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.

10076–10100 of 88183

  • ModerateFDA (Devices)·Z-0646-2025·2024-12-11

    MEDLINE Surgical Kits Recalled Due to Defective SafeAir Component

    Medline is recalling 3,452 units of surgical convenience kits nationwide due to a defective SafeAir Smoke Evacuation Pencil component previously recalled by Stryker. No illnesses or injuries have been reported.

    Product
    MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2) LAVH CDS, REF CDS983411J; 3) MAJOR VAGINAL, REF CDS983497L; 4) DAY SURG LARGE VAG CDS, REF CDS984995N; 5) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 6) D&C/HYSTEROSCOPY PACK…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0102-2025·2024-12-11

    Prescription drug esomeprazole magnesium recalled for labeling error

    Zydus Pharmaceuticals is recalling esomeprazole magnesium oral suspension because of an incorrect NDC number on package labeling. The affected product is lot M408002 distributed nationwide.

    Product
    ESOMEPRAZOLE MAGNESIUM — ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0587-2025·2024-12-11

    BD COR PX Instrument Service Credentials Compromised; Update Required

    Becton Dickinson reports that technical support credentials for the BD COR PX Instrument were accessed by an unauthorized actor. Users should verify credential updates with BD to mitigate unauthorized access risk.

    Product
    BD COR PX Instrument Version or Model: 443988 Catalog Number: 443988
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0645-2025·2024-12-11

    MEDLINE C-Section Kits Recalled for Defective Smoke Evacuation Component

    MEDLINE is recalling 58,765 C-section convenience kits nationwide that contain SafeAir Smoke Evacuation Pencil components recalled by manufacturer Stryker. Affected kits have specific lot numbers.

    Product
    MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075V; 2) C-SECTION OR 30 CDS, REF CDS820075W; 3) C-SECTION, REF CDS980774M; 4) C-SECTION KIT, REF CDS981322AB; 5) C-SECTION KIT, REF CDS981322AC; 6) C-SECTION COMBINED CDS, REF CDS982398I; 7)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0648-2025·2024-12-11

    Medline Recalls Convenience Kits with Recalled SafeAir Smoke Evacuation Pencil

    Medline is recalling 1,921 medical convenience kits distributed nationwide that contain SafeAir Smoke Evacuation Pencil components previously recalled by Stryker.

    Product
    MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) EYE PACK, REF DYNJ41207C; 3) CATARACT PACK, REF DYNJ43147G; 4) OSC OCULOPLASTIC PACK, REF DYNJ63329D; 5) OSC OCULOPLASTIC PACK, REF DYNJ63329F; 6) OCULAR PACK, REF DYNJ64138B; 7) OSC…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0087-2025·2024-12-11

    MAXIM Assure Antibacterial Hand Soap Recalled for Microbial Contamination

    Midlab Incorporated is recalling MAXIM Assure Antibacterial hand soap (Lot 0711241) nationwide due to out-of-specification microbial test results in the manufacturing process.

    Product
    MAXIM Assure Antibacterial, Chloroxylenol 0.1%, Net Contents: One U.S. Gallon (3.78 L), For Industrial and Institutional Use Only, MIDLAB 140 Private Brand Way, Athens, TN 37303
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0637-2025·2024-12-11

    MEDLINE Burn Convenience Kits Recalled Due to Defective Component

    MEDLINE is recalling 486 burn convenience kits because they were manufactured using SafeAir Smoke Evacuation Pencil components that were previously recalled by Stryker.

    Product
    MEDLINE convenience kits labeled as: 1) BURN, REF CDS983465M; 2) BURN, REF CDS983465N; 3) BURN PACK, REF DYNJ63331D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0591-2025·2024-12-11

    BD Synapsys Laboratory Informatics System Recalled for Service Credential Compromise

    BD is recalling the Synapsys Informatics Solution Version 444150 due to compromised service credentials used by technical support teams. Unauthorized access may compromise data confidentiality, integrity, and system availability.

    Product
    BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0594-2025·2024-12-11

    BD BACTEC FX40 Product Service Credentials Accessed by Unauthorized Actor

    Unauthorized actor accessed BD technical support credentials for the BACTEC FX40 laboratory instrument. Until credentials are updated, there is a risk of unauthorized access to the system and associated data.

    Product
    BD BACTEC FX40 Instrument Version or Model: 442296 Catalog Number: 442296
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0642-2025·2024-12-11

    Medline Surgical Convenience Kits Recalled Over Supplier Component Recall

    Medline is recalling 336 surgical convenience kits manufactured with SafeAir Smoke Evacuation Pencils that Stryker previously recalled. The kits were distributed nationwide.

    Product
    MEDLINE convenience kits labeled as: 1) LITHOTOMY/PELVISCOPY PACK, REF DYNJ0531985R; 2) PELVISCOPY PACK-LF, REF DYNJ0843760I; 3) PELVISCOPY PACK-LF, REF DYNJ0843760J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0623-2025·2024-12-11

    Medline Medical Convenience Kits Recall Due to Recalled Component

    Medline is recalling certain medical convenience kits manufactured with SafeAir Smoke Evacuation Pencils that were previously recalled by Stryker. The recall affects 182 units distributed nationwide.

    Product
    MEDLINE medical convenience kits labeled as: 1) ACETABULAR PACK-LF, REF DYNJ0572894I; 2) LOCAL BASIC, REF DYNJ34418L; 3) LOCAL BASIC, REF DYNJ34418M; 4) MINI LOCAL, REF DYNJ900287D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0555-2025·2024-12-11

    Non-ablative Fractional Laser Systems WFB-01: Software Bug and Labeling Issues Recalled

    Non-ablative Fractional Laser Systems Model WFB-01 are recalled due to a software bug affecting 6 units sold to US customers before August 23, 2022, and labeling non-compliances affecting 22 units sold to US customers.

    Product
    Non-ablative Fractional Laser Systems, Model: WFB-01
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Food)·F-0216-2025·2024-12-04

    Atwater's Spider Web Tarts Recalled for Undeclared Almonds

    One Roof LLC recalls Atwater's Spider Web Tarts for undeclared almonds. Consumers with tree nut allergies should not consume this product.

    Product
    Atwater's Spider Web Tarts, 26 tarts packaged individually, 5.73 in x 5.95 in x 3 in clear plastic clamshell container, Julienne date 292
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0328-2025·2024-12-04

    Hologic BioZorb Radiographic Marker Recalled Due to Serious Injury Reports

    Hologic has recalled 12,710 BioZorb Markers nationwide after receiving reports of serious complications including infection, device migration, and device erosion. The FDA classified this as a Class I recall.

    Product
    BioZorb Marker. Radiographic soft tissue marker.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0148-2025·2024-12-04

    Onion Soup and Dip Mix Recalled for Undeclared Egg Allergen

    Bowl & Basket onion soup and dip mix is being recalled for containing undeclared egg allergen. The product was distributed to one customer in New Jersey. The manufacturer, Gilster-Mary Lee Corporation, initiated the recall voluntarily.

    Product
    Bowl & Basket onion soup and dip mix, net wt 2 oz (2-1oz pouches), UPC 041190083947, Distributed by: Wakefern Food Corp, 5000 Riverside Drive, Keasbey, NJ 08832
    Category
    Food
    Distribution
    1 state
  • 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-0168-2025·2024-12-04

    Good & Gather and Breakfast Best Griddle Waffles Recalled for Listeria Risk

    Treehouse Foods is recalling Good & Gather and Breakfast Best griddle waffles nationwide due to potential Listeria monocytogenes contamination. Affected batches have codes starting with 2C with best-by dates between October 1, 2024 and October 11, 2025.

    Product
    GOOD & GATHER 12/12.3oz GRDL WFL BLBRY-GDGTR UPC 085239157923 BREAKFAST BEST 12/12.3 OZ GRDL WFL BLBRY-BKBST UPC 4061464782273
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0063-2025·2024-12-04

    Drug recall: Absorbine Jr. Ultra Strength Pain Patch manufacturing deviations

    Absorbine Jr. Ultra Strength Pain Patch is being recalled nationwide due to manufacturing process deviations. The voluntary recall affects approximately 4,968,000 patches.

    Product
    ABSORBINE jr ULTRA STRENGTH PAIN PATCH, Menthol 6.5%, 1 patch per box, Distributed By: Absorbine Jr. LLC, Chattanooga, TN 37402 UPC 8 89476 41318 3, UPC 8 89476 41336 7
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0153-2025·2024-12-04

    Frozen griddle pancakes recalled for potential Listeria contamination

    Treehouse Foods is recalling frozen griddle pancakes from Wegmans, Yelloh, and Giant Eagle brands due to potential Listeria monocytogenes contamination. The products were distributed nationwide across the USA and Canada.

    Product
    WEGMANS 12/16.5oz GRDL PNCK BB-WEGMN UPC 077890481387 YELLOH 12/16.5oz GRDL PNCK BLBRY-YLLOH UPC 810038684680 GIANT EAGLE 12/16.5oz GRDL PNCK BLBRY-GT/EG UPC 030034011673
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0162-2025·2024-12-04

    H-E-B and Central Market Griddle Waffles Recalled for Listeria Risk

    H-E-B and Central Market brand griddle waffles with apple cinnamon are being recalled nationwide due to potential Listeria monocytogenes contamination affecting 9,907,389 cases.

    Product
    H-E-B 12/9oz GRDL WFL APL CIN ORG-HEBUT UPC 041220708376 CENTRAL MARKET 12/9oz GRDL WFL APL CIN ORG - CTMKT UPC 041220655748
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0192-2025·2024-12-04

    Kodiak Cakes Griddle Waffles Recalled for Potential Listeria Contamination

    Treehouse Foods is recalling Kodiak Cakes griddle waffles due to potential Listeria monocytogenes contamination. Affected products have batch codes starting with 2C with best by dates from October 1, 2024 to October 11, 2025.

    Product
    KODIAK CAKES 8/10.72oz GRDL WFL DRKCH REFORM-KDKCS UPC 705599012709
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0154-2025·2024-12-04

    Breakfast Best Griddle Pancakes Recalled for Potential Listeria Contamination

    Treehouse Foods is recalling Breakfast Best griddle pancakes nationwide due to potential Listeria monocytogenes contamination. Affected products have batch codes starting with 2C and Best By dates between October 1, 2024 and October 11, 2025.

    Product
    BREAKFAST BEST 8/33oz GRDL PNCK BDAY-BKBST UPC 4061459959116
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0155-2025·2024-12-04

    Pancake and Griddle Mix Recalled for Potential Listeria Contamination

    Multiple brands of griddle pancake and buttermilk mix made by Treehouse Foods are being recalled nationwide due to potential Listeria monocytogenes contamination. Consumers should not consume the affected products.

    Product
    GIANT EAGLE 8/33oz GRDL PNCK BTRMLK - GT/EG UPC 030034071332 SCHNUCKS 8/33oz GRDL PNCK BTRMLK - SCHNK UPC 041318100020 SE GROCERS 8/33oz GRDL PNCK BTRMLK - SEGGR UPC 038259117170 BROOKSHIRE'S 8/33oz GRDL PNCK BTRMLK - BRKSH UPC 092825096740 SIGNATURE SELECT 8/33oz GRDL PNCK…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0531-2025·2024-12-04

    AMS Artificial Urinary Sphincter Balloon Mislabeled With Wrong Component

    Boston Scientific recalls 52 mislabeled AMS Artificial Urinary Sphincter balloons that may contain a Control Pump instead of the labeled Pressure Regulating Balloon component.

    Product
    AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
    Category
    Medical Device
    Distribution
    Distributed nationwide