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.

1751–1775 of 88106

  • HighFDA (Devices)·Z-2532-2026·2026-07-01

    Acumed Hexalob Screws Recalled for Risk of Fracture During Use

    Acumed LLC is recalling Hexalob Screws of various sizes used with wrist fixation systems due to a manufacturing error that may cause the screws to break during use.

    Product
    Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Screw; 3070-27009 2.7mm x 9mm NL Hexalobe Screw; 3070-27010 2.7mm x 10mm NL Hexalobe Screw; 3070-27011 2.7mm x 11mm NL Hexalobe Screw; 3070-27012 2.7mm x 12mm NL Hexalobe Screw…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2572-2026·2026-07-01

    Surgify Halo Surgical Burr Recalled for Breakage Risk

    Surgify Halo 5.4 mm surgical burrs may break during bi-portal endoscopic spinal surgery. The FDA is recalling this device nationwide due to the potential breakage hazard.

    Product
    Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0628-2026·2026-07-01

    Perampanel Prescription Tablets Recalled for Labeling Mix-up

    Sun Pharmaceutical is recalling Perampanel 6 mg tablets due to labeling mix-up where 10 mg tablets were found in bottles labeled as 6 mg. Patients should verify their bottles with their pharmacy or physician.

    Product
    PERAMPANEL — PERAMPANEL (PERAMPANEL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1091-2026·2026-07-01

    Joy Mint Lassi 16 oz. recalled for inadequate pasteurization

    Joy Gourmet Foods LLC is recalling Joy Mint Lassi 16 oz. because the product was not adequately pasteurized, which may allow harmful bacteria to survive.

    Product
    Joy Mint Lassi 16 oz.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2571-2026·2026-07-01

    Surgify Halo surgical burrs recalled for potential breakage during spinal surgery

    Surgify Medical OY is recalling Surgify Halo 5.4 mm Long surgical burrs due to potential breakage during bi-portal endoscopic spinal surgery. The defect could affect patient safety during the procedure.

    Product
    Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2568-2026·2026-07-01

    Surgify Halo Surgical Burr Breakage Risk During Spinal Surgery

    Surgify Medical is recalling Surgify Halo 5.4 mm Medium surgical burrs due to potential burr breakage during bi-portal endoscopic spinal surgery. The device poses a risk of fragmentation that could complicate surgical procedures.

    Product
    Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2559-2026·2026-07-01

    Surgify Halo spinal surgery burr tool potential breakage recall

    Surgify Halo 4.0 mm extendable surgical burrs may break during bi-portal endoscopic spinal surgery. The device is being recalled to prevent patient injury from burr fragments.

    Product
    Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2566-2026·2026-07-01

    Surgify Halo Spinal Surgery Burrs Recalled for Breakage Risk

    Surgify Medical is recalling Surgify Halo 5.4 mm Short burrs (Model 54.070.NVG.H1) due to potential breakage during bi-portal endoscopic spinal surgery. The hazard could affect patient safety during the procedure.

    Product
    Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1133-2026·2026-07-01

    Boichik Bagels Pumpernickel Mix Bagels Recalled for Undeclared Sesame

    Boichik Bagels, Inc. is recalling Pumpernickel Mix Bagels (6-pack, 26.5 oz) due to undeclared sesame allergen on the label. Consumers with sesame allergies should not consume this product.

    Product
    boichik bagles Pumpernickel Mix Bagels 6 pre-sliced bagels NET WT 26.5 OZ (1.66 LB) 750g Ingredients: Organic wheat flour ... Contains Wheat Topped flavors may additionally contain ... sesame seeds ... Best by SE 26 26 UPC: 850016588067
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2564-2026·2026-07-01

    Surgify Halo Surgical Burrs Recalled Due to Breakage Risk

    SURGIFY MEDICAL OY is recalling Surgify Halo 5.4 mm Extendable surgical burrs (Model 54.000.SEE.H1) due to potential for burr breakage during bi-portal endoscopic spinal surgery. The device has been distributed nationwide.

    Product
    Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2569-2026·2026-07-01

    Surgify Halo Surgical Burrs Subject to Potential Breakage Recall

    Surgify Halo 5.4 mm surgical burrs may break during bi-portal endoscopic spinal surgery. The FDA has classified this as a Class II recall affecting devices distributed nationwide.

    Product
    Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2560-2026·2026-07-01

    Surgify Halo surgical burr recalled for potential breakage risk

    Surgify Medical is recalling the Surgify Halo 4.0 mm surgical burr because it may break during bi-portal endoscopic spinal surgery. The device is distributed nationwide.

    Product
    Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1083-2026·2026-07-01

    Joy Sweet Lassi 16 oz. Recalled for Inadequate Pasteurization

    Joy Gourmet Foods LLC is recalling Joy Sweet Lassi 16 oz. bottles due to inadequate pasteurization. The product was distributed in NY, NJ, and PA with expiry dates from June 30 through July 30, 2026.

    Product
    Joy Sweet Lassi 16 oz.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2586-2026·2026-07-01

    Medline Industries Polycarbonate Syringes Convenience Kits Design Change Recall

    Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA 510(k) clearance. Affected kits were distributed nationwide and internationally.

    Product
    Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAPHY PACK-LF DYNJ0854485S DEEP BRAIN STIMULATION PACK DYNJ0842793G NEURO ACCESSORY PACK DYNJ55385A NEURO ANGIO PACK DYNJ51697B DYNJ56509G DYNJ56509I…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2561-2026·2026-07-01

    Surgify Halo 4.0 mm Spinal Surgery Burrs May Break During Use

    Surgify Halo 4.0 mm Short burrs may break during bi-portal endoscopic spinal surgery, creating a potential hazard during the procedure. The FDA has classified this as a Class II recall affecting devices nationwide.

    Product
    Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1089-2026·2026-07-01

    Joy Plain Chaash Lassi recalled due to inadequate pasteurization

    Joy Gourmet Foods LLC is recalling Joy Plain Chaash Lassi in 16 oz. and 64 oz. sizes because the product was not adequately pasteurized, which may allow harmful bacteria to survive.

    Product
    Joy Plain Chaash Lassi 16 oz., 64 oz.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2570-2026·2026-07-01

    Surgify Halo surgical burrs recalled for potential breakage risk

    Surgify Medical is recalling the Surgify Halo 5.4 mm surgical burrs due to potential breakage during spinal surgery procedures.

    Product
    Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2530-2026·2026-07-01

    Zimmer Off-Axis Alliance Glenoid Reamer Guide Plastic Breakage Recall

    Zimmer, Inc. is recalling the Off-Axis Alliance Glenoid Left 4-Peg Augment Reamer Guide because the plastic guides can catch during reaming and break. Five complaints have been received.

    Product
    Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2553-2026·2026-07-01

    GE Healthcare AW Server Radiological Image Processing System Software Defect

    GE Healthcare is recalling the AW Server 3.2 ext. 6.5 radiological image processing system due to a software synchronization issue that may cause the wrong patient's images to be displayed without warning, potentially leading to misdiagnosis.

    Product
    GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2556-2026·2026-07-01

    Surgify Halo surgical drill equipment recalled for potential burr breakage

    Surgify Halo 3.0 mm Short surgical drills and burrs are being recalled because they may break during bi-portal endoscopic spinal surgery, potentially leaving fragments in the patient.

    Product
    Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1095-2026·2026-07-01

    Motor City Pizza Co. 5 Cheese Bread recalled for salmonella risk

    Champion Foods, LLC is recalling Motor City Pizza Co. 5 Cheese Bread due to potential salmonella contamination. Affected products were distributed nationwide at major retailers.

    Product
    Motor City Pizza Co. 5 Cheese Bread Single retail pack; 22.43 oz. (1 lb. 6.4 oz.) 636g UPC 8 70375 00511 1; 6 retail units per case Motor City Pizza Co. 5 Cheese Bread Twin retail pack; 44.86 oz. (2 lb. 12.9 oz.) 1272g UPC 8 70375 00509 8; 10 retail units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2528-2026·2026-07-01

    Zimmer Shoulder Reamer Guide System Recalled for Plastic Breakage

    Zimmer is recalling Off-Axis Comprehensive Shoulder System reamer guides (Model 110040241) because plastic guides can catch and break during reaming. Five complaints have been received.

    Product
    Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2580-2026·2026-07-01

    Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump recall

    Boston Scientific Corporation is recalling the Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump (model AP-0300H) due to potential leakage along the drug pathway from the pump through the catheter.

    Product
    Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1093-2026·2026-07-01

    Joy Orange Lassi 16 oz. Not Adequately Pasteurized Recall

    Joy Gourmet Foods LLC is recalling Joy Orange Lassi 16 oz. because the product was not adequately pasteurized, posing a potential health risk.

    Product
    Joy Orange Lassi 16 oz.
    Category
    Food
    Distribution
    3 states