The Recall Desk

Archive

October 2018 recalls

865 recalls were announced in October 2018.

What the numbers show

Critical
24
Severe
111
High
490
Moderate
214
Low
26

Of the 865 recalls this month scored against our rubric, 3% are Critical, 13% are Severe.

501–600 of 865

  • SevereUSDA FSIS·089-2018·2018-10-11

    Jerky Boyz Recalls Chicken Jerky Due to Possible Underprocessing

    Jerky Boyz Chicken Jerky is recalling approximately 23 pounds of ready-to-eat chicken jerky products due to a processing deviation that may have led to underprocessing.

    Product
    Jerky Boyz Chicken Jerky Recalls Chicken Jerky Products due to Possible Processing Deviation
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·18V710000·2018-10-11

    Toyota Recalls 2019 C-HR Vehicles Due to Rear Axle Bolt Issues

    Toyota is recalling 2019 C-HR vehicles because rear axle hub bearing bolts may be insufficiently tightened. This defect could damage brake components or cause a rear wheel to detach, increasing crash risk.

    Product
    TOYOTA — TOYOTA C-HR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V712000·2018-10-11

    Erwin Hymer Recalls 2018-2019 Motorhomes Due to Generator Overcharging

    Erwin Hymer is recalling 172 motorhomes because the generator may overcharge auxiliary batteries, potentially causing acid spills if non-sealed batteries are used.

    Product
    ROADTREK — ROADTREK, HYMER, CARADO SIMPLICITY SRT, AKTIV 2.0, AKTIV, BANFF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·090-2018·2018-10-11

    Valley Fine Foods Recalls Meat and Poultry Products Due to Spoilage

    Valley Fine Foods is recalling approximately 35,516 pounds of heat-treated meat and poultry products that may be adulterated with spoilage organisms.

    Product
    Valley Fine Foods Recalls Meat and Poultry Products due to Possible Adulteration
    Category
    Food
    Distribution
    6 states
  • LowNHTSA·18V711000·2018-10-11

    Toyota Recalls 2018-2019 Tundra for Incorrect Load Capacity Label

    Toyota is recalling 2018-2019 Tundra vehicles because the load carrying capacity label incorrectly overstates weight by 10 pounds, failing federal safety standards.

    Product
    TOYOTA — TOYOTA TUNDRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·088-2018·2018-10-10

    Malone's Fine Sausage Recalls Pork Head Cheese Due to Listeria

    Malone's Fine Sausage is recalling pork head cheese products potentially contaminated with Listeria monocytogenes. The products were sold in Illinois, Michigan, and Wisconsin.

    Product
    Malone's Fine Sausage, Inc. — Malone's Fine Sausage, Inc. Recalls Pork Head Cheese Products due to Possible Listeria Contamination
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0064-2019·2018-10-10

    Leica HistoCore SPECTRA ST Slide Stainer Recalled for Electrical Safety Hazard

    Leica Microsystems is recalling 67 automated slide stainers because a single fault could expose users to hazardous mains voltage.

    Product
    Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated Product Usage: The intended use of this device is a stainer for laboratory applications and intended for the preparation of histological and cytological specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E095000·2018-10-10

    Alpha Technology Ignition Switch Recall Due to Engine Stall Risk

    Alpha Technology is recalling mechanical key ignition switches that may shift out of the RUN position, causing the engine to turn off and increasing crash risk.

    Product
    ELECTRICAL SYSTEM:IGNITION:SWITCH recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3375-2018·2018-10-10

    B. Braun Medical Recalls Epidural Catheter Connectors Due to Leakage

    B. Braun Medical is recalling 1,980 epidural catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CE17TB19C CONT EPIDURAL TRAY, Material Number 332242 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
  • SevereFDA (Devices)·Z-3381-2018·2018-10-10

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

    B. Braun Medical is recalling 6,850 clamp-style catheter connectors because they may not stay closed, causing leakage or disconnection.

    Product
    CLAMP STYLE CATH. CONNECTOR 18-19 GA- LF, Material Number 332285 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 conjunct
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0005-2019·2018-10-10

    Pfizer Recalls Elelyso Vials Due to Sterility Assurance Concerns

    Pfizer is recalling 12,416 vials of Elelyso (taliglucerase alfa) because loose metal ferrule crimps may compromise sterility.

    Product
    ELELYSO — ELELYSO (TALIGLUCERASE ALFA)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V697000·2018-10-10

    Daimler Recalls 2018-2019 Freightliner Trucks for Engine Ground Stud Defect

    Daimler Trucks North America is recalling 2018-2019 Freightliner MT45G and MT55G vehicles because an improperly tightened engine ground stud may cause overheating and increase the risk of fire.

    Product
    FCCC — FCCC MT55G, MT45G
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3364-2018·2018-10-10

    B. Braun Medical Recalls CE18TB Epidural Trays Due to Leakage

    B. Braun Medical is recalling CE18TB epidural trays because the catheter connectors may not stay closed, causing leakage or disconnection.

    Product
    CE18TB CONT EPIDURAL TRAY, Material Number 332222 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 ca
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1991-2018·2018-10-10

    Neighbors LLC Recalls Gluten-Free Cookie Dough for Undeclared Almonds

    Neighbors LLC is recalling 7,264 units of Crazy About Cookies Gluten Free Chocolate Chip Cookie Dough because the packaging fails to declare almonds as an ingredient.

    Product
    Crazy About Cookies***GLUTEN FREE CHOCOLATE CHIP COOKIE DOUGH**Net Wt. 2 lbs. (907.18g)**Nutrition facts***Ingredients: Whole grain sorghum flour, cane sugar, semi sweet chocolates**Contains eggs, milk and soy.***Manufactured in the same equipment that manufactures peanut, walnut
    Category
    Food
    Distribution
    40 states
  • SevereFDA (Devices)·Z-3321-2018·2018-10-10

    B. Braun Medical Recalls Contiplex Tuohy Sets Due to Leakage

    B. Braun Medical is recalling 1,848 Contiplex Tuohy Sets because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    CONTIPLEX TUOHY SET, 18GX11/2X 1,3X40MM, Material Number 331695 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 conjuncti
    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 conjunctio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0006-2019·2018-10-10

    Endologix AFX Endovascular AAA System Recall for Type III Endoleaks

    Endologix is notifying physicians of surveillance recommendations for the AFX Endovascular AAA System due to observed Type III endoleaks.

    Product
    ENDOLOGIX AFX Endovascular AAA System, Stent Graft System, Rx Only, Sterile EO, REF: BA22-120/I20-40, BA22-100/I20-40, BA22-80/I20-40, BA22-60/I20-40, BA22-40/I20-40, BA22-120/I16-40, BA22-100/I16-40,
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0007-2019·2018-10-10

    Endologix AFX2 Bifurcated Endograft System Recall for Type III Endoleaks

    Endologix is notifying physicians about the AFX2 Bifurcated Endograft System due to observed Type III endoleaks. This is a follow-up to a December 2016 notification.

    Product
    ENDOLOGIX AFX2 Bifurcated Endograft System, Stent Graft System, Rx Only, Sterile EO, REF: BEA22-120/I20-40, BEA22-100/I20-40, BEA22-80/I20-40, BEA22-60/I20-40, BEA22-40/I20-40, BEA22-120/I16-40, BEA22-100/I16-40, BEA22-80/I16-40,
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0008-2019·2018-10-10

    Endologix AFX Endograft Recall for Type III Endoleak Surveillance

    Endologix is notifying physicians of updated surveillance recommendations for AFX endografts due to observed Type III endoleaks.

    Product
    ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft, Rx Only, Sterile EO, AFX Proximal Accessory, Infrarenal Model #/REF: A22-22/C55, A22-22/C75, A22-22/C95, A25-25/C55, A25-25/C75, A25-25/C95, A28-28/C55, A28-28/C75, A2
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0009-2019·2018-10-10

    Endologix AFX Limb Extension Endograft Recall for Type III Endoleaks

    Endologix is notifying physicians of surveillance recommendations for AFX Limb Extension Endografts due to observed Type III endoleaks.

    Product
    ENDOLOGIX AFX/AFX2, Limb (Iliac) Extension Endograft, Rx Only, Sterile EO, AFX Limb Accessory Model #/REF: I16-16/C55, I16-16/C55F, I16-16/C88, I20-13/C70F, I20-13/C88F, I16-16/C55, I16-16/C55F, I16-16/C88, I20-13/C70F, I20-13/C88F; AFX
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Food)·F-0020-2019·2018-10-10

    Meijer Taco Seasoning Mix Recalled for Undeclared Milk

    McCormick is recalling Meijer Taco Seasoning Mix because it contains undeclared milk. The product was distributed to six Midwestern states.

    Product
    Meijer Taco Seasoning Mix, Net wt. 4.5 oz.
    Category
    Food
    Distribution
    6 states
  • HighCPSC·19007·2018-10-10

    Briggs & Stratton Recalls Generator Fuel Caps Due to Fire Hazard

    Briggs & Stratton is recalling specific fuel tank replacement caps for portable generators because they lack ventilation holes, creating a fire hazard.

    Product
    Fuel tank replacement caps made by Kelch/Bemis
    Category
    Consumer Product
    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, 7402313
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 conjunction
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3402-2018·2018-10-10

    B. Braun Medical Recalls EC20C Catheter Connectors Due to Leakage

    B. Braun Medical is recalling EC20C catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    EC20C 20G X 100CM CATH CLOSED, Material Number 333540 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 th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0016-2019·2018-10-10

    Kerlix Bandage Roll Recalled for Potential Sterility Breach

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

    Product
    Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 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 (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, P
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0002-2019·2018-10-10

    Murry's Hash Brown Potato Patties Recalled for Plastic Fragments

    Lamb Weston Inc. is recalling Murry's Hash Brown Potato Patties because they may contain small fragments of hard, clear plastic.

    Product
    Murry's Hash Brown Potato Patties, packaged in cardboard trays covered with plastic film, frozen products. -Tray UPC 0 73744 04001 4, retail packaged in 40.5 OZ (2.53 LB) (1.14 kg). -Case item M06, case UPC 1 00 73744 04001 1, case net wt. 30.375 LBS. (13.8 kg) ***Packed
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-3340-2018·2018-10-10

    B. Braun Medical Recalls Epidural Catheter Connectors Due to Leakage

    B. Braun Medical is recalling 2,420 epidural catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CE17TKFSDT EPID TRAY W/17GA FIXED WING, Material Number 332093 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 conjunctio
    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 w
    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, 5
    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 ***P
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0008-2019·2018-10-10

    Baker's Service Recalls Guava & Cheese Pastry for Undeclared Allergens

    Baker's Service of South Florida, Inc. is recalling 975 cases of Guava & Cheese Pastry because the packaging failed to declare wheat and specific color additives.

    Product
    Guava & Cheese Pastry. The product is packed in a cardboard box. The firm marks the Guava & Cheese Pastry option printed on the box. Labeling for the cardboard box reads in part: WHOLESALE FROZEN BAKERY PRODUCTS, TRACY BAKERY, GUAVA & CHEESE PASTRY, HANDLING INSTRUCTIONS, PREP
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0064-2019·2018-10-10

    Bounty Foods Recalls Deep Pit Seasoning for Undeclared Wheat and Milk

    Bounty Foods, Inc. is recalling 60 jars of Deep Pit Seasoning due to undeclared wheat and milk. The product was distributed in Montana.

    Product
    Deep Pit Seasoning, net wt. 6 oz., packaged in a clear, wide mouth jar, black and white label with black lid. The product label is read in parts: "***Deep-pit Seasoning *** Ingredients: (Hydrolyzed vegetable & soy protein, lactose, salt, partially hydrogenated cottonseed & soy
    Category
    Food
    Distribution
    1 state
  • 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, 7402113
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3369-2018·2018-10-10

    B. Braun Medical Recalls CE18HKPS Continuous Epidural Trays

    B. Braun Medical is recalling CE18HKPS Continuous Epidural Trays because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    CE18HKPS CONTIN. EPIDURAL TRAY, Material Number 332231 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 t
    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 La
    Category
    Medical Device
    Distribution
    5 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 c
    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 cath
    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 (Food)·F-0007-2019·2018-10-10

    Baker's Service Recalls Guava Pastry for Undeclared Wheat and Color Additives

    Baker's Service of South Florida is recalling 975 cases of Guava Pastry because the labeling failed to declare wheat and specific color additives.

    Product
    Guava Pastry. The product is packed in a cardboard box. The firm marks the Guava Pastry option printed on the box. Labeling for the cardboard box reads in part: WHOLESALE FROZEN BAKERY PRODUCTS, TRACY BAKERY, GUAVA PASTRY, HANDLING INSTRUCTIONS, PREPARATION & BAKING, INGREDIE
    Category
    Food
    Distribution
    0 states
  • 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, HANDLING
    Category
    Food
    Distribution
    0 states
  • 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-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 w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0070-2019·2018-10-10

    Coviden EEA Circular Stapler Recalled for Potential Tissue Gap Defect

    Coviden is recalling 1,902 EEA Circular Staplers with Tri-Staple Technology due to a potential defect that may cause incomplete staple formation or device retention in tissue.

    Product
    EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0011-2019·2018-10-10

    Ellex iScience Recalls Canaloplasty Microcatheter Kits Due to Sterility Failure

    Ellex iScience is recalling 90 units of the iTRACK 250A Canaloplasty Microcatheter Kit because a sterility failure was found in one unit of the lot.

    Product
    ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
    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-3398-2018·2018-10-10

    B. Braun Medical Recalls EC19OF Springwound 19G Epidural Catheter Connectors

    B. Braun Medical is recalling EC19OF Springwound 19G epidural catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    EC19OF SPRINGWOUND 19G EPID CATHETER, Material Number 333514 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-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 th
    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 conjunction
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0017-2019·2018-10-10

    COVIDIEN Dermacea Gauze Fluff Roll Recalled for Sterility Breach Risk

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

    Product
    Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 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-3342-2018·2018-10-10

    B. Braun Medical Recalls 17 GA Epidural Catheter Connectors

    B. Braun Medical is recalling specific epidural catheter connectors that may not stay closed, leading to potential leakage or disconnection.

    Product
    CE17TKFMHDT 17 GA X 4 FULL EPID KIT, Material Number 332096 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 w
    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 with
    Category
    Medical Device
    Distribution
    6 states
  • 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 w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3329-2018·2018-10-10

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

    B. Braun Medical is recalling 590 CONTI ECHO CT catheter connector sets because they may not stay closed, leading to leakage or disconnection.

    Product
    CONTI ECHO CT W/2IN TUOHY ULTRA 360 SET, Material Number 331767 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 conjuncti
    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 th
    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 conjunct
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3326-2018·2018-10-10

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

    B. Braun Medical is recalling 120 catheter connector kits because they may not stay closed, leading to leakage or disconnection.

    Product
    CONT STIM BASIC KIT W/2 IN INSUL TUOHY, Material Number 331757 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 conjunctio
    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-3351-2018·2018-10-10

    B. Braun Medical Recalls CE18TIN Epidural Set Connectors

    B. Braun Medical is recalling 372 CE18TIN epidural set connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CE18TIN CONT EPIDURAL SET LF, Material Number 332201 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-0019-2019·2018-10-10

    Leica HistoCore SPECTRA CV Coverslipper Recalled for Electrical Shock Risk

    Leica Microsystems is recalling one HistoCore SPECTRA CV Coverslipper unit in Missouri due to a misplaced hose that creates an electrical shock hazard.

    Product
    Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for medical diagnostics.
    Category
    Medical Device
    Distribution
    1 state
  • 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 conjunction
    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 the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0063-2019·2018-10-10

    Hemotherm 400CE Recalled for Control Panel Switch Errors

    Cincinnati Sub-Zero is recalling 270 Hemotherm 400CE devices due to potential control panel switch errors that may prevent setting changes or cause unintended changes.

    Product
    Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator/Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass pr
    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 conjuncti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3322-2018·2018-10-10

    B. Braun Medical Recalls Contiplex Insulated Tuohy Needle Connectors

    B. Braun Medical is recalling 144 units of CNB200S Contiplex Insulated Tuohy Needle connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CNB200S CONTIPLEX INSULATED TUOHY NDL, Material Number 331697 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-3368-2018·2018-10-10

    B. Braun Accu-Bloc Perifix Kit Recall for Catheter Connector Defects

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

    Product
    CE18HK ACCU-BLOC PERIFIX KIT, Material Number 332230 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-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-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 conjunctio
    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 conjunction
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0011-2019·2018-10-10

    Baker's Service Recalls Apple Pastry for Undeclared Wheat Allergen

    Baker's Service of South Florida, Inc. is recalling Apple Pastry because the labeling failed to declare wheat, a major food allergen.

    Product
    Apple Pastry. The product is packed in a cardboard box. The firm marks the Apple Pastry option printed on the box. Labeling on the cardboard box reads in part: WHOLESALE FROZEN BAKERY PRODUCTS, TRACY BAKERY, APPLE PASTRY, HANDLING INSTRUCTIONS, PREPARATION & BAKING, INGREDIENT
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0013-2019·2018-10-10

    Kerlix AMD Antimicrobial Bandage Roll Recalled for Sterility Breach Risk

    Coviden LLC is recalling Kerlix AMD Antimicrobial Bandage Rolls due to a potential seal defect that could compromise product sterility.

    Product
    Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3357-2018·2018-10-10

    B. Braun Medical Recalls Epidural Catheter Connectors Due to Leakage

    B. Braun Medical is recalling CE17TKCDLS epidural trays because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    CE17TKCDLS CONT EPIDURAL TRAY, Material Number 332212 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 th
    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 conjunction
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3405-2018·2018-10-10

    B. Braun Recalls Nonsterile Perifix Catheter Connectors Due to Leakage Risk

    B. Braun Medical is recalling 60,000 nonsterile Perifix catheter connectors because they may not stay closed, causing leakage or disconnection.

    Product
    BULK NONSTERILE PERIFIX CATHETER CONN., Material Number 8451699N 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 conjunct
    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-0038-2019·2018-10-10

    Oridion Medical CAPNOSTREAM 20P Bedside Patient Monitor Recall

    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 (INTL) N - ROHS, Part Number CS08652-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3363-2018·2018-10-10

    B. Braun Medical Recalls CE17TK Epidural Catheter Connectors

    B. Braun Medical is recalling 2,790 CE17TK epidural catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CE17TK CONT EPIDURALTUOHY, Material Number 332221 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 ca
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3336-2018·2018-10-10

    B. Braun Medical Recalls CE17TKST Epidural Catheter Connectors

    B. Braun Medical is recalling CE17TKST epidural catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CE17TKST CONT EPID W/SOFT TIP, Material Number 332082 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 th
    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 with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3330-2018·2018-10-10

    B. Braun Medical Recalls 17GA Safety Tuohy Needle Trays

    B. Braun Medical is recalling 17GA Safety Tuohy Needle Trays because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    CE17TKFCY 17GA SAFETY TUOHY NEEDLE TRAY, Material Number 332075 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 conjuncti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3333-2018·2018-10-10

    B. Braun Recalls Epidural Trays Due to Catheter Connector Leakage

    B. Braun Medical is recalling CE17TKFC Epidural Trays because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    CE17TKFC EPIDURAL TRAY W/ 17GA TUOHY, Material Number 332079 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 (Food)·F-0013-2019·2018-10-10

    Baker's Service Recalls Coconut Pastry for Undeclared Wheat

    Baker's Service of South Florida, Inc. is recalling 344 cases of Coconut Pastry because the finished product labeling failed to declare wheat.

    Product
    Coconut Pastry. The product is packed in a cardboard box. The firm marks the Coconut Pastry option printed on the box. Labeling on the cardboard box reads in part: WHOLESALE FROZEN BAKERY PRODUCTS, TRACY BAKERY,COCONUT PASTRY, HANDLING INSTRUCTIONS, PREPARATION & BAKING, INGRE
    Category
    Food
    Distribution
    0 states

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