board

    Water condensation may accumulate under the autosampler's thermal insulation and damage the main board, causing communication errors and delays in laboratory testing. Two Shimadzu models are affected: SIL-40C XR CL and SIL-40C X3 CL.

    Product
    Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0074-2025·2024-12-04

    Drug Lice Treatment Recalled Due to Manufacturing Practice Violations

    Neogen Corporation has voluntarily recalled LICEOUT liquid lice treatment due to manufacturing practice violations. The recall affects 8,328 jugs distributed to institutions.

    Product
    LICEOUT, Liquid Lice Treatment for Human Use, Contents: 128 FL OZ. (3785.4 mL mL) per jug, Distributed By: Bob Barker Company, Inc., 7925 Purfoy Road, Fuquay-Varina, NC 27526. NDC: 53247-124-02
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0073-2025·2024-12-04

    FDA Drug Recall: LICEOUT Liquid Lice Treatment for Manufacturing Violations

    Neogen Corporation voluntarily recalled 5,328 sachets of LICEOUT lice treatment due to manufacturing practice violations. The product was distributed to Bob Barker Company for institutional facilities.

    Product
    LICEOUT, Liquid Lice Treatment for Human Use, Contents: 1 FL. OZ. (29.6 mL) per sachet, Distributed By: Bob Barker Company, Inc., 7925 Purfoy Road, Fuquay-Varina, NC 27526. NDC: 53427-124-01
    Category
    Drug
    Distribution
    0 states