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.

4926–4950 of 88106

  • HighFDA (Devices)·Z-0678-2026·2025-12-03

    IV set 490542 recalled over backflow between primary and secondary containers

    B. Braun Medical is recalling 7,008 units 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 15D, 2…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0632-2026·2025-12-03

    Short extension sets recalled over piggyback backflow and occlusion

    B. Braun Medical is recalling 13,600 extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    Extension 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. EXT SET W/ B/C VLV, ULTRAPORT, 57…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0582-2026·2025-12-03

    Demonstration only gel recalled because it may be placed in patients

    Straumann USA is recalling 61 units of Emdogain because product intended for demonstration purposes only could be placed in patients.

    Product
    Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0627-2026·2025-12-03

    Extension set 473309 recalled over backflow and inability to prime

    B. Braun Medical is recalling 11,650 extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    Extension 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. AS152V2DLL; Catalog Number…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0628-2026·2025-12-03

    Smallbore extension sets recalled over backflow and inability to prime

    B. Braun Medical is recalling 30,250 extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    Extension 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. ET08US EXTENSION SET W/ULTRA Y…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0702-2026·2025-12-03

    IV set 354208 recalled over medication backflow and priming failure

    B. Braun Medical is recalling 126,050 units 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…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0587-2026·2025-12-03

    Q400 massage tables recalled over heat components that can overheat

    Pivotal Health Solutions is recalling 34 Quantum Intersegmental Tables, model Q400, because damage to the heat function components can lead to overheating and smoldering.

    Product
    Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0684-2026·2025-12-03

    Anesthesia set 490472 recalled over piggyback backflow and occlusion risk

    B. Braun Medical is recalling 10,536 units anesthesia iv 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 ADM 15D 2 CARESITE…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0679-2026·2025-12-03

    IV set 490025 recalled over backflow into the primary container

    B. Braun Medical is recalling 15,250 units 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. PB1500 15 DROP IV SET W/2…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0638-2026·2025-12-03

    Caresite extension sets recalled over piggyback backflow and occlusion

    B. Braun Medical is recalling 32,500 Caresite extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    Extension 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. Caresite Extension Set_Export…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0614-2026·2025-12-03

    Anesthesia set 490468 recalled over backflow and inability to prime

    B. Braun Medical is recalling 58,752 anesthesia IV 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 117 IN.; Catalog…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0578-2026·2025-12-03

    IV set 490487 recalled over piggyback backflow and occlusion risk

    B. Braun Medical is recalling 23,160 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0654-2026·2025-12-03

    IV set 354210 recalled over backflow and inability to prime

    B. Braun Medical is recalling 1,861,111 units 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 ANES 15DROP W/2…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0688-2026·2025-12-03

    IV set 470179 recalled over backflow into the primary bag

    B. Braun Medical is recalling 28,344 units 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/ B/C…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0637-2026·2025-12-03

    Extension set 456521 recalled over backflow and priming occlusion

    B. Braun Medical is recalling 61,423 units extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    Extension 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 numbers: 1. ANESTHESIA SET W/ SAFEPORT…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0687-2026·2025-12-03

    IV set 490407 recalled over medication backflow between IV containers

    B. Braun Medical is recalling 10,896 units 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-0699-2026·2025-12-03

    IV set 490239 recalled over medication backflow between IV containers

    B. Braun Medical is recalling 5,100 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 103 IN.…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0636-2026·2025-12-03

    Extension set 490238 recalled over piggyback backflow and occlusion risk

    B. Braun Medical is recalling 11,800 units extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    Extension 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. EXT SET W/ 6 B/C VALVES, 17 IN…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0603-2026·2025-12-03

    Primary gravity sets recalled over backflow from secondary containers

    B. Braun Medical is recalling 43,900 ADDitIV primary gravity sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    ADDitIV 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, 2…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0610-2026·2025-12-03

    Extension set 490358 recalled over backflow into the primary container

    B. Braun Medical is recalling 1,200 units extension 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, 15D, 144 IN.…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0635-2026·2025-12-03

    Extension set 490234 recalled over piggyback backflow and occlusion risk

    B. Braun Medical is recalling 27,480 extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    Extension 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. EXT SET ULTRAPORT STOPCOCK, 37IN.…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0675-2026·2025-12-03

    Pump IV sets recalled over backflow from piggyback into primary bags

    B. Braun Medical is recalling 65,232 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. Catalog Number: 490549…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0718-2026·2025-12-03

    IV set 490566 recalled over backflow from secondary piggyback containers

    B. Braun Medical is recalling iv administration set catalog number 490566 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, 110 IN.…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0623-2026·2025-12-03

    CARESAFE set 354302 recalled over backflow and inability to prime

    B. Braun Medical is recalling 4,438 CARESAFE sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    CARESAFE 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. CARESAFE IV ADMIN SET w/AIRSTOP, 104…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0633-2026·2025-12-03

    IV set 490283 recalled over backflow between primary and secondary containers

    B. Braun Medical is recalling 65,904 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    Extension 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. EXTENSION SET W/ B/C VALVE 53 in.…
    Category
    Medical Device
    Distribution
    0 states