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.

17601–17625 of 27263

  • HighFDA (Food)·F-0715-2023·2023-04-19

    Frozen Raspberries Recalled Due to High Levels of Mold

    Multiple frozen raspberry products from B.C. Frozen Foods (Nature's Promise Organic, Stater Bros., SB, and Sunny Select brands) are being recalled due to high levels of mold contamination.

    Product
    1. Nature's Promise Organic Raspberries 10oz; Stand up plastic pouch in corrugated box; Product of Chile; 8x12 oz bags per case; 2. Stater Bros. Red Raspberries 12oz; Stand up plastic pouch in corrugated box; Product of USA; 12x12 oz bags per case; 3. SB Raspberries 12 oz; Stan
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1382-2023·2023-04-19

    Philips DigitalDiagnost C50 Radiographic System Ceiling Suspension Malfunction Risk

    The Philips DigitalDiagnost C50 radiographic system's ceiling suspension may descend unintentionally if annual maintenance is skipped and power is interrupted, potentially injuring patients and operators.

    Product
    Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0717-2023·2023-04-19

    Butterball Turkey Stick Meal Kits Recalled for Possible Metal Shavings

    E S Foods is recalling Butterball Turkey Stick meal kits nationwide due to possible bronze metal shavings in the animal crackers. Consumers should not consume these products.

    Product
    61404 Butterball Turkey Stick MB (meal box)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0722-2023·2023-04-19

    Meal Kits With Animal Crackers Recalled for Metal Shavings

    E S Foods is recalling meal kits nationwide due to potential bronze metal shavings in the animal crackers component. No illnesses have been reported.

    Product
    61119 RS Cinnamon Toast Crunch BB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0803-2023·2023-04-19

    Protein bars recalled nationwide for undeclared cashew allergen

    Wellness Natural USA Inc. is recalling SimplyProtein peanut butter chocolate crispy bars sold at Costco due to undeclared cashew allergen. 2.46 million boxes are affected.

    Product
    SimplyProtein¿ Peanut Butter Chocolate Crispy 15-1.41 OZ (40 g) bar. (UPC 6 86207 00914 7) Sold in 15-count variety pack with two other flavors (Lemon Coconut and Chocolate Sea Salt) NET WT 21/16 OZ (600 g). Outside carton UPC 6 86207 80906 8. Packaged in a carboard box. Indiv
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1371-2023·2023-04-19

    Inflatable Penile Prosthesis Recall Due to Potential Pump Failure Risk

    Coloplast is recalling certain inflatable penile prostheses due to decreased wall thickness that may cause premature pump failure. No injuries have been reported.

    Product
    Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0723-2023·2023-04-19

    Animal Crackers in Meal Kits Recalled Due to Possible Metal Shavings

    E S Foods is recalling animal crackers in meal kits distributed nationwide because they may contain bronze metal shavings that could cause choking or internal injury if ingested.

    Product
    61151 Apple Muffin Top TSMB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1379-2023·2023-04-19

    Swan-Ganz Thermodilution Catheter May Bend and Cause Monitor Error

    Edwards Lifesciences is recalling Swan-Ganz CCOmbo V thermodilution catheters because the distal end may bend beyond its intended curvature, potentially causing the patient monitoring device to display an error message.

    Product
    Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.7mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 9F (3.0 mm)
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-1351-2023·2023-04-19

    Outset Tablo Hemodialysis System Recall Due to Software Manufacturing Defect

    Outset Medical is recalling 374 Tablo hemodialysis systems due to a software malfunction introduced during manufacturing. The defect causes frequent high conductivity dialysate alarms in devices distributed nationwide.

    Product
    Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System), intended for acute, home and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facil
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0698-2023·2023-04-19

    Zone Perfect Fudge Graham bars recalled for hard plastic fragments

    Abbott Laboratories is recalling Zone Perfect Fudge Graham bars due to potential hard plastic fragments in the product. Affected bars were distributed to 36 U.S. states.

    Product
    Zone Perfect Fudge Graham bar 50g bars packaged in foil wrapped- 12 bars individually wrapped per cardboard carton
    Category
    Food
    Distribution
    35 states
  • HighFDA (Devices)·Z-1384-2023·2023-04-19

    Knee Patella Drills Recalled for Incorrect Diameter Markings

    Encore Medical is recalling EMPOWR Knee Patella drills due to reversed diameter markings that could cause incorrect drill selection during surgery, leading to implant loosening or bone fracture.

    Product
    EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1353-2023·2023-04-19

    PET/CT Imaging System Recall: Software Issue Prevents Image Reconstruction

    Shanghai United Imaging uMI 550 PET/CT imaging system is recalled due to a software defect that may prevent scatter correction during patient scanning, potentially blocking diagnostic PET image generation.

    Product
    Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0530-2023·2023-04-19

    Pantoprazole Sodium Tablets Recalled for CGMP Deviations and Discoloration

    Hetero USA Inc. is recalling 2,352 bottles of Pantoprazole Sodium 40mg tablets due to manufacturing deviations that caused discoloration. The affected lot (PAN22542, exp. 9/2024) was distributed nationwide.

    Product
    PANTOPRAZOLE SODIUM — PANTOPRAZOLE SODIUM (PANTOPRAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1374-2023·2023-04-19

    Inflatable Penile Prosthesis Titan Recalled Coloplast Manufacturing Class II

    Coloplast Manufacturing recalls 20 units of Titan 0-Deg Scrotal inflatable penile prosthesis (Lot Numbers 8849601, 8849600, 8849621) with worldwide distribution. The specific reason for the recall is not specified in FDA records.

    Product
    Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1381-2023·2023-04-19

    NanoKnife Surgical Probes Recalled Due to RFID Programming Error

    Angiodynamics recalls NanoKnife 5-Probe Procedure Packs due to a programming error affecting RFID function. The probes may not be recognized by the NanoKnife generator, potentially delaying surgical procedures.

    Product
    NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number: 20400111 UPN: H787204001110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0716-2023·2023-04-19

    Hiland Fat Free Chocolate Milk Recalled Due to Food Grade Sanitizer Contamination

    Hiland Dairy Foods Company is recalling Hiland Fat Free Chocolate Milk Vitamin A&D sold in Texas. A small number of cartons may contain food grade sanitizer residue.

    Product
    Hiland Fat Free Chocolate Milk Vitamin A&D Naturally Flavored Half Pint (236 mL) UPC 72060 00133 4 packaged in a paper carton
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0532-2023·2023-04-19

    Prescription Drug Recall: Incorrect Expiration Date on MEKTOVI Labels

    Pfizer recalls 1,926 bottles of MEKTOVI (binimetinib) due to incorrect expiration dates on labels. Bottles labeled March 2026 actually expire February 2025.

    Product
    MEKTOVI — MEKTOVI (BINIMETINIB)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1354-2023·2023-04-19

    Thermage CPT System unit improperly tested and calibrated during manufacturing

    Solta Medical is recalling one Thermage CPT System unit that was potentially improperly tested and calibrated during manufacturing. The company is contacting the affected customer regarding corrective action.

    Product
    thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF GENERATOR REF TG-2B *** Solta Medical, Inc. Dermatologic and general surgical procedures for electrocoagulation and hemostasis; " Non-invasive treatment of periorbital wrinkles and rhytids including u
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0531-2023·2023-04-19

    Bevacizumab Injection Recall Due to Incorrect Lot Number Labeling

    Pine Pharmaceuticals is recalling 932 syringes of Bevacizumab 2.5 mg/0.1 mL due to incorrect lot number labeling on the primary packaging. The affected lot (#66377, expiration 06/28/2023) was distributed nationwide.

    Product
    Bevacizumab 2.5 mg/0.1 mL, Solution for Injection in 1mL, silicone free slip tip syringe, each Syringe supplied in individually labeled poly envelopes (primary packaging). Repackaged by Pine Pharmaceuticals, Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150, Offic
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0529-2023·2023-04-19

    Drug Injection Recall: Norepinephrine Bitartrate Impurity Above Specification

    Sun Pharmaceutical is recalling Norepinephrine Bitartrate Injection due to a chemical impurity exceeding specification limits detected during routine monitoring. The recall affects 16,450 vials distributed nationwide.

    Product
    NOREPINEPHRINE BITARTRATE — NOREPINEPHRINE BITARTRATE (NOREPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0756-2023·2023-04-19

    Magnesium Citrate Tribasic Hydrate Powder Recalled for Microbial Contamination

    Jost Chemical Co is recalling Magnesium Citrate Tribasic Hydrate powder due to elevated microbial counts above the manufacturer's specification. Lot 25350037 (3,300 pounds) was distributed to Florida.

    Product
    Magnesium Citrate Tribasic Hydrate, USP, Ultrafine Powder sold in bulk 55 lb fiber box.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0713-2023·2023-04-19

    Frisch's Tuna Salad Recalled Due to Condensation Contamination

    FKC LLC is recalling Frisch's Tuna Salad in 4-pound tubs distributed in Ohio, Kentucky, and Indiana due to condensation observed falling into the food.

    Product
    Frisch's Tuna Salad packaged in 4lb plastic tubs - sold individually
    Category
    Food
    Distribution
    3 states