The Recall Desk

Archive

October 2018 recalls

865 recalls were announced in October 2018.

What the numbers show

Critical
24
Severe
129
High
473
Moderate
213
Low
26

Of the 865 recalls this month scored against our rubric, 3% are Critical, 15% are Severe.

Which agencies issued them

601–700 of 865

  • HighFDA (Devices)·Z-3401-2018·2018-10-10

    B. Braun Recalls EC20CS Epidural Catheter Connectors Due to Leakage

    B. Braun Medical is recalling EC20CS Epidural Catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    EC20CS EPIDURAL CATHETER, Material Number 333532 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-3331-2018·2018-10-10

    B. Braun Medical Recalls Epidural Basic Trays Due to Connector Leakage

    B. Braun Medical is recalling CE17TBFC Epidural Basic Trays because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    CE17TBFC EPIDURAL BASIC TRAY 17G TOUHY, Material Number 332077 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-3282-2018·2018-10-10

    Rayner C-flex Intraocular Lens Recall Due to Refractive Errors

    Rayner Intraocular Lenses Limited is recalling 49 C-flex 570C +19.0D intraocular lenses distributed in Missouri due to reports of post-operative refractive errors.

    Product
    C-flex 570C +19.0D Intraocular Lens Product Usage: C-flex IOLs are designed to be surgically implanted into the capsular bag of the human eye as a replacement for the crystalline lens following phacoemulsification
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0014-2019·2018-10-10

    Baker's Service Recalls Coconut & Cheese Pastry for Undeclared Wheat

    Baker's Service of South Florida, Inc. is recalling 28 cases of Coconut & Cheese Pastry because the finished product labeling failed to declare wheat.

    Product
    Coconut & Cheese Pastry. The product is packed in a cardboard box. The firm marks the Coconut& Cheese Pastry option printed on the box. Labeling on the cardboard box reads in part: WHOLESALE FROZEN BAKERY PRODUCTS, TRACY BAKERY,COCONUT & CHEESE PASTRY, HANDLING INSTRUCTIONS…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0010-2019·2018-10-10

    Baker's Service of South Florida Recalls Cheese Pastry for Undeclared Wheat

    Baker's Service of South Florida, Inc. is recalling 706 cases of Cheese Pastry because the product labeling failed to declare wheat as an ingredient.

    Product
    Cheese Pastry. The product is packed in a cardboard box. The firm marks the Cheese Pastry option printed on the box. Labeling on the cardboard box reads in part: WHOLESALE FROZEN BAKERY PRODUCTS, TRACY BAKERY, CHEESE PASTRY, HANDLING INSTRUCTIONS, PREPARATION & BAKING…
    Category
    Food
    Distribution
    0 states
  • 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
  • HighFDA (Devices)·Z-3383-2018·2018-10-10

    B. Braun Medical Recalls Epid Paed Full Kit Catheter Connectors

    B. Braun Medical is recalling 610 units of Epid Paed Full Kit catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    EPID PAED FULL KIT 24GA CT NG CATH LF, Material Number 332292 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-0066-2019·2018-10-10

    OptiMedica Catalys Precision Laser System Recalled for Software Alignment Failures

    Johnson & Johnson is recalling nine Catalys Precision Laser Systems because a software upgrade causes alignment verification cuts to mismatch the intended treatment overlay.

    Product
    OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial Numbers: 44109015; 44106215; 44107315; and 44065613 label states "Manufactured for: OptiMedica Corporation 1310 Moffett Park Drive Sunnyvale, CA 94089 USA Product…
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-3382-2018·2018-10-10

    B. Braun Recalls Pediatric Epidural Catheter Connectors Due to Leakage

    B. Braun Medical is recalling 1,380 pediatric epidural catheter connectors because they may not stay closed, causing leakage or disconnection.

    Product
    CEP18TKO CONT. EPIDURAL PEDIATRIC KIT, Material Number 332290 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-3376-2018·2018-10-10

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

    B. Braun Medical is recalling 4,150 epidural catheter connectors because they may not stay closed, causing leakage or disconnection.

    Product
    CE17TK19CDP CONT EPIDURAL TRAY, Material Number 332262 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-3389-2018·2018-10-10

    B. Braun Medical Recalls Spinal and Epidural Catheter Connectors

    B. Braun Medical is recalling ES1725K Spinal/Epidural Trays because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    ES1725K SPINAL/EPIDURAL TRAY, Material Number 333165 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-3370-2018·2018-10-10

    B. Braun Medical Recalls CE17TKPS Continuous Epidural Anesthesia Trays

    B. Braun Medical is recalling CE17TKPS Continuous Epidural Anesthesia Trays because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    CE17TKPS CONTINUOUS EPIDURAL ANES TRAY, Material Number 332233 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-0049-2019·2018-10-10

    Oridion Capnostream20 N Monitors Recalled for Settings Reset Issue

    Oridion Medical is recalling five Capnostream20 N bedside monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 N W/PRINTER CYVITAL, CS08798
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3385-2018·2018-10-10

    B. Braun Accu-Bloc Perifix Kit Recalled for Catheter Leakage

    B. Braun Medical is recalling 1,380 Accu-Bloc Perifix Kits because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    GOVCE18TK ACCU-BLOC PERIFIX KIT, Material Number 332600 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-3392-2018·2018-10-10

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

    B. Braun Medical is recalling 1,490 Espocan Spinal/Epid Trays because the catheter connectors may not stay closed, causing leakage or disconnection.

    Product
    ESPOCAN SPINAL/EPID TRAY W/ 18G TUOHY, Material Number 333193 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-0001-2019·2018-10-10

    Smith & Nephew Recalls Journey BCS Knee CoCr Femoral Components

    Smith & Nephew is recalling Journey BCS Knee CoCr Femoral Components because registry data indicates the first-generation system has a revision rate over 1.5 times the class average.

    Product
    Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3354-2018·2018-10-10

    B. Braun Medical Recalls CE18HKCD Epidural Tray Connectors

    B. Braun Medical is recalling CE18HKCD epidural tray connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CE18HKCD CONT EPIDURAL TRAY, Material Number 332206 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-3313-2018·2018-10-10

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

    B. Braun Medical is recalling 600 CONTI TUOHY ULTRA 360 catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CONTI TUOHY ULTRA 360 2 IN CONT PNB SET, Material Number 331640 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-3360-2018·2018-10-10

    B. Braun Medical Recalls 18GA Tuohy Catheter Connectors for Leakage

    B. Braun Medical is recalling 18GA Tuohy catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CE18TKCD10L 18GA TUOHY/10CC GLAS, Material Number 332217 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-3391-2018·2018-10-10

    B. Braun Recalls Spinal and Epidural Catheter Connectors Due to Leakage

    B. Braun Medical is recalling ES1827K Spinal/Epidural Trays because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    ES1827K SPINAL/EPIDURAL TRAY (LF), Material Number 333192 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-3349-2018·2018-10-10

    B. Braun Catheter Connectors Recalled for Leakage and Disconnection

    B. Braun Medical is recalling 1,350 CNB400TU3KUE catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CNB400TU3KUE 18GX4 CONTI THY ULTRA 360, Material Number 332170 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-0020-2019·2018-10-10

    Oridion CAPNOSTREAM 20 Patient Monitors Recalled for Settings Reset

    Oridion Medical is recalling 3,143 CAPNOSTREAM 20 patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    CAPNOSTREAM 20 (US) N, Part Number CS08651
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3343-2018·2018-10-10

    B. Braun Medical Recalls Epidural Catheter Connectors Due to Leakage

    B. Braun Medical is recalling 93,140 epidural catheter connectors because they may not stay closed, causing leakage or disconnection.

    Product
    CE17TKFCS CONT EPID TRAY W/17G TUOHY-LF, Material Number 332097 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-3371-2018·2018-10-10

    B. Braun Perifix FX Continuous Epidural Set Recalled for Connector Leakage

    B. Braun Medical is recalling 1,032 Perifix FX Continuous Epidural Sets because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    CE17TF PERIFIX FX CONTIN. EPIDURAL SET, Material Number 332234 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-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
  • HighFDA (Devices)·Z-3372-2018·2018-10-10

    B. Braun Medical Recalls CE17TOD Epidural Tray Connectors

    B. Braun Medical is recalling CE17TOD epidural tray connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CE17TOD CONT EPIDURAL TRAY LF, Material Number 332235 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-0014-2019·2018-10-10

    Kerlix Bandage Rolls Recalled for Potential Sterility Breach

    COVIDIEN LLC is recalling Kerlix Bandage Rolls due to a seal defect that may compromise sterility. The recall covers 2,730,821 units distributed nationwide.

    Product
    Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 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-3341-2018·2018-10-10

    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
    CE17TKFSDTD EPID TRAY W/17GA FIXED WING, Material Number 332095 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
  • ModerateFDA (Devices)·Z-0059-2019·2018-10-10

    Ortho VITROS FSH Reagent Pack Recalled for Potential Biased Results

    Ortho Clinical Diagnostics is recalling VITROS FSH Reagent Packs because biotin supplements may cause biased test results at lower concentrations than indicated.

    Product
    VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0040-2019·2018-10-10

    Oridion Medical CAPNOSTREAM 20 Bedside Monitors Recalled for Settings Reset

    Oridion Medical is recalling 144 CAPNOSTREAM 20 bedside monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    CAPNOSTREAM 20 (INTL) N W/PRINTER, Part Number CS08658
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0036-2019·2018-10-10

    Oridion CapnoStream 20 Bedside Patient Monitor Recall for Settings Reset

    Oridion Medical is recalling 245 CapnoStream 20 bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    CAPNOSTREAM 20 (INTL) N, Part Number CS08652
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0058-2019·2018-10-10

    Ortho VITROS Folate Reagent Pack Recall for Biotin Interference

    Ortho Clinical Diagnostics is recalling VITROS Folate Reagent Packs because biotin supplements may cause biased test results at lower concentrations than stated.

    Product
    VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0034-2019·2018-10-10

    Oridion Capnostream20 Monitors Recalled for Settings Reset Issue

    Oridion Medical is recalling 48 refurbished Capnostream20 monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (US) N W/PRINTER REFURBISHED, Part Number CS78657
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0024-2019·2018-10-10

    Oridion CAPNOSTREAM 20 Patient Monitors Recalled for Settings Reset

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

    Product
    CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0061-2019·2018-10-10

    Ortho VITROS TSH Reagent Packs Recalled for Potential Biotin Interference

    Ortho Clinical Diagnostics is recalling VITROS TSH Reagent Packs because biotin supplements may cause biased test results at lower concentrations than stated in the instructions.

    Product
    VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0046-2019·2018-10-10

    Oridion Capnostream20 M NICU Monitors Recalled for Settings Reset

    Oridion Medical is recalling 262 Capnostream20 M NICU monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 M NICU (CPM), CS08654RN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0028-2019·2018-10-10

    Oridion Capnostream20 Bedside Patient Monitors Recalled for Settings Reset

    Oridion Medical is recalling 769 Capnostream20 bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (US) M, Part Number CS08653
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0022-2019·2018-10-10

    Oridion Medical CAPNOSTREAM 20P 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 - ROHS, Part Number CS08651-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0006-2019·2018-10-10

    Sichuan Friendly Pharmaceutical Recalls Thyroid Powder Due to CGMP Deviations

    Sichuan Friendly Pharmaceutical Co., Ltd. is recalling Thyroid Powder 25kg/drum because the product has inconsistent levels of active ingredients.

    Product
    Thyroid Powder 25kg/drum, US Pharmacopoeia, Sichuan Friendly Pharmaceutical Co., LTD, Production Address: No. 680, Hongpai Road, Dongxing District, Neijiang City Sichuan, China Tel:+886 832 2240082/2240298. NDC 7807-0170-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0033-2019·2018-10-10

    Oridion Capnostream20 Monitors Recalled for Settings Reset Issue

    Oridion Medical is recalling 43 refurbished Capnostream20 monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (US)M REFURBISHED, Part Number CS78653
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0032-2019·2018-10-10

    Oridion Capnostream20 Monitors Recalled for Settings Reset Issue

    Oridion Medical is recalling 46 Capnostream20 bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (US) N REFURBISHED, Part Number CS78651
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0030-2019·2018-10-10

    Oridion Capnostream20 Monitors Recalled for Settings Reset Issue

    Oridion Medical is recalling Capnostream20 bedside monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (US) M TO MASIMO, Part Number CS08750
    Category
    Medical Device
    Distribution
    Distributed nationwide

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