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.

4976–5000 of 88106

  • HighFDA (Devices)·Z-0673-2026·2025-12-03

    IV set 490522 recalled over backflow from secondary piggyback containers

    B. Braun Medical is recalling 41,016 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-0691-2026·2025-12-03

    IV set 490408 recalled over backflow between primary and secondary containers

    B. Braun Medical is recalling 24,072 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, 2 CARESITES…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·H-0208-2026·2025-12-03

    Cinnamon powder recalled after lead measured at 2.92 milligrams per kilogram

    Homeneeds is recalling 7 cases of DEVI brand Cinnamon Powder after an FDA sample of the ground cinnamon was found to contain 2.92 mg/kg of lead.

    Product
    DEVI brand Cinnamon Powder (Dalchini Powder), net wt.: 3.5 oz (100 g), packaged in flexible plastic bag. UPC 6 09595 11904 5. Imported and Distributed by Homeneeds Inc. Bellevue, WA 98007; Product of India
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0622-2026·2025-12-03

    Burette set 490159 recalled over backflow into the primary container

    B. Braun Medical is recalling 7,240 burette sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    Burette 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. BURETTE SET W/ 2 CARESITE, 134 IN.…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0695-2026·2025-12-03

    IV set 490193 recalled over backflow and inability to prime

    B. Braun Medical is recalling 111,312 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 HF 4-WAY…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0713-2026·2025-12-03

    SAFELINE set 352604 recalled over backflow from secondary containers

    B. Braun Medical is recalling 46,250 SAFELINE sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    SAFELINE 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. UNIVERSAL IV ADMIN SET; Catalog…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0700-2026·2025-12-03

    IV set 490088 recalled over medication backflow and priming failure

    B. Braun Medical is recalling iv administration sets, catalog number 490088, 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. NF1505, IV ADMIN SET W/2…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0653-2026·2025-12-03

    IV set 490329 recalled over backflow and inability to prime

    B. Braun Medical is recalling 18,984 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, 81 IN W/ 32…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0650-2026·2025-12-03

    IV set 490317 recalled over backflow and occlusion risk

    B. Braun Medical is recalling 6,650 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 CARESITE 127 IN.…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0629-2026·2025-12-03

    Extension set 456520 recalled over backflow and priming occlusion

    B. Braun Medical is recalling 2,100 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. ANES SET W/DUAL FEM.LL SAFEPORT…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0583-2026·2025-12-03

    Skin cancer aid recalled because it may not meet specifications

    DermaSensor is recalling nine affected units of its software-aided diagnostic device because it may not meet specifications, risking incorrect results or a delayed referral.

    Product
    DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0609-2026·2025-12-03

    Anesthesia set 490477 recalled over backflow and inability to prime

    B. Braun Medical is recalling 36,552 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 W/15 DROPS/ML…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0683-2026·2025-12-03

    IV set 354211 recalled over piggyback backflow and occlusion risk

    B. Braun Medical is recalling 286,400 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 ADM 15 DROP W/3…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0696-2026·2025-12-03

    IV set 490437 recalled over piggyback backflow and occlusion risk

    B. Braun Medical is recalling 4,536 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-0617-2026·2025-12-03

    Blood set 490355 recalled over backflow into the primary container

    B. Braun Medical is recalling 24,624 units 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/ 170…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0660-2026·2025-12-03

    IV set 490343 recalled over piggyback backflow and priming occlusion

    B. Braun Medical is recalling 1,272 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,2 CARESITE…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0655-2026·2025-12-03

    IV set 457504 recalled over medication backflow and priming failure

    B. Braun Medical is recalling 80,650 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 W/2 CARESITE & 2…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0707-2026·2025-12-03

    Outlook set 354213 recalled over backflow into the primary container

    B. Braun Medical is recalling 18,072 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/3 CARESITE…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0625-2026·2025-12-03

    Caresite set 354202 recalled over backflow and inability to prime

    B. Braun Medical is recalling 2,871,707 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-0602-2026·2025-12-03

    Respiratory test panels recalled over elevated risk of false negative results

    BioFire Diagnostics is recalling 23 kits of the BioFire Respiratory Panel 2.1 because unintended movement of pouch chemistry may cause false negative results and control failures.

    Product
    BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0662-2026·2025-12-03

    IV set 490367 recalled over medication backflow and priming failure

    B. Braun Medical is recalling 6,768 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/60 DR/ML…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0723-2026·2025-12-03

    Imaging software recalled over a bug that can lose clinical information

    Intelerad Medical Systems is recalling 19 IntelePACS InteleConnect and TechPortal installations because a bug can cause data loss in the Relevant Clinical Info field.

    Product
    IntelePACS - InteleConnect / TechPortal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0606-2026·2025-12-03

    Anesthesia set 490189 recalled over piggyback backflow and occlusion risk

    B. Braun Medical is recalling 32,436 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 W/15 DROPS/ML…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0185-2026·2025-12-03

    Tea tree balm recalled over current good manufacturing practice deviations

    CA Botana International is recalling 555 tubes of Doctor D. Schwab Controlling Balm with Tea Tree Oil for CGMP deviations.

    Product
    Doctor D. Schwab Controlling Balm with Tea Tree Oil, Salicyclic Acid 0.8%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92123. NDC: 35192-016-05
    Category
    Drug
    Distribution
    5 states