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.

19226–19250 of 50410

  • HighFDA (Devices)·Z-2456-2021·2021-09-22

    FDA recalls BD burette sets for connector valve occlusion and flow defects

    BD Gravity Burette Sets and Add-On Burette Sets are being recalled due to needle-free connector valve defects that may cause flushing difficulties, flow problems, or complete occlusions, potentially delaying therapy. The recall affects approximately 77,802 units distributed worldwide.

    Product
    BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV, REF: 10037031; BD Gravity Burette Set 20 DROP 1.2 Micron Filter 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV , REF: 10037032; BD GRAVITY BURETTE SET 60 DROP 2 Smartsite VALVES BALL DRIP…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2465-2021·2021-09-22

    BD SE Burette Set needle-free connectors recalled for flow obstruction risk

    CareFusion is recalling BD SE Burette Sets with needle-free connector valves that may fail to flush or develop flow obstructions, risking therapy delays. Approximately 56,680 units were distributed worldwide.

    Product
    BD SE Burette Set 20 Drops 2 Injection Ports Vented/NonVented, REF: 72103E-0006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0966-2021·2021-09-22

    Full Tilt Vanilla Bean Ice Cream Recall for Pasteurization Failure

    Full Tilt Ice Cream is recalling Vanilla Bean ice cream in pints and tubs because the ice cream mix did not meet pasteurization specifications, which could allow harmful bacteria to survive.

    Product
    Vanilla Bean, Full Tilt Ice Cream, packaged in 16oz pre packed pints and 3 gallon tubs. UPC on pint containers only: 00856962005283
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0963-2021·2021-09-22

    Full Tilt Mexican Chocolate Ice Cream Recall for Pasteurization Failure

    Full Tilt Ice Cream is recalling Mexican Chocolate ice cream in pints and tubs distributed in Washington because the ice cream mix did not meet pasteurization specifications.

    Product
    Mexican Chocolate, Full Tilt Ice Cream brand, packaged in 16oz pre packed pints and 3 gallon tubs. UPC on pint container only: 00856962005023.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2472-2021·2021-09-22

    Alinity ci-series System Control Module Software Performance Issues

    Abbott's Alinity ci-series analyzers with software version 3.2.3 and earlier have multiple issues that could display expired reagents as valid, fail to alert operators to errors, and produce incorrect test results.

    Product
    Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model number LN 03R70-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2482-2021·2021-09-22

    Braun ThermoScan PRO 6000 Ear Thermometer Recall: Burn Risk from Fluid Exposure

    Braun ThermoScan PRO 6000 ear thermometers may overheat if exposed to fluids and used before drying, risking burns to the user or patient. More than 1 million units are affected.

    Product
    Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body temperature for patients having ages ranging from normal weight (full term) newborn to geriatric adults in a professional use environment. Model: 6000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0967-2021·2021-09-22

    Full Tilt Ice Cream Peanut Butter Chip Recall for Pasteurization Failure

    Full Tilt Ice Cream is recalling Peanut Butter Chip ice cream in 3-gallon tubs distributed in Washington because the ice cream mix did not meet pasteurization specifications.

    Product
    Peanut Butter Chip, Full Tilt Ice Cream brand, packaged in 3 gallon tubs. No UPC.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0973-2021·2021-09-22

    Full Tilt Mint Chip Ice Cream Recall for Pasteurization Failure

    Full Tilt Ice Cream is recalling Mint Chip ice cream in 3-gallon tubs distributed in Washington because the ice cream mix did not meet pasteurization specifications.

    Product
    Mint Chip, Full Tilt Ice Cream brand, packaged in 3 gallon tubs. No UPC.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2460-2021·2021-09-22

    BD needle-free connector valves recalled for flow obstruction risk

    BD needle-free connector valves and extension sets may experience flow obstruction and flushing difficulties, potentially delaying medical therapy. No adverse events have been reported.

    Product
    BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 10010511; BD SmartSite Extension Set Needle-Free Valve, REF: 10010912; BD EXTENSION SET SMALLBORE TUBING DETACHABLE SmartSite VALVE, REF: 10010983; BD Gravity Burette Set 60 DP 4 VersaSafe PORTS 3 SmartSite VALVES BALL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0978-2021·2021-09-22

    Vita Aid SynerClear Powder Recalled for Undeclared Milk Contamination

    Naturo Aid Pharmaceutical Inc. is recalling Vita Aid SynerClear (Unflavoured) powder because it may contain undeclared milk residue. Consumers with milk allergies are at risk.

    Product
    Vita Aid SynerClear (Unflavoured), VA-925. The product is a powder, packaged in a plastic bottle and a white cap, with a net weight of 650g.
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-2443-2021·2021-09-22

    Hero Model 100 Smart Pill Dispenser Recalled for Software Dose-Prompting Error

    Hero Health is recalling the Model 100 smart pill dispenser due to a software defect causing the device to prompt users to take medication doses that have already been dispensed, creating overdose risk.

    Product
    The Hero Model 100 (H-100) is a system consisting of a smart pill dispenser and a medication management app.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0970-2021·2021-09-22

    Full Tilt Strawberry Ice Cream Recall Due to Inadequate Pasteurization

    Full Tilt Ice Cream is recalling Strawberry ice cream in 16oz pints and 3-gallon tubs because the ice cream mix did not meet pasteurization specifications. Products distributed in Washington with Julian dates of 20621X and earlier, or tub dates of 7/26/21 and earlier, are affected.

    Product
    Strawberry, Full Tilt Ice Cream brand, packaged in 16oz pre packed pints and 3 gallon tubs. UPC on pint container: 00856962005290.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2476-2021·2021-09-22

    Philips Azurion Imaging System Failure at 480V Hospital Power Supply

    Philips Azurion medical imaging devices may fail when powered by hospital electrical systems providing 480V. The failure reduces X-ray performance and may be preceded by a burning smell.

    Product
    The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: "Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0977-2021·2021-09-22

    Vita Aid Keto-Elemental Nutrition powder recalled for undeclared milk

    Naturo Aid Pharmaceutical is recalling Vita Aid Keto-Elemental Nutrition (Thai) powder because it may contain undeclared milk residue. The product was distributed across ten U.S. states.

    Product
    Vita Aid Keto-Elemental Nutrition (Thai), VA-958. The product is a powder, packaged in an aluminum bag , with a net weight of 315g.
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-2479-2021·2021-09-22

    Bariatric ceiling-mounted lift spreader bar can disconnect from scale attachment

    Arjohuntleigh recalls 62 Maxi Sky 1000 and V10 bariatric ceiling lifts because the spreader bar can disconnect from the scale attachment. Users should immediately stop using affected units and contact the manufacturer.

    Product
    Maxi Sky 1000 (Arjo) and V10 (BHM) Bariatric Ceiling Rail - Mounted Lift with measuring function
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-2470-2021·2021-09-22

    Arjo Disposable Repositioning Sling Recalled for Trip Hazard Risk

    Getinge recalled 46,085 Arjo Disposable Repositioning Sling units because the sling loop straps pose a trip hazard. The affected devices were distributed nationwide to healthcare facilities.

    Product
    Arjo Disposable Repositioning Sling, Model AHD001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2446-2021·2021-09-22

    Siemens radiation therapy software may lose treatment structure data

    Siemens syngo.CT software used in radiation therapy systems may lose treatment structure data during edit and reopen operations, sending incomplete treatment information to planning systems.

    Product
    syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SOMATOM go.Now SOMATOM go.Up SOMATOM go.All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro and SOMATOM X.cite Material Numbers: 11061620 11061628 11061630 11061640 11061660 11061670
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0962-2021·2021-09-22

    Full Tilt Ice Cream Salted Caramel Recall—Pasteurization Failure

    Full Tilt Ice Cream is recalling Salted Caramel ice cream in 16oz pints and 3-gallon tubs distributed in Washington because the ice cream mix did not meet pasteurization specifications.

    Product
    Salted Caramel, brand Full Tilt Ice Cream, packaged in 16oz pre-packed pints and 3 gallon tubs. UPC on pint container only: 00856962005009.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2449-2021·2021-09-22

    Pentax Upper GI Endoscopes and Colonoscopes: Updated Reprocessing Instructions

    Pentax Medical is updating reprocessing instructions for certain gastroscope and colonoscope models to ensure proper sterilization. Affected healthcare facilities should review and implement the updated instructions.

    Product
    Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Family # 2- Gastroscopes with a Water Jet Channel Models: EG-2990i, EG-2990K, EG-3490K, EG29-i10; Gastroscope Family # 3-Gastroscopes with Two…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2478-2021·2021-09-22

    Medtronic HVAD Pump Implants: Driveline Cover May Impede Connector Access

    Medtronic HVAD Pump Implant Kits may require increased force to remove the driveline cover after strain relief repair, potentially making controller exchanges difficult and risking further repair damage.

    Product
    Medtronic HVAD Pump Implant Kits
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2466-2021·2021-09-22

    BD Alaris Infusion Pump Buerette Set Connector Valve Occlusion Issues

    BD Alaris needle-free connector valves in Buerette Sets may develop occlusions, difficulty flushing, or flow issues that could delay patient therapy. The product was distributed worldwide across all US states and multiple countries.

    Product
    BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette) 3 SmartSite Y-Sites, REF: 2441-0006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2453-2021·2021-09-22

    Configura Advance Mobility Chairs Recalled for Potential Backrest Detachment

    Accora Inc is recalling multiple Configura Advance Chair models due to a potential defect where the backrest may detach, creating a fall risk for users.

    Product
    Configura Advance Chair, Model Number: CHAIR-0-SC1-030; Advance Chair, 100mm Castors, Std Backrest, Manual; Serial Numbers: 10001-SC1-20 to 10483-SC1-20; 10001-SC1-21 to 10224-SC1-21; 10231-SC1-21 to 10456-SC1-21; 10481-SC1-21 to 10570-SC1-21. Model Number: CHAIR-0-SC2-030…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0794-2021·2021-09-22

    Oxycodone Hydrochloride Tablets Recalled for Foreign Tablet Contamination

    Rhodes Pharmaceuticals is recalling Oxycodone Hydrochloride 10 mg tablets (Lot # WP5K0Y) distributed nationwide after a foreign Hydrochlorothiazide/Lisinopril tablet was found in one bottle.

    Product
    OXYCODONE HYDROCHLORIDE — OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0984-2021·2021-09-22

    Albanese Mini Gummi Butterflies recalled for undeclared dietary supplement

    Albanese World's Best Mini Gummi Butterflies (7.5oz) contain comingled Olly Sleep dietary supplement that may cause drowsiness. Consumers should not eat the product.

    Product
    Albanese World's Best Mini Gummi Butterflies 7.5oz UPC 634418523525
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0964-2021·2021-09-22

    Full Tilt Ice Cream Backyard Mint Chip Recall for Pasteurization Issue

    Full Tilt Ice Cream is recalling Backyard Mint Chip ice cream in 16oz pints and 3-gallon tubs because the ice cream mix did not meet pasteurization specifications. The product was distributed in Washington.

    Product
    Backyard mint chip, Full Tilt Ice Cream brand, packaged in 16oz pre packed pints and and 3 gallon tubs. UPC on pint container: 00856962005054.
    Category
    Food
    Distribution
    1 state