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.

7351–7375 of 26961

  • SevereFDA (Food)·F-0452-2025·2025-02-05

    Yummi Sushi salmon products recalled for possible Salmonella contamination

    GBC Food Services is recalling Yummi Sushi salmon products distributed in Texas due to possible Salmonella contamination. The recall affects products produced November 22-29, 2024.

    Product
    Spicy Salmon Roll UPC: 85375900865 Qty: 1 Tray, Net Wt: 8.1oz (230g) 11/22 to 11/29/2024 Fusion Spring Roll (Salmon) UPC: 85375900891 Qty: 1 Tray, Net Wt: 7.2oz (204g) 11/22 to 11/29/2024 Grilled Salmon Roll UPC: 85694200877 Qty: 1 Tray, Net Wt: 10oz (284g) 11/22 to 11/29/2024 Se
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0448-2025·2025-02-05

    Multiple Sushi Products Recalled for Possible Salmonella Contamination

    GBC Food Services is recalling multiple Yummi Sushi varieties due to possible Salmonella contamination. The affected products were distributed in Texas and have best-by dates of 11/30/2024.

    Product
    Multiple varieties of sushi: Cheetos¿ Flamin' Hot¿ California Roll UPC: 85005520995 Net Wt: 10.1 oz (286g) 11/22 to 11/29/2024 Spicy Crunchy Yummi Roll UPC: 85375900882 Qty: 1 Tray, Net Wt: 11oz (312g) 11/22 to 11/29/2024 Tornado Roll UPC: 85375900885 Qty: 1 Tray, Net Wt: 11oz (
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0445-2025·2025-02-05

    Vegetable Ranch Tray recalled for potential Salmonella contamination

    Vegetable Ranch Tray products from Yummi Sushi may contain Salmonella. Consumers who purchased items between November 22-29, 2024 should not eat them and should discard or return them.

    Product
    Vegetable Ranch Tray No Dip Small 850054894335 19.5 oz (553g)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0431-2025·2025-02-05

    Frozen peach mango sorbet recalled for undeclared egg allergen

    The Mochi Ice Cream Company is recalling My Mochi Sorbet Peach Mango Sorbet nationwide due to undeclared egg allergen. Consumers with egg allergies should not consume this product.

    Product
    My Mochi Sorbet Peach Mango Sorbet; Keep Frozen; 6 pieces per container; 6-1.25 OZ (35g) PIECES NET WT 7.5 OZ (210g)*** Nutritional Panel: 6 servings per container; JOYFULLY CHILL!; Made in a nut-free facility; Made by My/Mochi, 5563 Alcoa Ave., Los Angeles, CA 90058; www.mymochi
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0453-2025·2025-02-05

    Yummi Sushi Bao Buns and Gyoza Recalled for Possible Salmonella Contamination

    Yummi Sushi is recalling Karaage Chicken Bao Buns and Gyoza Combo products due to possible Salmonella contamination. The affected products were distributed in Texas with a best-by date of 11/30/2024.

    Product
    Karaage Chicken Bao Buns UPC: 85006499045 Net Wt: 8.8 oz (251g) 11/22 to 11/29/2024 Gyoza Combo UPC: 85001442018 Qty: 11 pcs, Net Wt: 13.3 OZ (377g) 11/22 to 11/29/2024
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0210-2025·2025-02-05

    FDA Class I Recall: Astagraf XL Immunosuppressant Capsules May Be Empty

    Astellas Pharma is recalling Astagraf XL (tacrolimus) due to manufacturing defects; bottles shipped nationwide may contain empty capsules instead of medication.

    Product
    ASTAGRAF XL — ASTAGRAF XL (TACROLIMUS EXTENDED-RELEASE CAPSULES)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0439-2025·2025-02-05

    Salad Recall: Southwest Salad from Yummi Sushi Due to Salmonella Risk

    GBC Food Services is recalling Southwest Salad products (6,088 units) distributed in Colorado due to potential Salmonella contamination. Products purchased between November 22-29, 2024 may be affected.

    Product
    Southwest Salad 850065403069 Net Wt: 4oz (113g)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0446-2025·2025-02-05

    Vegetable Bowls Recalled Due to Potential Salmonella Contamination

    GBC Food Services is recalling 6,088 vegetable bowls due to potential Salmonella contamination. The affected products were purchased between November 22-29, 2024, and distributed in Colorado.

    Product
    Vegetable Bowl 860010507131 26 oz (738g)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0450-2025·2025-02-05

    Sushi Products Recalled for Possible Salmonella Contamination

    GBC Food Services dba Yummi Sushi is recalling multiple prepared sushi products distributed in Texas due to possible Salmonella contamination. Products with code dates 11/22–11/29/2024 should not be consumed.

    Product
    Spicy Tuna with Spicy Mayo Roll UPC: 85375900839 Qty: 1 Tray, Net Wt: 7.8oz (223g) 11/22 to 11/29/2024 Spicy Tuna with Spicy Mayo Roll UPC: 85006061926 Qty: 1 Tray, Net Wt: 7.8oz (223g) 11/22 to 11/29/2024. Tuna Tataki Poke Bowl UPC: 85004566863 Net Wt: 14.5oz (412g) 11/22 to 11/
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0430-2025·2025-02-05

    Tzatziki Sauce Recalled Due to Potential Salmonella Contamination

    Corfu and Mediterranean brand tzatziki sauce in half-gallon tubs and 5-gallon pails are being recalled for potential Salmonella contamination. Consumers should not eat the affected products.

    Product
    Corfu Tzatziki sauce packaged in half gallon plastic tubs, 4 tubs per case. Mediterranean Tzatziki sauce packaged in half gallon plastic tubs, 4 tubs per case. Unbranded Tzatziki sauce packaged in half gallon plastic containers, 4 tubs per case. Corfu Tzatziki sauce packaged in 5
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Devices)·Z-0992-2025·2025-02-05

    Medline General Surgery Arterial Line Tray kits recalled for manufacturing defect

    Medline arterial line tray kits (models ART600 and ART690) are being recalled because the catheter hub contains excess material from manufacturing. The recall affects 58 kits distributed nationwide.

    Product
    Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0455-2025·2025-02-05

    Alpha Test supplement capsules recalled for unapproved cathine ingredient

    Iovate Health Sciences is recalling Alpha Test 120-count capsules containing cathine, an unapproved ingredient not permitted in dietary supplements. Affected products were distributed across the United States and internationally.

    Product
    Alpha Test 120 count Black labeled plastic bottle, 12 bottles per case of 120 count capsules each per bottle, Store in a cool, dry place (60 F to 80 F), UPC 6-31656-60676-8, SKU0001191, SKU0002075
    Category
    Drug
    Distribution
    30 states
  • HighFDA (Devices)·Z-1066-2025·2025-02-05

    Infinity Central Station speakers may fail to produce critical patient alarms

    Edifier speakers in Draeger's Infinity Central Station may not produce audible alarms when in analog mode, potentially delaying patient treatment. Approximately 1,013 units are affected worldwide.

    Product
    Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of dat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1041-2025·2025-02-05

    Medline procedure kits recalled for surgical masks failing sterilization tests

    Medline SHORT TERM INFUSAPORT ACCESS KIT with reorder number DYNDC3188 is recalled because included surgical masks failed bioburden testing, potentially compromising sterility during procedures.

    Product
    Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT, Reorder number DYNDC3188; surgery tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0433-2025·2025-02-05

    LuLu Chinese Express frozen shrimp meal lacks soy allergen labeling

    LuLu Chinese Express Sweet and Sour Shrimp with Fried Rice is being recalled because soy allergen information is missing from the label. Consumers with soy allergies face a serious health risk.

    Product
    LuLu Chinese Express, Sweet and Sour Shrimp w/ Fried Rice, Net Wt. 16 oz (1 lb), UPC 2393329006, packaged in plastic container.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1040-2025·2025-02-05

    Medline Procedure Kits Recalled for Surgical Mask Bioburden Testing Failure

    Medline has recalled 749 procedure kits containing surgical masks that failed to meet bioburden testing standards under EN 14683. The affected kits were distributed nationwide.

    Product
    Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130; 2) VANTEX 7FR 3L 20CM CVC STOCK+ BUNDLE US. Reorder number STCVC01USGV; general surgical tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1061-2025·2025-02-05

    Karl Storz Ureteroscope recalled nationwide for unapproved reprocessing instructions

    Karl Storz Ureteroscope model 27000K is being recalled due to instructions for use containing reprocessing modalities not reviewed or approved by the FDA. The recall affects 82 units distributed nationwide.

    Product
    KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1039-2025·2025-02-05

    Knee Implant Component Recalled for Incorrect Metal Post Assembly

    Zimmer, Inc. is recalling 155 units of NexGen LCCK Legacy knee implant components because the metal support post was assembled incorrectly in some units. The defective assembly could compromise implant function.

    Product
    NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1026-2025·2025-02-05

    AXIOS stent delivery system outer sheath detachment prevents proper expansion

    Boston Scientific recalls 1,399 units of AXIOS stent delivery systems due to outer sheath detachment that can prevent proper device expansion, requiring procedure prolongation and device exchange.

    Product
    AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1035-2025·2025-02-05

    Stent system outer sheath may detach, preventing proper expansion

    Boston Scientific's HOT AXIOS Stent has a reported defect where the outer sheath distal black tip can detach, preventing proper stent expansion and requiring device exchange.

    Product
    HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1033-2025·2025-02-05

    HOT AXIOS Stent Delivery System Outer Sheath May Detach, Preventing Stent Expansion

    Boston Scientific's HOT AXIOS stent delivery system has a defect where the outer sheath can detach and prevent proper stent expansion, requiring device replacement.

    Product
    HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1054-2025·2025-02-05

    Karl Storz Pediatric Uretero-Renoscope Recalled for Unapproved Reprocessing Instructions

    Karl Storz Endoscopy is recalling its Pediatric Uretero-Renoscope 7.3 Fr. due to unapproved reprocessing instructions. The device instructions contain procedures not reviewed or approved by the FDA for safety and efficacy.

    Product
    KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0457-2025·2025-02-05

    Mustard Products Recalled Due to Salmonella in Seeds

    Keith Valley and Red Boy brand mustards distributed in the South and Southwest are being recalled because mustard seeds tested positive for Salmonella. Consumers should not consume affected products.

    Product
    Keith Valley mustard, net 1 gal, Distributed by: Ben E Keith Food Ft Worth, TX, UPC 046045062467; Red Boy brand mustard, Net 1 GAL., Distributed by Clements Food Company Oklahoma City, OK 73116, UPC 071735128154
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0436-2025·2025-02-05

    FDA Recalls Cucumber Bowl with Ranch Dip Due to Salmonella Risk

    GBC Food Services is recalling Cucumber Bowls with Ranch dip purchased between November 22-29, 2024, due to potential Salmonella contamination. The recall affects 6,088 units distributed in Colorado.

    Product
    Cucumber Bowl with Ranch dip 850054894519 15oz (425g)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1021-2025·2025-02-05

    Design Options Combined Spinal/Epidural Tray Recalled for Connector Defect

    B. Braun Medical is recalling 1,090 units of the Design Options Combined Spinal/Epidural Tray due to an incorrect catheter connector that cannot securely connect to the epidural catheter, preventing medication administration.

    Product
    Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal space and epidural space for pain control. Model/Catalog Number: 530159
    Category
    Medical Device
    Distribution
    Distributed nationwide