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.

5276–5300 of 88106

  • CriticalFDA (Food)·H-0168-2026·2025-11-05

    Bulk frozen scrambled eggs recalled over potential Listeria monocytogenes contamination

    Echo Lake Foods is recalling 824 cases, 23,072 pounds, of bulk cage free precooked scrambled eggs over potential Listeria monocytogenes contamination. The FDA classified it Class I.

    Product
    EchoLakeFoods MF 3067 CNFREE Cage Free Precooked IAF Scrambled Eggs Net Wt. 28 lbs. Bulk. Keep Frozen. Manufactured by: Echo Lake Foods, Inc., 2319 Raymond Ave. Franksville, WI 53126.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·H-0138-2026·2025-11-05

    White chocolate coconut bundt cakes recalled over an undeclared wheat allergen

    Doan's Dessert And Coffee is recalling its 3 lb 12 oz White Chocolate Coconut Bundt Cake over an undeclared wheat allergen. The FDA has classified the recall as Class I.

    Product
    White Chocolate Coconut Bundt Cake - Net Weight 3 lbs 12 oz Contains: Wheat, Soy, Milk, Eggs No UPC
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0188-2026·2025-11-05

    Distal access catheters recalled after coating material lifting inside the lumen

    Balt USA is recalling 207 MEGA Ballast Distal Access Platform catheters over a manufacturing defect in which coating material lifts within the catheter's distal lumen. The FDA has classified it Class I.

    Product
    Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT091110 Software Version: N/A Product Description: The Mega Ballast 091 is designed with a semi-rigid proximal shaft and a highly…
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0317-2026·2025-11-05

    Magseed Pro 12 cm markers recalled over potential cotton fiber contamination

    Endomagnetics is recalling 540 Magseed Pro 12 cm soft tissue markers because of the potential for contamination with cotton fibers.

    Product
    Magseed Pro 12 cm soft tissue marker. Model Number: MS2-17-1-12. Product Description: The Endomag Magseed Pro Magnetic Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro Marker is indicated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0331-2026·2025-11-05

    Clave bag spikes recalled because port weld may separate and leak

    ICU Medical is recalling 200 Clave Bag Spikes with ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0329-2026·2025-11-05

    Universal vented vial spikes recalled because port weld may separate and leak

    ICU Medical is recalling 2,100 ChemoLock Universal Vented Vial Spikes because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0146-2026·2025-11-05

    Roasted mixed nuts recalled over hazelnuts missing from the allergen statement

    Severn Peanut Company is recalling 528 cases of 8 oz Roasted No Salt Mixed Nuts after finding hazelnuts were not listed in the allergen statement.

    Product
    MIXED NUTS Roasted No Salt NET WT 8 OZ (227g) INGREDIENTS: ALMONDS, WALNUTS, PEANUTS***CASHEWS***HAZELNUTS, BRAZIL NUTS CONTAINS: ALMONDS, BRAZIL NUTS, CASHEWS, PEANUTS, WALNUTS UPC 8 10111 02237 8 DIST BY: HAMPTON FARMS 180 AVOCADO ST. SPRINGFIELD, MA 01104
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0136-2026·2025-11-05

    Testosterone and triamcinolone 100 mg pellets recalled over metal particulate matter

    FarmaKeio Outsourcing is recalling 103,444 sterile Testosterone / Triamcinolone Acetonide 100MG/20MCG pellets over the potential presence of metal particulate matter.

    Product
    Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0367-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0129-2026·2025-11-05

    Testosterone 200 mg pellets recalled over potential metal particulate matter

    FarmaKeio Outsourcing is recalling 14,329 sterile Testosterone Regular Release 200 mg pellets over the potential presence of metal particulate matter.

    Product
    Testosterone Regular Release 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0402-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0139-2026·2025-11-05

    Cheddar caramel popcorn recalled over peanuts missing from the ingredient statement

    Jody's Inc. is recalling 8,244 units of Cabot Creamery Sea Salt Caramel Cheddar popcorn after two complaints that the product contains peanuts not listed in the ingredient statement.

    Product
    CaBOT CREAMERY SEA SALT CARAMEL CHEDDAR SWEET & CHEESY POPCORN 6.0oz bag CONTAINS: SOY & MILK UPC 8 50016 94430 6 MANUFACTURED FOR: VERMONT CHEESE PRODUCTS, INC 60 LAKE STREET, SUITE 2A BURLINGTON, VT 05401
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0131-2026·2025-11-05

    Combination hormone pellets recalled over potential presence of metal particulate matter

    FarmaKeio Outsourcing is recalling 36,924 sterile Testosterone / Triamcinolone Acetonide 25MG/5MCG pellets over the potential presence of metal particulate matter.

    Product
    Testosterone / Triamcinolone Acetonide 25MG/5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0379-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0357-2026·2025-11-05

    ChemoLock ports with Spiros recalled over port weld separation risk

    ICU Medical is recalling 2,000 ChemoLock Ports with Spiros and red cap because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0143-2026·2025-11-05

    Sodium chloride injection bags recalled over potential flexible container leaks

    Otsuka ICU Medical is recalling 509,360 100 mL bags of 0.9% Sodium Chloride Injection from one lot for lack of assurance of sterility due to potential flexible container leaks.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0099-2026·2025-11-05

    Adalimumab prefilled syringes recalled for lack of sterility assurance

    Samsung Bioepis is recalling 5,518 cartons, 11,036 prefilled syringes, of HADLIMA (adalimumab-bwwd) injection 40mg/0.8 mL from one lot for lack of assurance of sterility.

    Product
    HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for: Organon LLC, a subsidiary of ORGANON & Co, Jersey City, NJ 07302, Manufactured by: SAMSUN BIOEPIS Co., Ltd, Incheon, Republic of Korea, NDC 78206-183-01.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0311-2026·2025-11-05

    Trocar sealing units recalled over silicone fragments detaching from sealing component

    Aesculap is recalling 26 sealing units for 10/12mm trocars because silicone fragments may detach from the yellow sealing component.

    Product
    Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P Software Version: N/A Product Description: SEALING UNIT FOR 10/12MM TROCARS Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0360-2026·2025-11-05

    Graduated adapter extension sets recalled over port weld separation risk

    ICU Medical is recalling 5,700 7.5-inch extension sets with a ChemoLock port and graduated adapter because the port weld may separate or break during use and leak.

    Product
    ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0337-2026·2025-11-05

    Oncology transfer kits recalled over port weld separation risk

    ICU Medical is recalling 600 Oncology Transfer Kits with ChemoClave and ChemoLock ports because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0375-2026·2025-11-05

    CT scanners recalled over six software faults affecting movement and dose

    Philips Medical Systems is recalling 105 Incisive CT scanners on software versions 5.1.0.X and 5.1.1.X over six software issues, including unintentional gantry and couch movement.

    Product
    Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X;
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-0356-2026·2025-11-05

    Syringe transfer sets recalled because port weld may separate and leak

    ICU Medical is recalling 900 Syringe Transfer Sets with MicroClave and ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0348-2026·2025-11-05

    Closed vial spikes with skirt recalled over port weld separation risk

    ICU Medical is recalling 8,475 ChemoLock Closed Vial Spikes with Skirt because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0336-2026·2025-11-05

    Oncology kits with ChemoLock port recalled over port weld separation

    ICU Medical is recalling 150 Oncology Kits with ChemoLock and ChemoLock Port because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0341-2026·2025-11-05

    Chemotherapy bag spikes recalled because port weld may separate and leak

    ICU Medical is recalling 7,850 ChemoLock Bag Spikes because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock Bag Spike REF: CL-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0123-2026·2025-11-05

    Testosterone pellets recalled over potential presence of metal particulate matter

    FarmaKeio Outsourcing is recalling 1,329 sterile Testosterone 25 mg pellets from one lot over the potential presence of metal particulate matter.

    Product
    Testosterone 25MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0389-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0110-2026·2025-11-05

    Desipramine 75 mg tablets recalled over nitrosamine impurity above intake limit

    Heritage Pharmaceuticals is recalling 2,418 bottles of Desipramine Hydrochloride Tablets USP 75 mg because N-Nitroso Desipramine exceeded the permissible acceptable daily intake level.

    Product
    DESIPRAMINE HYDROCHLORIDE — DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0104-2026·2025-11-05

    Prazosin 1 mg capsules recalled over nitrosamine impurity above intake limit

    Teva Pharmaceuticals USA is recalling 181,659 bottles of Prazosin Hydrochloride Capsules 1 mg because test results for N-nitroso Prazosin impurity C exceeded the acceptable intake limit.

    Product
    PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide