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.

8476–8500 of 27089

  • CriticalFDA (Food)·F-0217-2025·2024-11-27

    Frozen U-BAKE Apple Pie recalled for undeclared egg allergen

    Grand Central Bakery FRE Co Inc is recalling 150 packages of U-BAKE Apple Pie due to undeclared egg. The product label declares wheat and milk but not egg, posing a serious risk to consumers with egg allergies.

    Product
    U-BAKE Apple Pie, frozen product and packaged in LDPE bag, net wt. 2lbs. 9oz. Made by Grand Central Baking Company. Label declares Wheat and Milk.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Devices)·Z-0382-2025·2024-11-27

    Baxter Peritoneal Dialysis Transfer Sets Recalled for Chemical Exposure

    Baxter Healthcare Corporation is recalling 1,240 units of MiniCap Extended Life PD Transfer Sets (Part Number T5C4484) due to potential exposure to polychlorinated biphenyls and related compounds when used in peritoneal dialysis treatments.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short, Part Number T5C4484; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0379-2025·2024-11-27

    Baxter MiniCap Dialysis Transfer Sets Recalled for PCB Exposure Risk

    Baxter is recalling MiniCap Extended Life PD Transfer Sets used in peritoneal dialysis due to potential exposure to polychlorinated biphenyls (PCBs). About 62,394 units distributed worldwide may be affected.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0220-2025·2024-11-27

    Frozen Chicken Pot Pie Recalled for Undeclared Egg Allergen

    U-BAKE Chicken Pot Pie frozen packages are being recalled because they contain undeclared egg, a common allergen. Consumers with egg allergies should not consume this product.

    Product
    U-BAKE Chicken Pot Pie, frozen product and packaged in heat-sealable polypropylene film. Net wt. 11.5oz. Made by Grand Central Baking Company. Label declares Wheat and Milk.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0219-2025·2024-11-27

    FDA Recalls U-BAKE Frozen Marionberry Pie for Undeclared Egg

    Grand Central Bakery is recalling U-BAKE Marionberry Pie due to undeclared egg, a major allergen not listed on the label. The recall affects 336 packages distributed in Oregon and Washington with expiration dates from February 1 to April 17, 2025.

    Product
    U-BAKE Marionberry Pie, frozen product and packaged in LDPE bag, net wt. 2lbs. 4oz. Made by Grand Central Baking Company. Label declares Wheat and Milk.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0373-2025·2024-11-27

    Peritoneal Dialysis Transfer Set Recalled for PCB Contamination Risk

    Baxter Healthcare recalls peritoneal dialysis transfer sets (Part Number 5C4482) due to potential contamination with polychlorinated biphenyls (PCBs). The recall affects 2.7 million units distributed worldwide.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0375-2025·2024-11-27

    Baxter peritoneal dialysis transfer set recalled for PCB exposure risk

    Baxter MiniCap Extended Life PD Transfer Sets (Part 5C4482S) are being recalled due to potential exposure to polychlorinated biphenyls (PCBs). The FDA Class I recall affects 151,020 units distributed worldwide.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0218-2025·2024-11-27

    Frozen Pie Crust and Bulk Dough Recalled for Undeclared Egg

    Grand Central Bakery is recalling U-BAKE frozen pie crust and bulk pie dough because they contain undeclared egg. The recall affects products distributed in Oregon and Washington.

    Product
    U-BAKE Pie Crust (Pastry Round), frozen product and packaged in LDPE bag, 2-10.5 inch pie crust per package, net wt. 20oz. Made by Grand Central Baking Company. Label declares Wheat and Milk. Bulk pie dough rolls, packaged in plastic wrap and parchment paper, net wt. 10lbs. Mad
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0482-2025·2024-11-27

    Medical Device Recall: Counterfeit Batteries in Plum Infusion Systems

    Counterfeit CSB batteries are being used in Plum Infusion Systems. These unauthorized batteries fail to hold their charge and have not been tested for use with the pumps.

    Product
    Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion System, Pump List Number 30010; Plum A+ & Plum A+3" Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 1197
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0377-2025·2024-11-27

    Baxter Peritoneal Dialysis Transfer Set Recalled for PCB Contamination Risk

    Baxter Healthcare is recalling the MiniCap Extended Life PD Transfer Set due to potential exposure to polychlorinated biphenyls (PCBs). Approximately 410,862 units are affected.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0378-2025·2024-11-27

    Baxter MiniCap Peritoneal Dialysis Transfer Set recalled for potential PCB exposure

    Baxter Healthcare is recalling 58,680 units of its MiniCap Extended Life PD Transfer Set due to potential exposure to polychlorinated biphenyls (PCBs). Users should stop using affected units and consult their healthcare provider.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0140-2025·2024-11-27

    Great Value Cheese Danish Recalled for Plastic Pieces

    Great Value Cheese Danish is being recalled due to plastic pieces found in the product. Consumers who purchased this item should discard it.

    Product
    Great Value Cheese Danish 16.5 oz UPC 078742201177, 12 retail units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0476-2025·2024-11-27

    FDA Recalls Posi-Stop Injection Needles Due to Manufacturing Debris

    Hobbs Medical is recalling Posi-Stop Injection Needles (25 gauge) because some units contain debris in the needle shaft that blocks injection solution flow.

    Product
    Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4723
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0053-2025·2024-11-27

    Prescription Drug Recall: Ramipril Capsules from Unapproved Supplier

    Lupin Pharmaceuticals is recalling certain lots of Ramipril 5 mg capsules because the active ingredient was sourced from an unapproved vendor, raising concerns about product quality and safety.

    Product
    RAMIPRIL — RAMIPRIL (RAMIPRIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0468-2025·2024-11-27

    Posi-Stop Injection Needles Recalled for Manufacturing Debris Blocking Flow

    Hobbs Medical is recalling Posi-Stop Injection Needles because manufacturing debris blocks the needle, preventing injection solutions from flowing properly. The 70 affected units were distributed to healthcare facilities in multiple U.S. states and Canada.

    Product
    Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0466-2025·2024-11-27

    Smiths Medical CADD-Solis AC adapter input plugs pose electrical shock risk

    Smiths Medical is recalling 156,400 CADD-Solis AC adapters due to damaged or broken input plugs that may expose metal contacts. The affected adapters could pose a risk of electrical shock or fire.

    Product
    smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion pumps
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0060-2025·2024-11-27

    Docusate Sodium 250 mg softgels recalled due to defective blister packaging

    Safecor Health is recalling Docusate Sodium 250 mg softgels due to manufacturing defects where blister card-foils separated from the medication cavity, potentially compromising product integrity.

    Product
    Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0472-2025·2024-11-27

    Posi-Stop Injection Needle Recalled Due to Manufacturing Debris Blockage

    Hobbs Medical is recalling Posi-Stop Injection Needles (23 Gauge, Lot H11-23-057) because some units contain manufacturing debris that blocks the needle opening, preventing injection solutions from flowing properly.

    Product
    Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4721
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0142-2025·2024-11-27

    BELEVINI Dried Fruit Mix Recalled Due to Undeclared Sulfites

    BELEVINI dried fruit mix (apples, pears, plums) is being recalled because it contains undeclared sulfites. Consumers with sulfite sensitivity should not consume this product.

    Product
    BELEVINI, DRIED FRUIT MIX (Apples, Pears & Plums w/pit), 500g, PLASTIC SOFT PACK, 6 PACKAGES PER CASE
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0467-2025·2024-11-27

    Bard Marquee Biopsy Instruments Recalled for Potential Needle Detachment

    Bard Peripheral Vascular Inc. is recalling Bard Marquee Disposable Core Biopsy Instrument Kits due to a manufacturing defect where some units lack a needle retention feature, risking detachment during use and potential tissue damage or bleeding.

    Product
    Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210; BARD MARQUEE 12G X 10 CM, REF: MQ1210; BARD MARQUEE Kit 12G X 13 CM, REF: MQK1213; BARD MARQUEE 12G X 13 CM, REF: MQ1213
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0055-2025·2024-11-27

    Prescription Dextroamphetamine Patches Recalled for Defective Adhesive System

    Noven Pharmaceuticals Inc is recalling 685 boxes of XELSTRYM (dextroamphetamine) transdermal patches nationwide due to a defect in the adhesive delivery system. The product does not meet manufacturing specifications.

    Product
    XELSTRYM — XELSTRYM (DEXTROAMPHETAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0506-2025·2024-11-27

    Z-800 Infusion System Recalled for Battery Depletion Risk

    Zyno Medical is recalling 34,994 units of the Z-800 Infusion System due to battery depletion risk from self-discharge and parasitic leakage current. The battery may not retain charge despite continuous AC power, potentially affecting device operation.

    Product
    Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision of a physician or other certifie
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0492-2025·2024-11-27

    Abbott Navitor Transcatheter Aortic Heart Valve Recalled for Manufacturing Defect

    Abbott Medical is recalling the Navitor 29mm transcatheter aortic heart valve due to a manufacturing error affecting leaflet specifications. The defect could potentially impact long-term valve durability or cause valve failure.

    Product
    Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0485-2025·2024-11-27

    Acrobat SUV Vacuum Stabilizer System Sterile Barrier Compromise Recall

    Maquet Cardiovascular is recalling the Acrobat SUV Vacuum Stabilizer System (Model C-OM-9000Z) due to manufacturing deviations that compromise the sterile barrier. Sterility cannot be assured during the 2-year shelf life, affecting approximately 10,778 units.

    Product
    Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
    Category
    Medical Device
    Distribution
    Distributed nationwide