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.

8201–8225 of 26961

  • HighFDA (Devices)·Z-0533-2025·2024-12-04

    Medline Surgical Implant Kits Recalled for Incorrect Suture Specifications

    Medline is recalling 360 surgical implant and thoracotomy kits because some suture packages contain incorrect needle types, sizes, or suture diameters and lengths. The affected kits were distributed to healthcare facilities in five states.

    Product
    (1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ904220F, 1 kit/case, non-sterile.
    Category
    Medical Device
    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-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-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-0195-2025·2024-12-04

    Frozen griddle waffles recalled for potential Listeria contamination

    Treehouse Foods recalls frozen griddle waffles nationwide due to potential Listeria monocytogenes contamination. Products with batch codes starting with 2C and best-by dates from October 1, 2024 to October 11, 2025 may be affected.

    Product
    IRRESISTIBLES LIFE SMART 12/240g GRDL WFL HSTYLE GF-IRRLS UPC 059749977661 GOOD & GATHER 12/11.3oz GRDL WFL HSTYLE GF-GDGTR UPC 085239157954 GIANT EAGLE 12/11.3oz GRDL WFL HSTYLE GF-GT/EG UPC 030034944933 PRESIDENT'S CHOICE 12/320g GRDL WFL HSTYLE GF-PCHOI UPC 060383038670 WILD H
    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 (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-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 (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 (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-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 (Food)·F-0167-2025·2024-12-04

    Gordon Food Service Waffle Mix Recalled Due to Potential Listeria Contamination

    Treehouse Foods is recalling 9.9 million cases of Gordon Food Service 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
    GORDON FOOD SERVICE 1/10.8lb GRDL WFL BLGN BFFT - GDNFS
    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 (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 (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-0547-2025·2024-12-04

    Philips ST SENSE Breast Coil Recalled for Potential Patient Safety Risk

    Philips is recalling 5,231 ST SENSE Breast Coils nationwide due to a potential safety issue that could harm patients during MRI scanning. Affected units are identified by specific serial numbers.

    Product
    ST SENSE Breast Coil
    Category
    Medical Device
    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-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 (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 (Devices)·Z-0570-2025·2024-12-04

    Arial Server Software Fails to Notify Users of Emergency Calls

    Securitas Healthcare's Arial Server Software versions 11.1.4 through 11.1.6 may fail to notify users when emergency calls are initiated through the Arial Nurse Call System, posing a patient safety risk.

    Product
    Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjunction with the Arial Mobile Application or Arial Care Giver Application
    Category
    Medical Device
    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-0190-2025·2024-12-04

    Natures Path Organic Griddle Waffles Recalled for Listeria Contamination

    Treehouse Foods is recalling Natures Path Organic griddle waffles with chia due to potential Listeria monocytogenes contamination. Approximately 9.9 million cases distributed nationwide in the USA and Canada are affected.

    Product
    NATURES PATH ORGANIC 12/7.4oz GRDL WFL CHIA ORG GF-NPTHO UPC 058449590729 NATURES PATH ORGANIC 12/210g GRDL WFL CHIA ORG GF-NPOCN UPC 058449590743
    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 (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