The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

2651–2675 of 52932

  • HighFDA (Devices)·Z-0608-2026·2025-12-03

    Anesthesia IV sets recalled over backflow and inability to prime

    B. Braun Medical is recalling 14,712 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 AD. SET,15 DROPS/ML, W/EXT S
    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 W/
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0634-2026·2025-12-03

    Extension sets recalled over piggyback backflow into primary containers

    B. Braun Medical is recalling 23,650 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. EXTENSION SET W/ ULTRAPORT, 48 IN.;
    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 H.
    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-0667-2026·2025-12-03

    Infusion pump sets recalled over medication backflow and occlusion

    B. Braun Medical is recalling 37,656 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, 16
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0612-2026·2025-12-03

    Anesthesia set 490444 recalled over piggyback backflow and priming occlusion

    B. Braun Medical is recalling 88,200 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, 15D 2 CARESITE LA
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0179-2026·2025-12-03

    Saline nasal spray recalled over microbial contamination with Pseudomonas lactis

    Medical Products Laboratories is recalling 41,328 bottles of Walgreens Saline Nasal Spray with Xylitol over microbial contamination identified as Pseudomonas lactis.

    Product
    Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45mL) bottle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015, NDC 0363-3114-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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, CARESIT
    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-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, CARESIT
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0717-2026·2025-12-03

    IV set 490508 recalled over backflow into the primary container

    B. Braun Medical is recalling IV administration set catalog number 490508 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/ 15DROPS/ML;
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0588-2026·2025-12-03

    Heated massage tables recalled over heat components that can smolder

    Pivotal Health Solutions is recalling 464 Quantum Intersegmental Tables because damage to the heat function components can lead to overheating, smoldering and melting of the vinyl cushion.

    Product
    Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage table
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0630-2026·2025-12-03

    IV extension sets recalled over backflow between piggyback and primary containers

    B. Braun Medical is recalling 43,452 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. EXTENSION SET, 18 IN; Catalog Numb
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0710-2026·2025-12-03

    Rate flow sets recalled over backflow and inability to prime

    B. Braun Medical is recalling 150,664 RATE FLOW sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    RATE FLOW 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. RATEFLOW ADMIN 15 DROP W/2 CARESITE
    Category
    Medical Device
    Distribution
    0 states
  • 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 CARESIT
    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-0604-2026·2025-12-03

    ADDitIV sets recalled over backflow between primary and secondary containers

    B. Braun Medical is recalling 100 ADDitIV administration 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 number: 1. V1782F UNIV IV SET W/0.2 MICRON FILTER; C
    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 ULT
    Category
    Medical Device
    Distribution
    0 states
  • 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, SAFE
    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.; Cata
    Category
    Medical Device
    Distribution
    0 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-0694-2026·2025-12-03

    IV administration sets recalled over backflow from piggyback containers

    B. Braun Medical is recalling 2,544 IV administration sets over the potential for medication to flow back from secondary piggyback containers into primary 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 124 IN.; Catal
    Category
    Medical Device
    Distribution
    0 states