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.

27426–27450 of 50462

  • HighFDA (Devices)·Z-3339-2018·2018-10-10

    B. Braun Perifix FX Catheter Connectors Recalled for Leakage and Disconnection

    B. Braun Medical is recalling Perifix FX catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CE17TKFPS PERIFIX FX CONT. EPID TRAY-LF, Material Number 332087 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3334-2018·2018-10-10

    B. Braun Medical Recalls CE17TKFSA Full Tray Catheter Connectors

    B. Braun Medical is recalling CE17TKFSA full trays because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    CE17TKFSA FULL TRAY W/17G TUOHY 19G SPRW, Material Number 332080 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3350-2018·2018-10-10

    B. Braun Medical Recalls CE18T Continuous Epidural Sets

    B. Braun Medical is recalling CE18T Continuous Epidural Sets because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    CE18T CONT EPIDURAL SET, Material Number 332200 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0021-2019·2018-10-10

    Oridion CAPNOSTREAM 20P Bedside Patient Monitor Recall for Settings Reset

    Oridion Medical is recalling CAPNOSTREAM 20P bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    CAPNOSTREAM 20P (US) N, Part Number CS08651-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3403-2018·2018-10-10

    B. Braun Medical Recalls Epidural Catheter Connectors Due to Leakage Risk

    B. Braun Medical is recalling 3,050 epidural catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    EPID. CATH. NG, 20GA. CLOSED TIP-LF, Material Number 333541 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3353-2018·2018-10-10

    B. Braun Medical Recalls CE17TO Epidural Catheter Connectors

    B. Braun Medical is recalling CE17TO epidural catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CE17TO CONT EPIDURAL SET LF, Material Number 332204 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0012-2019·2018-10-10

    Baker's Service Recalls Coconut and Pineapple Pastry for Undeclared Wheat

    Baker's Service of South Florida, Inc. is recalling 58 cases of Coconut and Pineapple Pastry because the product labeling failed to declare wheat.

    Product
    Coconut and Pineapple Pastry. The product is packed in a cardboard box. The firm marks the Coconut and Pineapple Pastry option printed on the box. Labeling on the cardboard box reads in part: WHOLESALE FROZEN BAKERY PRODUCTS, TRACY BAKERY,COCONUT AND PINEAPPLE PASTRY…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-3395-2018·2018-10-10

    B. Braun Medical Recalls Catheter Connectors Due to Leakage and Disconnection

    B. Braun Medical is recalling specific catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    NES1727KFX W /17GA TUOHY 19GA SPRW OT, Material Number 333197 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0069-2019·2018-10-10

    ICU Medical Bifuse Transfer Set Recalled Due to Missing Blood Filter

    ICU Medical is recalling 2,361 Bifuse Transfer Sets because a design change removed the blood filter, creating a risk of use as a blood transfusion set.

    Product
    ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system…
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-3388-2018·2018-10-10

    B. Braun Recalls Spinal and Epidural Catheter Connectors

    B. Braun Medical is recalling 200 spinal/epidural trays because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    GOVES1827K SPINAL/EPIDURAL TRAY (LF), Material Number 332614 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3404-2018·2018-10-10

    B. Braun Recalls Pain Management Trays Due to Catheter Leakage

    B. Braun Medical is recalling Design Options Pain Management Trays because catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    DESIGN OPTIONS¿ PAIN MANAGEMENT TRAY, Material Numbers 530029, 530029, 530031, 530035, 530041, 530048, 530068, 530071, 530083, 530108, 530112, 530122, 530123, 530124, 530132, 530133, 530134, 530138, 530141, 530142, 530149, 530153, 530155, 530159, 530160, 530164, 530168, 530169…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0006-2019·2018-10-10

    Oregon Heritage Farms Apple Cider Recalled for Elevated Patulin Levels

    Oregon Heritage Farms is recalling 1-gallon containers of Family Blend Apple Cider due to elevated levels of patulin.

    Product
    Oregon Heritage Farms Family Blend Apple Cider, 100% Juice, 1 gallon plastic container, UPC: 8 53581 00202 0. The label is read in parts: "***FAMILY BLEND Apple Cider 100% Juice Not from concentrate *** Pasteurized ***Refrigerate After Opening *** Ingredients: Apple Cider…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-3393-2018·2018-10-10

    B. Braun Medical Recalls Spinal and Epidural Catheter Connectors

    B. Braun Medical is recalling ES1827KDS Spinal/Epidural Full Kits because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    ES1827KDS SPINAL/EPIDURAL FULL KIT, Material Number 333194 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3281-2018·2018-10-10

    Stryker AXS Infinity LS Long Sheath Recalled for Specification Exceedance

    Stryker Neurovascular is recalling 15 units of the AXS Infinity LS Long Sheath because the dilator's outer diameter exceeded specifications.

    Product
    AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN-10800-90) Made in Ireland, Sterile EO. The AXS Infinity LS Long Sheath system contents are: One (1) AXS Infinity LS Long Sheath, One (1) Hemostasis valve…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-3352-2018·2018-10-10

    B. Braun Recalls CE17T Continuous Epidural Sets Due to Leakage

    B. Braun Medical is recalling 504 CE17T Continuous Epidural Sets because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    CE17T CONT EPIDURAL SET, Material Number 332202 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3378-2018·2018-10-10

    B. Braun Medical Recalls 18GA Safety Tuohy Needle Trays

    B. Braun Medical is recalling 2,070 units of 18GA Safety Tuohy Needle Trays because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    CE18TKY 18GA SAFETY TUOHY NEEDLE TRAY, Material Number 332266 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3377-2018·2018-10-10

    B. Braun Medical Recalls Epidural Catheter Connectors Due to Leakage

    B. Braun Medical is recalling 1,040 epidural catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CCE18HK10L CONT EPIDURAL TRAY, Material Number 332264 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0004-2019·2018-10-10

    Varian TrueBeam and EDGE Radiotherapy Systems Recalled for Gating Anomaly

    Varian Medical Systems is recalling TrueBeam and EDGE radiotherapy systems because a software anomaly can cause treatments to occur without intended respiratory gating.

    Product
    TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3348-2018·2018-10-10

    B. Braun Catheter Connector Recall Due to Leakage and Disconnection

    B. Braun Medical is recalling CONTI CONT 4inTUOHY ULTRA 360 PNB TRAY catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CONTI CONT 4inTUOHY ULTRA 360 PNB TRAY, Material Number 332143 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0065-2019·2018-10-10

    Vision RT AlignRT Plus Integrated Gate Controller PCB Recall

    Vision RT Ltd is recalling 690 AlignRT Plus systems due to an RTInterface error that can occur during I/O communication between the Integrated Gate Controller PCB and the Framegrabber PCB.

    Product
    Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3319-2018·2018-10-10

    B. Braun Medical Recalls Contiplex Tuohy Sets Due to Leakage

    B. Braun Medical is recalling specific Contiplex Tuohy Sets because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    CONTIPLEX TUOHY SET, 18GX4", 1.3X100MM, Material Number 331693 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in…
    Category
    Medical Device
    Distribution
    Distributed nationwide