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.

7876–7900 of 27089

  • HighFDA (Food)·F-0344-2025·2025-01-08

    Watermelon Halo Products Recalled for Potential Listeria Contamination

    King Kullen and Gracie's Kitchen brand Watermelon Halo products are being recalled due to potential Listeria monocytogenes contamination. The products were distributed in Connecticut and New York with sell-by dates from November 11 through November 21, 2024.

    Product
    a.) King Kullen brand Watermelon Halo; UPC: 85316-10392; 26 oz plastic container b.) Gracie's Kitchen brand Watermelon Halo; UPC: 85316-10392; 26 oz plastic container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0351-2025·2025-01-08

    Gracie's Kitchen Broccoli & Cauliflower Florets Recalled for Listeria

    Gracie's Kitchen brand Broccoli & Cauliflower Florets (12 oz foam trays) are being recalled due to potential Listeria monocytogenes contamination. The recalled products were distributed in Connecticut and New York.

    Product
    a.) Gracie's Kitchen brand Broccoli & Cauliflower Florets; UPC: 85316-1009; 12 oz foam tray
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0362-2025·2025-01-08

    Beef & Lamb Gyro Meal Kit Recalled for Salmonella Risk

    Reser's Fine Foods is recalling Beef & Lamb Gyro Sandwich Express Meal Kits due to potential Salmonella contamination in the tzatziki sauce. The recall affects 5,271 cases distributed across 19 states.

    Product
    Beef & Lamb Gyro Sandwich Express Meal Kit. Net wt. 31.8oz. UPC 0 13454 38313 1. Each kit contains 6 Pitas, Gyro Meat, Tzatziki Sauce 3oz. cups, Fire Feta Sauce, Feta Cheese Crumbles. Packaged in clear plastic clamshell. Distributed by Fresh Creative Foods, Vista CA.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-0324-2025·2025-01-08

    Multiple pineapple products recalled for potential Listeria contamination

    Gracie's Kitchens Inc. is recalling pineapple products sold under King Kullen, Wild By Nature, and Gracie's Kitchen brands in Connecticut and New York due to potential Listeria monocytogenes contamination.

    Product
    a.) King Kullen brand Pineapple Slices; UPC 85316-10007; 20 oz foam tray b) Wild By Nature brand Pineapple Slices; UPC: 85316-10007; 20 oz foam tray c.) King Kullen brand Pineapple Chunks; UPC: 85316-10386; 16 oz plastic container d.) King Kullen brand Pineapple Spears; UPC: 8531
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0774-2025·2025-01-08

    SynchroMed II and III Implantable Pumps Recalled for Software Issues

    Medtronic has recalled 3,981 SynchroMed implantable pumps worldwide due to software issues in application version 2.x used to program the devices.

    Product
    SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMSNG and PROG CT900E CLINICIAN TABLET PAPER EN with the A810 CP app version 2.x, CFN CT900E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0799-2025·2025-01-08

    Surgical spears recalled for potential sterile barrier defect

    Carwild Corporation recalls 300 Ivalon cellulose surgical spears (Model Q604237) due to potential package seal defects that could compromise sterility during ophthalmic surgical procedures.

    Product
    Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Food)·F-0341-2025·2025-01-08

    Tropical Fruit Cup Products Recalled for Possible Listeria Contamination

    King Kullen and Gracie's Kitchen brand tropical fruit cups may contain Listeria monocytogenes. Affected products were distributed in Connecticut and New York with sell-by dates from 11/11 to 11/21/24.

    Product
    a.) King Kullen brand Tropical Fruit Cup; UPC: 85316-10384; 16 oz plastic container b.) King Kullen brand Tropical Fruit Cup; UPC: 85316-10403; 12 oz plastic container c.) Gracie's Kitchen brand Tropical Fruit Cup; UPC: 85316-10384; 16 oz plastic container d.) Gracie's Kitchen br
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0773-2025·2025-01-08

    Medtronic Implantable Drug Pumps Recalled for Software Defects

    Medtronic has recalled 566 SynchroMed II and III implantable drug infusion pumps due to software issues in the controlling application. No injuries or illnesses have been reported.

    Product
    SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL with the A810 CP app version 2.x, CFN CT900D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0772-2025·2025-01-08

    SynchroMed II and III implantable pumps recalled for software issues

    Medtronic recalled SynchroMed II and III implantable pumps for software issues in the clinician tablet application. Fifty-nine systems are affected.

    Product
    SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with the A810 CP app version 2.x, CFN CT900C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0792-2025·2025-01-08

    Medline Medical Procedure Kits Recalled for Non-Sterile Component Contamination

    Medline Industries is recalling 2,664 custom medical procedure kits containing non-sterile surgical components with potential endotoxin contamination. The affected kits were distributed in the US, UAE, and Canada.

    Product
    Medline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF, REF DYNJ47568B; 2) UROLOGY ROBOTIC, REF DYNJ55555D; 3) KIT,SPINE LH, REF DYNJ906448A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0793-2025·2025-01-08

    Medline custom surgical procedure kits recalled for non-sterile components

    Medline is recalling 182 custom surgical procedure kits containing non-sterile Codman Surgical Patties and Strips with potential endotoxin contamination. The kits were distributed in the US, UAE, and Canada.

    Product
    Medline custom medical procedure kits labeled as: 1) CERVICAL PACK-LF, REF DYNJ0867145G; 2) CERVICAL SPINE PACK HUM-LF, REF DYNJ35184F; 3) ANTERIOR CERVICAL-CORPECTOMY, REF DYNJ904827.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0173-2025·2025-01-08

    Ketamine injection syringes recalled due to missing tamper-evident seals

    Hikma Injectables is recalling 1,800 ketamine injection syringes nationwide because tamper-evident seals are not attached to several syringes, compromising sterility assurance.

    Product
    ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, This is a Compounded Drug. Hospital/Office Use Only. NDC 63037-137-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0780-2025·2025-01-08

    Medline custom surgical procedure kits recalled for non-sterile components and endotoxin contamination

    Medline custom procedure kits containing non-sterile Codman Surgical Patties & Strips are being recalled due to potential endotoxin contamination. The recall affects 74 units distributed in the US, UAE, and Canada.

    Product
    Medline custom medical procedure kits labeled as: 1) UMC DR. BAKER SUPPLEMENT, REF DYNJ69476; 2) DIEP FLAP, REF DYNJ910120
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0338-2025·2025-01-08

    Mixed Fruit Products Recalled for Listeria Contamination Risk

    Gracie's Kitchens Inc. is recalling multiple brands of mixed fruit products due to potential Listeria monocytogenes contamination. Affected products were sold in Connecticut and New York with sell-by dates of November 11-21, 2024.

    Product
    a.) King Kullen brand Mixed Fruit; UPC: 85316-10376; 12 oz plastic container b.) King Kullen brand Mixed Fruit; UPC: 85316-10385; 16 oz plastic container c.) Wild By Nature brand Mixed Fruit; UPC: 85316-10376; 12 oz plastic container d.) Wild By Nature brand Mixed Fruit; UPC: 853
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0776-2025·2025-01-08

    Baxter Infusion Pump Recalled for Incomplete Post-Repair Testing

    Baxter Healthcare is recalling certain infusion pumps that were released after repair without complete testing. Incomplete testing could affect how the device delivers medication to patients.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0798-2025·2025-01-08

    Ophthalmic Surgical Device Recalled for Potential Sterile Barrier Compromise

    Carwild Corporation is recalling Ivalon Eye Wick 20cm surgical devices due to package seals that are out of specification and cannot guarantee sterile barrier integrity for the life of the product.

    Product
    Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from the Opthalmic surgical site. Model Number: Q604206
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0785-2025·2025-01-08

    Medline surgical procedure kits recalled for potential endotoxin contamination

    Medline is recalling three custom surgical procedure kits due to non-sterile Codman Surgical Patties and Strips that pose a potential endotoxin contamination risk. The affected kits were distributed in the US, Canada, and the UAE.

    Product
    Medline custom medical procedure kits labeled as: 1) PANENDOSCOPY-LF, REF DYNJ36728C; 2) ENDOSCOPIC SINUS PACK, REF DYNJ40644A; 3) ENDO SINUS PACK, REF DYNJ66449.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0331-2025·2025-01-08

    Peppers & Onions Products Recalled for Listeria Contamination Risk

    Multiple brands of peppers & onions products are being recalled due to potential Listeria monocytogenes contamination. Affected products were distributed in Connecticut and New York.

    Product
    a.) King Kullen brand Peppers & Onions; UPC: 85316-10087; 12 oz plastic container b.) Wild by Nature brand Peppers & Onions; UPC: 85316-10087; 12 oz plastic container c.) Gracie's Kitchen brand Peppers & Onions; UPC: 85316-10001; 12 oz plastic container d.) Gracie's Kitchen brand
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0325-2025·2025-01-08

    Cantaloupe products recalled due to potential Listeria monocytogenes contamination

    Gracie's Kitchens Inc. is recalling cantaloupe slices and chunks sold under King Kullen, Wild By Nature, and Gracie's Kitchen brands due to potential Listeria monocytogenes contamination. Products were distributed in Connecticut and New York.

    Product
    a.) King Kullen brand Cantaloupe Slices; UPC 85316-10008; 20 oz foam tray b) Wild By Nature brand Cantaloupe Slices; UPC: 85316-10008; 20 oz foam tray c.) King Kullen brand Cantaloupe Chunks; UPC: 85316-10379; 12 oz plastic container d.) King Kullen brand Cantaloupe Chunks; UPC:
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0339-2025·2025-01-08

    Mango Products Recalled for Potential Listeria Contamination

    Multiple mango brands sold in Connecticut and New York are being recalled due to potential Listeria monocytogenes contamination. Consumers should discard affected products or return them to retailers.

    Product
    a.) King Kullen brand Mango; UPC: 85316-10377; 12 oz plastic container b.) King Kullen brand Mango Spears; UPC: 85316-10387; 16 oz plastic container c.) Wild by Nature brand Mango; UPC: 85316-10377; 12 oz plastic container d.) Gracie's Kitchen brand Mango Spears; UPC: 85316-10337
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0366-2025·2025-01-08

    Minnesota Milk Bank Donor Human Milk Recalled for Undetermined Foreign Material

    Minnesota Milk Bank for Babies is recalling 136 bottles of pasteurized donor human milk due to potential contamination with undetermined foreign material. The affected batch (002237-1) expires 01/01/2025.

    Product
    MN Milk Bank for Babies Pasteurize Donor Human Milk. Volume: 4 fl. oz. / 120 ml. Milk Type: 20 kcal/oz. 1.0 g/dL Total Protein. MN Milk Bank for Babies, Roseville, MN 55113
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0779-2025·2025-01-08

    Medline Surgical Procedure Kits Recalled for Non-Sterile Components

    Medline is recalling custom surgical procedure kits containing non-sterile surgical components with potential endotoxin contamination. The recall affects 1,402 units distributed in the US, Canada, and UAE.

    Product
    Medline custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS983470D; 2) 1/2X1/2 NEURO SPONGE PACK-LF, REF DYNJ0713177; 3) BURR HOLE SHUNT PACK, REF DYNJ56819D; 4) BURR HOLE SHUNT PACK, REF DYNJ56819F; 5) BURR HOLE SHUNT PACK, REF DYNJ56819G; 6) RO VP SH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0796-2025·2025-01-08

    Rigid Intracardiac Sucker Units Recalled for Potential Sterility Breach

    Med Michigan Holding recalls SUC-4300S Rigid Intracardiac Suckers due to incomplete or partial pouch seals that may compromise sterility during cardiac surgery.

    Product
    SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use only to remove excess fluid from the surgical field.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0797-2025·2025-01-08

    3M Unitek Orthodontic Primer Recalled Due to Bond Failures and Skin Irritation

    3M Unitek is recalling Transbond Plus Self-Etching Primer used in orthodontic bonding due to reports of bracket bond failures and skin irritation or blistering.

    Product
    3M Unitek Transbond Plus Self-Etching Primer REF 712-090 (100 unit box) 712-091 (20 unit box) Transbond Plus Self Etching Primer is an orthodontic all-in-one etchant and primer that is used in the bonding process of orthodontic appliances to teeth.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0328-2025·2025-01-08

    Diced Celery Products Recalled Due to Potential Listeria Contamination

    Gracie's Kitchens Inc. is recalling multiple brands of diced celery sold in Connecticut and New York due to potential Listeria monocytogenes contamination.

    Product
    a.) King Kullen brand Diced Celery; UPC: 85316-10083; 12 oz plastic container b.) Wild By Nature brand Diced Celery; UPC: 85316-10083; 12 oz plastic container c.) Gracie's Kitchen brand Diced Celery: UPC: 85316-10020; 10 oz plastic container d.) Gracie's Kitchen brand Diced Celer
    Category
    Food
    Distribution
    2 states