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.

4951–4975 of 88106

  • HighFDA (Devices)·Z-0720-2026·2025-12-03

    Anesthesia vaporizers recalled over the potential for anesthesia leakage

    Mindray is recalling 148 Sevoflurane V90 Electronic Vaporizers used with the A9 Anesthesia System over the potential for anesthesia leakage.

    Product
    Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Sev E_Vap. (Safety Filling adapter), Part Number: 115-066756-00. 2. Exchange Sev E_Vap. (Safety Filling adapter), Part Number: E115-066756-00. Product Description…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0681-2026·2025-12-03

    IV set 490426 recalled over piggyback backflow and occlusion risk

    B. Braun Medical is recalling 63,192 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/10 DROPS…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0658-2026·2025-12-03

    IV set 470005 recalled over medication backflow and priming failure

    B. Braun Medical is recalling 29,900 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 SET 15DR 3 CARESITE…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0642-2026·2025-12-03

    IV set 490385 recalled over medication backflow between IV containers

    B. Braun Medical is recalling 168,816 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 numbers: 1. IV ADMIN SET, 10…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0674-2026·2025-12-03

    IV set 490507 recalled over backflow and inability to prime

    B. Braun Medical is recalling 48,672 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 ADMINISTRATION SET WITH…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0670-2026·2025-12-03

    IV set 352636 recalled over piggyback backflow and priming occlusion

    B. Braun Medical is recalling 20,694,734 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 15 DR W/2…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0685-2026·2025-12-03

    IV set 490312 recalled over medication backflow between IV containers

    B. Braun Medical is recalling 226,632 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 ADMN SET W/15 DROP…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0639-2026·2025-12-03

    Extension set V5405 recalled over backflow and inability to prime

    B. Braun Medical is recalling 300 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/2INJ/FLBL/FML LRLK/CV 34…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0640-2026·2025-12-03

    Universal infusion sets recalled over piggyback backflow and priming occlusion

    B. Braun Medical is recalling 49,330,370 Infusomat administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    Infusomat 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. UNIV.15DROP PUMP SET W/3 SAFELINE LL…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0661-2026·2025-12-03

    IV set 490309 recalled over backflow into the primary bag

    B. Braun Medical is recalling 259,392 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/ 2…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0703-2026·2025-12-03

    IV set 490301 recalled over backflow from secondary piggyback containers

    B. Braun Medical is recalling 31,392 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 AD.SET W/15 DR 128 IN…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0708-2026·2025-12-03

    Outlook pump sets recalled over backflow into the primary container

    B. Braun Medical is recalling 2,352 Outlook pump 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 133…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0611-2026·2025-12-03

    Anesthesia infusion sets recalled over backflow into the primary bag

    B. Braun Medical is recalling 19,392 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, 15 DROPS/ML 125…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0631-2026·2025-12-03

    Extension set 490629 recalled over backflow and priming occlusion

    B. Braun Medical is recalling 13,128 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. EXTENSION SET, 25 IN.; Catalog…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0643-2026·2025-12-03

    IV set NF1270A recalled over piggyback backflow and priming occlusion

    B. Braun Medical is recalling 13,870 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. NF1270A SAFELINE…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0613-2026·2025-12-03

    Anesthesia set 490476 recalled over piggyback backflow and priming occlusion

    B. Braun Medical is recalling 19,320 units 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, 2-HIGH FLOW…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0721-2026·2025-12-03

    Isoflurane vaporizers recalled over the potential for anesthesia leakage

    Mindray is recalling 54 Isoflurane V90 Electronic Vaporizers used with the A9 Anesthesia System over the potential for anesthesia leakage.

    Product
    Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Iso E_Vap. (Safety Filling adapter), Part Number 115-066758-00. 2. Exchange Iso E_Vap. (Safety Filling adapter), Part Number E115-066758-00. Product Description…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0709-2026·2025-12-03

    Outlook set 354212 recalled over piggyback backflow and occlusion risk

    B. Braun Medical is recalling 162,648 units 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 IV SET 15DROP W/2 CARESITE…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0697-2026·2025-12-03

    IV set 480231 recalled over backflow from secondary piggyback containers

    B. Braun Medical is recalling 85,176 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/15…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0722-2026·2025-12-03

    Hot and cold wraps recalled over microwave instructions causing burns

    DJO is recalling 1,594 Cold Form Wraps because the instructions tell users to microwave the wrap for three minutes, which may cause leaks or second degree burns.

    Product
    Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0657-2026·2025-12-03

    IV set 490427 recalled over piggyback backflow and priming occlusion

    B. Braun Medical is recalling 224,856 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/ 15…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0589-2026·2025-12-03

    Vena cava filters recalled over resistance when advancing the dilator

    Argon Medical Devices is recalling 1,821 Option ELITE Vena Cava Filter Systems after complaints of increased resistance when advancing the dilator within the introducer sheath.

    Product
    Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions: " Pulmonary…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0668-2026·2025-12-03

    IV set 490504 recalled over piggyback backflow and priming occlusion

    B. Braun Medical is recalling 36,936 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…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0677-2026·2025-12-03

    IV set 490612 recalled over medication backflow between IV containers

    B. Braun Medical is recalling 5,952 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. 15DR 2SAFELINE 1CARESITE…
    Category
    Medical Device
    Distribution
    0 states