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.

4901–4925 of 88106

  • HighFDA (Devices)·Z-0652-2026·2025-12-03

    IV set 490241 recalled over backflow and inability to prime

    B. Braun Medical is recalling 66,792 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET HF…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0714-2026·2025-12-03

    ULTRASITE set 352049-C recalled over backflow and inability to prime

    B. Braun Medical is recalling 41,400 ULTRASITE sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    ULTRASITE set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 2 ULTRASITE VLV…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0664-2026·2025-12-03

    IV set 490315 recalled over backflow between primary and secondary containers

    B. Braun Medical is recalling 11,832 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 15 DR/ML,2…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0715-2026·2025-12-03

    Vista set US9923F recalled over piggyback backflow and priming occlusion

    B. Braun Medical is recalling 74,652 Vista Basic sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    Vista set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. VISTA BASIC PUMP IV SET W/ 15 DROP/ML…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0599-2026·2025-12-03

    Myriad handpieces recalled because packaging tape contains undisclosed latex

    Stryker is recalling 39,148 NICO Myriad Handpieces because tape used to secure components in the packaging contains latex despite the products being labelled latex-free.

    Product
    NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13 MHP; NN-8002 15x 25 MHP - MINOP; NN-8003 13x10 MHP; NN-8004 13x13 MHP; NN-8005 15x25 MHP GAAB; NN-8006 11X10 MHP; NN-8007 11x13 MHP; NN-8008 19x28 MHP OI; NN-8010…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0624-2026·2025-12-03

    Caresite set 354204 recalled over piggyback backflow and priming occlusion

    B. Braun Medical is recalling 12,225,913 units caresite sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog numbers: 1. Primary Gravity IV Set with 2…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0594-2026·2025-12-03

    Diabetes clinic software recalled over incorrect sensor glucose graph data

    Medtronic MiniMed is recalling 12,126 CareLink Clinic installations because a software error displays incorrect data on the 24-hour sensor glucose overview graph.

    Product
    CareLink Clinic, REF: MMT-7350
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0665-2026·2025-12-03

    IV set 490489 recalled over piggyback backflow and inability to prime

    B. Braun Medical is recalling 3,120 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 15DR, 92 IN…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0645-2026·2025-12-03

    IV set 490067 recalled over medication backflow between IV containers

    B. Braun Medical is recalling 407,800 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV SET 15DR 5CARESITE 1…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0598-2026·2025-12-03

    Anesthesia set 490469 recalled over backflow and priming occlusion

    B. Braun Medical is recalling 104,784 units anesthesia iv sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy SystemTM and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedure.
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Food)·H-0207-2026·2025-12-03

    Ice cream bars recalled over undeclared wheat and soy allergens

    Jeni's Splendid Ice Creams is recalling 3,767 cases of Passion Fruit Dreamsicle Ice Cream Bars over undeclared wheat and soy.

    Product
    Jeni's Passion Fruit Dreamsicle Ice Cream Bars, 3 FL OZ (89 ML)/9 FL OZ (266 ML), packaged 3 bars per retail carton with Item UPC: 850060644122, packed 8 retail cartons per case with Case UPC: 10850060644129
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-0706-2026·2025-12-03

    Outlook infusion sets recalled over backflow and inability to prime

    B. Braun Medical is recalling 6,672 Outlook sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. OUTLOOK PUMP SET,3 CARESITE LADS,115…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0616-2026·2025-12-03

    Blood set 490196 recalled over piggyback backflow and priming occlusion

    B. Braun Medical is recalling 7,344 blood administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. Y-TYPE BLOOD SET 124…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0663-2026·2025-12-03

    IV set 490400 recalled over backflow and inability to prime

    B. Braun Medical is recalling 19,104 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/CARESITE…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0647-2026·2025-12-03

    Single lot IV sets recalled over backflow and priming occlusion

    B. Braun Medical is recalling 48 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN 15D, 2 B/C VLV, 3…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0580-2026·2025-12-03

    Expandable spinal cages recalled because they may lose height or collapse

    Medtronic Sofamor Danek is recalling 275,260 Catalyft PL and PL40 expandable interbody spacers because the cage may lose height or collapse, risking migration or neurological injury.

    Product
    Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT PL SHORT 7MM. Model Number: 6068073. 2. SPACER 6068076 CATALYFT PL LONG 7MM, Model Number: 6068076. 3. SPACER 6068093 CATALYFT PL SHORT 9MM…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0693-2026·2025-12-03

    Standard IV sets recalled over medication backflow from piggyback containers

    B. Braun Medical is recalling 41,976 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0626-2026·2025-12-03

    Caresite set 354207 recalled over backflow and priming occlusion

    B. Braun Medical is recalling 381,850 Caresite primary gravity sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. Primary Gravity Filtered Set with 2…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0607-2026·2025-12-03

    IV set 477002 recalled over backflow from secondary piggyback containers

    B. Braun Medical is recalling 22,928 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0690-2026·2025-12-03

    IV set 490303 recalled over piggyback backflow and occlusion risk

    B. Braun Medical is recalling 32,304 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET,3 CARESITE…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0620-2026·2025-12-03

    Blood set 480233 recalled over backflow from piggyback containers

    B. Braun Medical is recalling 5,448 blood administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. Y-TYPE BLOOD SET W…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0600-2026·2025-12-03

    Illumination packs recalled because packaging tape contains undisclosed latex

    Stryker is recalling 39,148 NICO Myriad Illumination Packs because tape used to secure components in the packaging contains latex despite the products being labelled latex-free.

    Product
    NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g Illumination Sleeve/Fiber
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0618-2026·2025-12-03

    Blood set 490530 recalled over backflow and inability to prime

    B. Braun Medical is recalling 33,528 blood administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. Y-TYPE BLOOD SET, 3…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0644-2026·2025-12-03

    IV set 352394 recalled over backflow between primary and secondary containers

    B. Braun Medical is recalling 1,250 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. US1295 ULTRASITE IV ADMIN…
    Category
    Medical Device
    Distribution
    0 states