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.

27476–27500 of 50462

  • HighFDA (Devices)·Z-0005-2019·2018-10-10

    Varian VitalBeam Radiotherapy Systems Recalled for Gating Anomaly

    Varian Medical Systems is recalling VitalBeam Radiotherapy Delivery Systems due to a software anomaly that may result in treatment without intended respiratory gating.

    Product
    VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3397-2018·2018-10-10

    B. Braun Medical Recalls EC19CF Catheter Connectors Due to Leakage

    B. Braun Medical is recalling EC19CF catheter connectors because they may not stay closed, causing leakage or disconnection.

    Product
    EC19CF 19G X 100CM CATH CLOSED TIP LF, Material Number 333512 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-3365-2018·2018-10-10

    B. Braun Medical Recalls CE18HB Epidural Catheter Connectors

    B. Braun Medical is recalling CE18HB epidural catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CE18HB CONT EPIDURAL HUSTEAD, Material Number 332223 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-3289-2018·2018-10-10

    Olympus Recalls Bronchovideoscope BF-240 Due to Port Loosening Risk

    Olympus is recalling 1,467 Bronchovideoscope BF-240 units because attaching non-Olympus accessories may loosen the instrument channel port.

    Product
    Bronchovideoscope BF-240
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0023-2019·2018-10-10

    Oridion CAPNOSTREAM 20P Patient Monitor Recall for Settings Reset

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

    Product
    CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3359-2018·2018-10-10

    B. Braun Medical Recalls CE18TKPS Epidural Catheter Connectors

    B. Braun Medical is recalling CE18TKPS epidural catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CE18TKPS CONT EPIDURAL TRAY (LF), Material Number 332216 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-3394-2018·2018-10-10

    B. Braun Medical Recalls Espocan Spinal/Epidural Trays Due to Leakage

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

    Product
    ES1725KFX ESPOCAN SPINAL/EPID. TRAY, Material Number 333196 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-0015-2019·2018-10-10

    Kerlix Gauze Rolls Recalled for Potential Sterility Breach

    COVIDIEN LLC is recalling Kerlix Gauze Rolls due to a potential seal defect that could compromise sterility.

    Product
    Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3374-2018·2018-10-10

    B. Braun Medical Recalls CE17TFC Continuous Epidural Sets

    B. Braun Medical is recalling CE17TFC Continuous Epidural Sets because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    CE17TFC CONTINUOUS EPID SET W/17G TUOHY, Material Number 332238 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-0002-2019·2018-10-10

    Smith & Nephew Recalls Journey BCS Oxinium Knee Femoral Components

    Smith & Nephew is recalling Journey BCS Oxinium knee femoral components due to elevated revision rates reported in international joint registries.

    Product
    JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3347-2018·2018-10-10

    B. Braun Medical Recalls CONTIPLEX CONT 4 IN TUOHY ULTRA PNB Trays

    B. Braun Medical is recalling 340 units of CONTIPLEX CONT 4 IN TUOHY ULTRA PNB trays because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    CONTIPLEX CONT 4 IN TUOHY ULTRA PNB TRAY, Material Number 332129 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-3320-2018·2018-10-10

    B. Braun Recalls Contiplex Tuohy Sets Due to Leakage and Disconnection

    B. Braun Medical is recalling 864 Contiplex Tuohy Sets because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    CONTIPLEX TUOHY SET, 18GX6", 1.3X150MM, Material Number 331694 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-3386-2018·2018-10-10

    B. Braun Recalls Epidural Trays Due to Catheter Connector Leakage

    B. Braun Medical is recalling 1,020 epidural trays because catheter connectors may not stay closed, causing leakage or disconnection.

    Product
    GOVCE17TKFC EPIDURAL TRAY W/ 17GA TUOHY, Material Number 332602 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-3396-2018·2018-10-10

    B. Braun EC19C Catheter Connectors Recalled for Leakage and Disconnection

    B. Braun Medical is recalling EC19C catheter connectors because they may not stay closed, leading to leakage or disconnection during use.

    Product
    EC19C 19G X 100CM CATHETER CLOSED, Material Number 333511 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-3346-2018·2018-10-10

    B. Braun Medical Recalls Non-Stim Catheter Full Kits Due to Leakage

    B. Braun Medical is recalling 2,740 CNB400TKU Non-Stim Catheter Full Kits because the connectors may not stay closed, leading to leakage or disconnection.

    Product
    CNB400TKU NON-STIM CATH FULL KIT, Material Number 332128 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-0003-2019·2018-10-10

    Smith & Nephew Recalls JOURNEY BCS Knee Polyethylene Inserts

    Smith & Nephew is recalling JOURNEY BCS Knee Conventional Polyethylene Inserts due to elevated revision rates reported in international joint registries.

    Product
    JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 74023127, 74023128, 74023131, 74023132, 74023133, 74023134, 74023135, 74023136…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3323-2018·2018-10-10

    B. Braun Medical Recalls Contiplex Cont Nerve Block Catheter Connectors

    B. Braun Medical is recalling specific lots of Contiplex Cont Nerve Block catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CNB200TK CONTIPLEX CONT NERVE BLOCK, Material Number 331701 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-3324-2018·2018-10-10

    B. Braun Contiplex Cont Nerve Block Catheter Connectors Recalled for Leakage

    B. Braun Medical is recalling 4,510 units of CNB400TK Contiplex Cont Nerve Block catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CNB400TK CONTIPLEX CONT NERVE BLOCK, Material Number 331706 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-0067-2019·2018-10-10

    Heartware HVAD System Controllers Recalled for Potential Water Ingress

    Heartware, Inc. is recalling HVAD System Controllers because they may develop hairline cracks at the power ports, potentially failing to meet standards for protection against water or fluid ingress.

    Product
    Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403, 1407, and 1420 Product Usage: The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3366-2018·2018-10-10

    B. Braun Medical Recalls CE17TB Epidural Tuohy Connectors Due to Leakage

    B. Braun Medical is recalling 12,930 CE17TB Epidural Tuohy connectors because they may not stay closed, causing leakage or disconnection.

    Product
    CE17TB CONT EPIDURAL TUOHY, Material Number 332224 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