The Recall Desk

Archive

April 2014 recalls

645 recalls were announced in April 2014.

What the numbers show

Critical
60
Severe
167
High
236
Moderate
162
Low
20

Of the 645 recalls this month scored against our rubric, 9% are Critical, 26% are Severe.

501–600 of 645

  • SevereFDA (Devices)·Z-1308-2014·2014-04-09

    RaySearch Ray Station 4.0 software recalled for dose calculation errors

    RaySearch Laboratories is recalling Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy.

    Product
    RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
    Category
    Medical Device
    Distribution
    7 states
  • SevereNHTSA·14V179000·2014-04-09

    Winnebago Recalls 2014-2015 Motorhomes for Brake Hose Defect

    Winnebago is recalling specific 2014-2015 motorhomes because a manufacturing defect may have damaged brake hoses, potentially causing fluid leakage and reduced braking performance.

    Product
    WINNEBAGO — WINNEBAGO TRAVATO, ITASCA VIVA, TREND
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1705-2014·2014-04-09

    Mrs. Griffin's Barbecue Sauce Recalled for Undeclared Milk Allergen

    Bar-Jim Inc. is recalling Mrs. Griffin's Hickory Smoke Barbecue Sauce because it contains undeclared milk, a major food allergen.

    Product
    Mrs. Griffin's Hickory Smoke Barbecue Sauce, Net 32 Fl.oz. (946 mL), Made by Griffin Barbecue Sauce, Inc., Macon GA 31206
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1722-2014·2014-04-09

    Roos Foods Recalls Santa Rosa de Lima Cheese Due to Listeria

    Roos Foods is recalling Santa Rosa de Lima cheese products after samples tested positive for Listeria monocytogenes. The recall includes all brands, lots, and sizes from the facility.

    Product
    Santa Rosa de Lima Mantequilla de Bolsa Tradicion Centroamericana, 15 oz., packaged in a plastic bag, Manufactured by Roos Foods, Inc., UPC code 095548002159. (Ingredients: Cream, milk, water, salt, nonfat dry milk, cultured skim powder, gelatin, stabilizers (carrageean gum…
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-1723-2014·2014-04-09

    Roos Foods Recalls La Chapina Cream Due to Listeria Contamination

    Roos Foods Inc is recalling La Chapina Crema Guatemalteca because samples of a related cheese product tested positive for Listeria monocytogenes.

    Product
    La Chapina Crema Guatemalteca Guatemalan Style Cream, 16 oz. packaged in a plastic bag, Distribuido por: Roos Foods Distributors, 645 Lofstrand Lane, Rockville, MD 20850, UPC code 095548000414. (Ingredients: Cream, milk, water, salt, nonfat dry milk, cultured skim milk powder…
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-1721-2014·2014-04-09

    Roos Foods Recalls Amigo Brand Sour Cream Due to Listeria Contamination

    Roos Foods is recalling Amigo Brand Crema Centroamericana Cultured Sour Cream because Listeria monocytogenes was found in samples of cheese from the same facility.

    Product
    Amigo Brand Crema Centroamericana Cultured Sour Cream, Grade A, 16 oz., packed in a plastic jar, Roos Foods, Inc., Kenton, DE 19955, Plant No. 10-5436, UPC code 09554800079. (Ingredients: Cream, milk, salt, nonfat dry milk, skim milk powder, gelatin, stabilizers (carrageean…
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-1311-2014·2014-04-09

    Zoll Medical Defibrillators Recalled for Continuous Device Reset Loop

    Zoll Medical is recalling 3,169 defibrillator/pacemaker/monitor units because they may latch in a continuous reset loop, rendering them unusable.

    Product
    Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher, automated external defibrillator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1325-2014·2014-04-09

    Teleflex Recalls Weck Vista Optical Bladeless Laparoscopic Access Ports

    Teleflex Medical is recalling 55,521 Weck Vista Optical Bladeless Laparoscopic Access Ports due to complaints of insufflation gas leakage.

    Product
    5/10 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 405910R; 5/10/12 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 405912R. An endoscope and accessories is a device used to provide access, illumination, and allow observation or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1324-2014·2014-04-09

    Teleflex Medical Recalls Weck Vista Cannulas Due to Gas Leakage

    Teleflex Medical is recalling 55,521 units of 10mm and 12mm Weck Vista Cannulas because they may leak insufflation gas.

    Product
    10mm Weck Vista Cannula-only, Catalog No. 405910C, 12mm Weck Vista Cannula-only, Catalog No. 405912C. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1309-2014·2014-04-09

    Siemens Artis Zee Angiographic Systems Recalled for Cable Connection Defect

    Siemens Medical Solutions is recalling nine Artis Zee Angiographic x-ray systems due to an inappropriate cable connection that may cause system failure and restricted gantry maneuverability.

    Product
    Artis Zee Angiographic x-ray systems.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1329-2014·2014-04-09

    Ethicon Proceed Surgical Mesh Recalled for Potential Sterility Compromise

    Ethicon is recalling 223 units of Proceed Surgical Mesh due to a possible incomplete packaging seal that may have compromised sterility and caused delamination.

    Product
    Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & Johnson Medical GmbH, used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1326-2014·2014-04-09

    Teleflex Medical Recalls Weck Vista Universal Cannulas Due to Gas Leakage

    Teleflex Medical is recalling 55,521 Weck Vista Universal Cannulas because they may leak insufflation gas during use.

    Product
    5/10 mm Weck Vista Universal Cannula, Catalog No. 405910RC; 5/10/12 mm Weck Vista Universal Cannula, Catalog No. 405912RC. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1327-2014·2014-04-09

    Teleflex Medical Recalls Weck Vista Universal Cone Open Access Devices

    Teleflex Medical is recalling 55,521 Weck Vista Universal Cone Open Access devices due to complaints of insufflation gas leakage.

    Product
    5/10/12 mm x 100mm Weck Vista Universal Cone Open Access, Catalog No. 405933. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1322-2014·2014-04-09

    Elekta Integrity Software Recalled for Incorrect Radiation Beam Delivery Tolerances

    Elekta, Inc. is recalling Integrity 1.1 software because it uses static calibration tolerances instead of calculated values for radiation delivery.

    Product
    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1319-2014·2014-04-09

    Merit Medical Pressure Monitoring Tubing Recalled for Sterilization Failure

    Merit Medical Systems is recalling 80 units of Pressure Monitoring Tubing PM6006 because the products were labeled as sterile but were not sterilized.

    Product
    Pressure Monitoring Tubing, PM6006. Pressure Monitoring Tubing (PM series) is used between the manifold and transducer as a conduit to transmit the fluid pressure of the patient to the pressure transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1315-2014·2014-04-09

    Roche Omni Micro-electrode Recalled for Potential Leakage and Erroneous Results

    Roche Diagnostics is recalling Omni Micro-electrodes for cobas b221 analyzers because they may leak if used beyond their 52-week lifetime, potentially causing erroneous pH and sodium results.

    Product
    Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number: 03111873180 as a part of the following systems: 1. 03337103001, cobas b 221<1>Roche OMNI S1 system 2. 03337111001, cobas b 221<2>Roche OMNI S2 system 3. 03337154001,cobas b…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1323-2014·2014-04-09

    Teleflex Recalls Weck Vista Universal Laparoscopic Ports Due to Gas Leakage

    Teleflex Medical is recalling 55,521 Weck Vista Universal Laparoscopic Ports worldwide because they may leak insufflation gas during use.

    Product
    Weck Vista Universal Laparoscopic Port, Size 5/10mm x 100mm, Catalog No. 405910, Weck Vista Universal Laparoscopic Port, Size 5/10/12mm x 100mm, Catalog No. 405912; Weck Vista Universal Laparoscopic Port, Size 5/10/12mm x 125mm, Catalog No. 40591213. An endoscope and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1720-2014·2014-04-09

    Roos Foods Recalls Cultured Sour Cream Due to Listeria Contamination

    Roos Foods Inc. is recalling all brands and sizes of Crema Pura Mexicana cultured sour cream because samples of a related cheese product tested positive for Listeria monocytogenes.

    Product
    Crema Pura Mexicana Brand (Crema Mexicana) Cultured Sour Cream, packaged in a 80 oz Plastic Tub, Grade A, packaged in a 80 oz (5lbs) Plastic Tub, Roos Foods, Inc., Kenton, DE 19955, Plant No. 10-5436, UPC code 095548000247. La Original Crema Pura Mexicana Brand (Crema…
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1314-2014·2014-04-09

    Allesee Orthodontic Jet Appliances Recalled Due to Missing Screw Collar

    Allesee Orthodontic Appliances is recalling 411 Jet appliances because a missing screw collar may prevent intended tooth movement.

    Product
    AOA Distalizer Lock Nut Screw, found in products listed as: Distal Jet, Spring Jet, Mesial Jet, and Uprighter Jet. Removable functional orthodontic appliances that are to modify the growth of the jaws in a prescribed growth pattern.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1328-2014·2014-04-09

    Teleflex Medical Recalls Weck Vista Universal Balloon Open Access Ports

    Teleflex Medical is recalling 55,521 units of Weck Vista Universal Balloon Open Access Ports due to complaints of leakage of insufflation gas through the device.

    Product
    5/10 Weck Vista Universal Balloon Open Access Port - Standard Length (70mm), Catalog No. 410944, 5/10 Weck Vista Universal Balloon Open Access Port - Long Length (100mm), Catalog No. 410944L; 5/10 Weck Vista Universal Balloon Open Access Port - Short Length (53mm), Catalog No.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1318-2014·2014-04-09

    3M Steri-Vac Gas Sterilizers Recalled for Ethylene Oxide Exposure Risk

    3M is recalling Steri-Vac Gas Sterilizers due to a rare failure that could cause ethylene oxide exposure. The issue affects specific models manufactured in late 2006 and 2007.

    Product
    3M" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL The 3M" Steri-Vac" Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for INDOOR USE ONLY.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1331-2014·2014-04-09

    Siemens ACUSON P300 Ultrasound Systems Recalled for Transducer Overheating

    Siemens is recalling ACUSON P300 ultrasound systems with PA230 transducers because they may exceed maximum allowable surface temperature limits.

    Product
    Siemens Medical Solutions, ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe (Esaote product 7348). Provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1330-2014·2014-04-09

    Ormco Recalls Spirit MB Orthodontic Brackets Due to Misplaced ID Dot

    Ormco/Sybronendo is recalling 150 Spirit MB Orthodontic Brackets because a misplaced ID dot may cause incorrect tooth placement.

    Product
    Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081351013. Product Usage: An orthodontic bracket. Spirit MB Brackets are a fixed attachment on a tooth which holds an archwire during orthodontic treatment.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1316-2014·2014-04-09

    Siemens Medical Solutions Recalls IMMULITE 2000 and VersaCell Diagnostic Instruments

    Siemens Medical Solutions Diagnostics is recalling 1,006 IMMULITE 2000, IMMULITE 2000XPi, and VersaCell systems due to a potential for incorrect test results.

    Product
    IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing. The VersaCell system is a robotic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1307-2014·2014-04-09

    RayStation Radiation Therapy Software Recalled for Potential Dose Errors

    RaySearch Laboratories is recalling RayStation Radiation Therapy Treatment Planning System software due to potential dose errors caused by program errors.

    Product
    RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for treatment planning and analysis of radiation therapy.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1313-2014·2014-04-09

    Infantino Teething Ring Recalled Due to Choking Hazard

    Infantino LLC is voluntarily recalling 144,000 units of the Squeeze & Teethe Monkey teething ring because the tail may pose a choking hazard to young children.

    Product
    Infantino Squeeze & Teethe Monkey, "Go Gaga Squeeze & Teether Coco the Monkey". Non-Fluid Filled Teething Ring.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1312-2014·2014-04-09

    Philips Pinnacle3 Radiation Therapy Planning System Software Recall

    Philips is recalling Pinnacle3 Radiation Therapy Planning System software version 9.0 due to a defect that can cause incorrect beam geometry.

    Product
    Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Food)·F-1745-2014·2014-04-09

    Evropa Zele Bonboni Jelly Candy Recalled for Unapproved Colorant

    Fast-Pak Trading Inc. is recalling Evropa Zele Bonboni Jelly Candy in New York because laboratory analysis found the unapproved green colorant chlorophyllin.

    Product
    Evropa Zele Bonboni Jelly Candy Net Wt. 500 g Imported in USA by: Fast-Pak Trading Inc., 375 County Ave., Secaucus, NJ 07094 UPC 5310002480041
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1187-2014·2014-04-09

    Lupin Recalls Suprax Cefixime Oral Suspension Due to Impurity Failure

    Lupin Pharmaceuticals is recalling specific lots of Suprax Cefixime for Oral Suspension because the product failed impurity specifications at the 9-month stability station.

    Product
    Suprax, Cefixime for Oral Suspension USP, 500 mg/5 ml, 20 mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 27437-207-03.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1182-2014·2014-04-09

    Teva Recalls Duloxetine Capsules Due to Reported Breakage

    Teva Pharmaceuticals USA is voluntarily recalling specific lots of Duloxetine Delayed-Release Capsules due to a customer complaint trend regarding capsule breakage.

    Product
    Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx Only, 60 capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7542-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1183-2014·2014-04-09

    Teva Recalls Duloxetine Capsules Due to Reported Capsule Breakage

    Teva Pharmaceuticals USA is voluntarily recalling specific lots of Duloxetine Delayed-Release Capsules due to a customer complaint trend regarding capsule breakage.

    Product
    Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 30 Capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA, 18960, NDC 0093-7543-56
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1188-2014·2014-04-09

    FDA Recalls HydrOXYzine HCl Tablets Due to Unapproved Ingredient Source

    American Health Packaging is recalling HydrOXYzine HCl Tablets because the active pharmaceutical ingredient came from an unapproved source.

    Product
    HydrOXYzine HCl Tablets, USP 25 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-254-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1185-2014·2014-04-09

    Viiv Healthcare Recalls Tivicay Tablets Due to Cross-Contamination with Promacta

    Viiv Healthcare is recalling 1,056 bottles of Tivicay (dolutegravir) 50 mg tablets because they were found to contain Promacta (eltrombopag). The recall covers products distributed nationwide, including Puerto Rico.

    Product
    TIVICAY — TIVICAY (DOLUTEGRAVIR SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1317-2014·2014-04-09

    Stryker Recalls Specific Hip Stems Due to Packaging Error

    Stryker Howmedica Osteonics is recalling 48 Citation V40 Hip Stems because a left-sided implant was found in packaging labeled for a right-sided implant.

    Product
    Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3: catalog # 6265-5113 , Left Size #4: catalog #6265-5104 , and Right Size #4: catalog #6265-5114; Stryker Howmedica Osteonics Hip Implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1184-2014·2014-04-09

    Teva Recalls Duloxetine Capsules Due to Reported Breakage

    Teva Pharmaceuticals USA is voluntarily recalling specific lots of Duloxetine Delayed-Release Capsules due to a customer complaint trend regarding capsule breakage.

    Product
    Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 30 Capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA, 18960, NDC 0093-7544-56
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1321-2014·2014-04-09

    Ormco Recalls Titanium Orthos Brackets Due to Incorrect Color Marking

    Ormco is recalling 150 units of Titanium Orthos Brackets because the color identification dot was marked on the wrong tie-wing.

    Product
    Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot Number 121359169. A fixed attachment on a tooth which holds an archwire during orthodontic treatment.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-1186-2014·2014-04-09

    Lupin Recalls Suprax Cefixime Oral Suspension Due to Impurity Failures

    Lupin Pharmaceuticals is recalling 4,038 bottles of Suprax Cefixime for Oral Suspension because the product failed impurity specifications at the 9-month stability station.

    Product
    Suprax, Cefixime for Oral Suspension USP 500 mg/5 ml, 10mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 27437-207-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1190-2014·2014-04-09

    Teva Recalls QVAR Inhalers Due to Impurity Specification Failures

    Teva Pharmaceuticals is recalling specific lots of QVAR inhalation aerosol because they failed impurity specifications during stability testing.

    Product
    QVAR¿ (beclomethasone dipropionate HFA), C4 INHALATION AEROSOL in Aluminum Cylinders, Mktd by: Teva Respiratory, LLC, Horsham, PA 19044 Mfd by: 3M Drug Delivery Systems, Northridge, CA 91324.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1310-2014·2014-04-09

    Technidata TDWorkstation Software Recalled for Potential Incorrect Patient Demography Transmission

    Technidata S.A. is recalling TDWorkstation software versions 11.01.A and higher because a conflict may cause the system to send incorrect patient demography to connected instruments.

    Product
    TDWorkstation version 11.01.A or higher. TDWorkstation Evolution. TDWorkstation receives patient results from a connected instrument and sends them to a Laboratory Information System (LIS).
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Food)·F-1746-2014·2014-04-09

    Walong Recalls Asian Taste Green Tea Pumpkin Seeds for Unapproved Ingredient

    Walong Marketing is recalling Asian Taste Green Tea Pumpkin Seeds because they contain sodium copper chlorophyllin, an ingredient not permitted in U.S. food products.

    Product
    Asian Taste (Brand) Green Tea Pumpkin Seeds, 8 oz., UPC 673367418186.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V186000·2014-04-08

    Dueco Modified Commercial Vehicles Recalled for Electrical Fire Risk

    Dueco is recalling modified commercial vehicles with Sure Power DC-DC converters where the potting compound may conduct electricity, posing a fire risk.

    Product
    INTERNATIONAL — INTERNATIONAL, FREIGHTLINER, GMC 7400, M2, 4400, C5500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V180000·2014-04-08

    Trans Tech School Bus Seat Anchorage Recall

    Transportation Collaborative, Inc. is recalling 843 Trans Tech school buses because seats may not remain anchored to the floor, increasing injury risk in a crash.

    Product
    TRANS TECH — TRANS TECH SC159DSSA600, ST4, STH4, DW6159FRLSST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V185000·2014-04-08

    Harley-Davidson Recalls 2013-2014 FXSB Motorcycles for Fuel Sensor Issue

    Harley-Davidson is recalling 2013-2014 FXSB and FXSBSE motorcycles because suspension variances may cause the fuel level sensor to read inaccurately, potentially leading to unexpected stalling.

    Product
    HARLEY-DAVIDSON — HARLEY-DAVIDSON FXSB, FXSBSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V178000·2014-04-08

    Peterbilt 587 Recall: Fog Lights May Turn On With High Beams

    PACCAR is recalling 2014-2015 Peterbilt 587 trucks because a software malfunction may cause fog lights to turn on with high beams, potentially blinding oncoming traffic.

    Product
    PETERBILT — PETERBILT 587
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V183000·2014-04-07

    Oshkosh Recalls S-Series Trucks Due to Exhaust Fire Risk

    Oshkosh is recalling 2012-2014 S-Series Ready Mixed Concrete trucks because condensation in the intake manifold may freeze, causing elevated exhaust temperatures or flames that increase the risk of fire or burn injury.

    Product
    OSHKOSH — OSHKOSH S-SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V172000·2014-04-04

    MCI E4500 and J4500 Motorcoaches Recalled for Seat Track Weld Defect

    Motor Coach Industries is recalling 2009-2014 E4500 and J4500 motorcoaches because a missing weld on second-row seat tracks could cause seats to detach in a crash.

    Product
    MCI — MCI E4500, J4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·14144·2014-04-04

    Hussong Recalls Gas Fireplaces and Inserts Due to Explosion Hazard

    Hussong Manufacturing is recalling about 13,600 gas fireplaces and inserts in the U.S. because a control module defect can cause gas buildup and explosions.

    Product
    Kozy Heat, Ambiance and Stellar Hearth gas fireplaces and fireplace inserts
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·021-2014·2014-04-04

    Tyson Recalls Frozen Chicken Nuggets Due to Possible Plastic Contamination

    Tyson Foods is recalling approximately 75,320 pounds of frozen chicken nuggets that may contain small pieces of plastic. The recall affects products shipped to a retail warehouse club and institutional users in Indiana and Arkansas.

    Product
    Tyson Foods, Inc. — Missouri Firm Recalls Chicken Nugget Products Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·14V238000·2014-04-03

    Navistar Recalls 2014 International TranStar Trucks Due to Fire Risk

    Navistar is recalling 2014 International TranStar trucks with specific Cummins engines because condensation may freeze and cause exhaust flames or fire.

    Product
    INTERNATIONAL — INTERNATIONAL TRANSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V173000·2014-04-03

    Mazda Recalls 2014-2015 Models for Potential Engine Stall Risk

    Mazda is recalling 2014-2015 Mazda3 and Mazda6 vehicles because a software error may cause the engine to stall in heavy rain, increasing crash risk.

    Product
    MAZDA — MAZDA MAZDA6, MAZDA3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V170000·2014-04-03

    Mazda Recalls 2014 Mazda6 Vehicles for Fuel Tank Overfill Risk

    Mazda is recalling approximately 19,000 2014 Mazda6 vehicles because the fuel tank can be overfilled, potentially causing gas to leak and increasing fire risk.

    Product
    MAZDA — MAZDA MAZDA6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14C003000·2014-04-03

    Evenflo Recalls Child Seats With Stuck Harness Buckles

    Evenflo is recalling specific convertible and harnessed child seats because the harness buckle may become stuck, making it difficult to remove a child in an emergency.

    Product
    CHILD SEAT:HARNESS/CROTCH BUCKLE recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14727·2014-04-03

    K2 Kwicker Snowboard Bindings Recalled for Unexpected Release Hazard

    K2 Sports is recalling Kwicker and Kwicker BC snowboard bindings because they can release unexpectedly, posing a fall hazard to users.

    Product
    K2 Kwicker and Kwicker BC snowboard bindings
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1227-2014·2014-04-02

    Thoratec HeartMate II Implant Kit Recalled Due to Controller Switching Injuries

    Thoratec is recalling HeartMate II Implant Kits because serious injuries and deaths occurred when patients switched from primary to backup System controllers.

    Product
    HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) with sealed grafts (EU) Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1230-2014·2014-04-02

    Thoratec HeartMate II Pocket Controllers Recalled Due to Reported Deaths

    Thoratec is recalling HeartMate II Pocket Controllers because serious injuries and deaths were reported when patients switched from primary to backup controllers.

    Product
    Heart Mate II Pocket Controllers removed from packaging Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1228-2014·2014-04-02

    Thoratec HeartMate II System Controller Recalled Due to Injury and Death Reports

    Thoratec is recalling HeartMate II System Controllers because serious injuries and deaths occurred when patients switched from primary to backup controllers.

    Product
    HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. It is sometimes called a a heart pump or VAD. HeartMate II is a small implantable LVAD.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1696-2014·2014-04-02

    Kinnikinnick Panko Bread Crumbs Recalled for Undeclared Milk

    World Pure Foods Wholesalers is recalling Kinnikinnick Panko Style Bread Crumbs sold in Michigan due to undeclared milk.

    Product
    Kinnikinnick Panko Style Bread Crumbs-Weight: 350g/12.5oz Cardboard Box UPC 62013360015 3
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1694-2014·2014-04-02

    Kinnikinnick Waffles Recalled for Undeclared Milk Allergen

    World Pure Foods Wholesalers is recalling Kinnikinnick Original Homestyle Waffles sold in Michigan due to undeclared milk.

    Product
    Kinnikinnick Original Homestyle Waffles 210 g/7.4 oz Cardboard Box UPC 620133001981
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-229-2014·2014-04-02

    Thoratec HeartMate II LVAD Pump Recall Due to Controller Switching Injuries

    Thoratec is recalling 36 HeartMate II LVAD Pump and Pocket Controller Kits because switching from the primary to the backup controller caused serious injuries and deaths.

    Product
    HeartMate II LVAD Pump and Pock Controller Kit; Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1702-2014·2014-04-02

    Dole Italian Blend Salad Recalled for Listeria Monocytogenes

    Dole Fresh Vegetables Inc is recalling Italian Blend Salad due to a positive Listeria Monocytogenes test by the Canadian Food Inspection Agency.

    Product
    Italian blend Salad (Romaine Lettuce and Radicchio) packaged under the following brand names: Dole Italian Blend, (UPC 7143000819); Fresh Selections Italian Style Blend (Kroger) (UPC 1111091045); Little Salad Bar Italian Salad, (UPC 4149811014); Marketside Italian Style…
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Food)·F-1699-2014·2014-04-02

    Nutra Balance Pre-Thickened Water Recalled Due to Mold Contamination

    Nutra Balance Products is recalling 432 units of Thickened Water Pudding Thick Phase 3 because the product was found to contain mold.

    Product
    Thickened Water Pudding Thick 32 oz. (944ml) Phase 3 Ingredients: Pasteurized Filtered Water, Cellulose Gum Fibre, Potassium Sorbate.
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-1695-2014·2014-04-02

    Kinnikinnick Waffles Recalled for Undeclared Milk Allergen

    World Pure Foods Wholesalers is recalling Kinnikinnick Cinnamon & Brown Sugar Homestyle Waffles sold in Michigan due to undeclared milk.

    Product
    Kinnikinnick Cinnamon & Brown Sugar Homestyle Waffles 210 g/7.4 oz Cardboard Box UPC 620133001981
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1689-2014·2014-04-02

    Jin Sun Mi Recalls Watermelon Ice Bars for Undeclared Peanuts

    Jin Sun Mi International is recalling watermelon ice bars because they contain undeclared peanuts.

    Product
    Frozen Ice Cake (Watermelon), 17.98 oz, 6 retail units/carton, UPC 8 801062 443055
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1301-2014·2014-04-02

    BioCardia Morph AccessPro Steerable Introducer Recalled for Particulate Risk

    BioCardia is recalling Morph AccessPro Steerable Introducers due to potential particulates in the inner lumen that could cause an embolic event.

    Product
    Morph AccessPro Steerable Introducer; 6F Introducer, 45 cm working length Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or other…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1272-2014·2014-04-02

    Siemens AXIOM Artis Systems Recalled for Potential Gantry Drop Risk

    Siemens is recalling 37 AXIOM Artis angiography systems because a cooling unit defect may cause a system failure and gantry drop.

    Product
    AXIOM Artis Systems Product usage: Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1700·2014-04-02

    Nutra Balance Thickened Water Recalled for Mold and Bacteria

    Nutra Balance Products is recalling Thickened Water Nectar Thick due to FDA findings of mold. A related product also tested positive for bacteria.

    Product
    Thickened Water Nectar Thick 32 oz. (944ml) Phase 1 Ingredients: Pasteurized Filtered Water, Cellulose Gum Fibre, Potassium Sorbate, Citric Acid.
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Devices)·Z-1275-2014·2014-04-02

    Velocity Medical Solutions Recalls DICOM Export Format Software

    Velocity Medical Solutions is recalling DICOM Export Format for Sum Dose v3.0.0 software because it may replace calculated doses in Eclipse treatment plans.

    Product
    DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone software product that provides the oncology care specialists (physicians, physicists, dosimetrists, etc.) a means for comparison of medical imaging data from multiple DICOM conformant imaging modality…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V164000·2014-04-02

    Ford Recalls 2013-2014 Vehicles Due to Weak Seatback Welds

    Ford is recalling 2013-2014 Fusion, Escape, C-Max, and Lincoln MKZ vehicles because sub-standard welds may cause seatbacks to loosen, increasing injury risk in crashes.

    Product
    FORD — FORD, LINCOLN ESCAPE, MKZ, C-MAX, FUSION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·020-2014·2014-04-02

    Backpackers Pantry Recalls Fettuccini Alfredo With Chicken Due to Undeclared Allergens

    American Outdoor Products is recalling 633 pounds of dehydrated Fettuccini Alfredo with Chicken because the packaging contains undeclared milk and wheat allergens.

    Product
    American Outdoor Products, Inc — Colorado Firm Recalls Fettuccini Alfredo With Chicken Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1701-2014·2014-04-02

    Golden Natural Fruit Island Recalled for Undeclared Sulfites and Dye

    Crown Food Distributors is recalling Golden Natural Fruit Island due to undeclared sulfites and FD&C Yellow #6.

    Product
    Golden Natural Fruit Island Net Wt. 25.00 oz Product of Crown Food North Bergen, NJ 07047 Packed by: Crown Food/North Bergen 07047 USA UPC 098346021032
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1698-2014·2014-04-02

    Flying Food Group Recalls Sausage and Egg English Muffins

    Flying Food Group LLC is recalling Good and Fresh brand Sausage & Egg English Muffins because they were assembled with raw sausage meat.

    Product
    Sausage & Egg English Muffin, Good and Fresh brand, 4.1 oz, packaged in clear plastic wrap. UPC 855173005204.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1303-2014·2014-04-02

    Medtronic Recalls FiberNet Embolic Protection System Due to Manufacturing Defect

    Medtronic is recalling specific lots of the FiberNet Embolic Protection System because a yellow polyimide tube was not removed during manufacturing.

    Product
    FIBERNET Embolic Protection System: Recommended Vessel Diameter 3.5 0 5.0 mm, Maximum Guidewire Diameter: 0.014 in ( 0.36 mm) Rx only, Sterile; Manufactured in: Invatec S.P.A., Italy; Manufacturer: Medtronic Inc. Minneapolis, MN. The FiberNet Embolic Protection System…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1278-2014·2014-04-02

    Teleflex Recalls Weck Vista Optical Bladeless Laparoscopic Access Ports

    Teleflex Medical is recalling 55,521 Weck Vista Optical Bladeless Laparoscopic Access Ports due to reported gas leakage that may delay surgical procedures.

    Product
    5/10 mm Weck¿, Vista" Optical Bladeless Laparoscopic Access Port, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1293-2014·2014-04-02

    Teleflex Medical Recalls Polypropylene Sutures for Needle Attachment Defect

    Teleflex Medical is recalling non-absorbable polypropylene sutures because they failed to meet minimum needle attachment strength requirements.

    Product
    Sutures, Non-absorbable, Synthetic, Polypropylene, Sterile, Rx only, Product Usage: Non-absorbable polypropylene surgical suture is a monofilament, Non-absorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1284-2014·2014-04-02

    Teleflex Medical Recalls Weck Vista Universal Cannula Due to Gas Leakage

    Teleflex Medical is recalling 55,521 units of Weck Vista Universal Cannulas because they may leak insufflation gas, potentially delaying laparoscopic surgeries.

    Product
    5/10/12 mm Weck¿ Vista" Universal Cannula, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1693-2014·2014-04-02

    Cookin' Cajun Etouffee Seasoning Blend Recalled for Undeclared Wheat

    Creole Delicacies Kitchens Inc is recalling Cookin' Cajun Acadiana Style Etouffee Seasoning Blend because it contains undeclared wheat flour.

    Product
    Cookin' Cajun (TM) Acadiana Style Etouffee Seasoning Blend, UPC 898851004
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·14E009000·2014-04-02

    Villa Recalls Motorhome Seats Due to Seat Belt Fraying Risk

    Villa International is recalling specific driver and passenger seats used in 2013-2014 Tiffin and American Coach motorhomes because the seat belts may fray and fail to restrain occupants.

    Product
    TIFFIN — TIFFIN, AMERICAN COACH ALLEGRO BUS, AMERICAN TRADITION, EAGLE, AMERICAN REVOLUTION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1291-2014·2014-04-02

    Teleflex Medical Recalls Non-absorbable Polyamide Surgical Sutures

    Teleflex Medical is recalling 32,271 units of non-absorbable polyamide surgical sutures because they failed to meet minimum needle attachment strength requirements.

    Product
    Suture, Non-absorbable, Synthetic, Polyamide, Sterile, Rx only, Product Usage: Non-absorbable polyamide surgical suture is a non-absorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1283-2014·2014-04-02

    Teleflex Vista Optical Bladeless Laparoscopic Access Port Recalled for Gas Leakage

    Teleflex Medical is recalling Vista Optical Bladeless Laparoscopic Access Ports because gas leakage can delay or prevent the completion of laparoscopic surgeries.

    Product
    5/10/12 mm Weck¿ Vista" Optical Bladeless Laparoscopic Access Port, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1285-2014·2014-04-02

    Teleflex Medical Recalls Weck Vista Universal Cone Open Access Devices

    Teleflex Medical is recalling 55,521 Weck Vista Universal Cone Open Access devices due to reported gas leakage that may delay laparoscopic surgeries.

    Product
    5/10/12MM X 100MM Weck¿ Vista" UNIVERSAL CONE OPEN ACCESS, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1683-2014·2014-04-02

    Chicken Soup for the Soul Thai-Style Chicken Broth Recalled for Undeclared Wheat

    Chicken Soup for the Soul is recalling Thai-Style Chicken Broth because it contains undeclared wheat, a major food allergen.

    Product
    Chicken Soup for the Soul Thai-Style Chicken Broth, 32 oz. (2 lb., 907 g. paperboard carton. Distributed by Chicken Soup For The Soul Foods, LLC, Stamford, CT 06902-7532 UPC: 8 19239 01021 2.
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-1276-2014·2014-04-02

    Teleflex Medical Recalls Weck Vista Universal Laparoscopic Ports Due to Gas Leakage

    Teleflex Medical is recalling 55,521 Weck Vista Universal Laparoscopic Ports because they may leak insufflation gas, potentially delaying or complicating laparoscopic surgeries.

    Product
    Weck¿ Vista", Universal Laparoscopic Port, Size 5/10mmx100mm, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1280-2014·2014-04-02

    Teleflex Medical Recalls Weck Vista Universal Laparoscopic Ports Due to Gas Leakage

    Teleflex Medical is recalling 55,521 Weck Vista Universal Laparoscopic Ports because complaints were received regarding leakage of insufflation gas, which can delay surgical procedures.

    Product
    Weck¿ Vista" Universal Laparoscopic Port, Size 5/10/12mmx100mm, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1687-2014·2014-04-02

    Plum Inc. Recalls Stage 2 World Baby Thailand Baby Food Pouches

    Plum Inc. is recalling Stage 2 World Baby Thailand baby food pouches due to intermittent spout damage that may cause plastic fragments to break loose, creating a choking hazard.

    Product
    Stage 2 World Baby Thailand; Roasted Pumpkin & Coconut Rice, 3.5 oz. pouch. Product of USA distributed by Plum Inc., Emeryville, CA
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1287-2014·2014-04-02

    Teleflex Medical Recalls Weck Vista Universal Balloon Open Access Port

    Teleflex Medical is recalling 55,521 units of the Weck Vista Universal Balloon Open Access Port due to reported gas leakage that may delay laparoscopic surgeries.

    Product
    5/10 Weck¿ Vista" Universal Balloon Open Access Port - Long Length (100mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1277-2014·2014-04-02

    Teleflex Medical Recalls 10mm Weck Vista Cannula Due to Gas Leakage

    Teleflex Medical is recalling 55,521 units of 10mm Weck Vista Cannula-only devices due to reported leakage of insufflation gas, which may delay laparoscopic surgeries.

    Product
    10mm Weck¿ Vista" Cannula-only, Teleflex Medical, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1296-2014·2014-04-02

    Teleflex Medical Recalls Silk Sutures Due to Needle Attachment Defect

    Teleflex Medical is recalling 32,271 units of sterile silk sutures because they failed to meet minimum needle attachment strength requirements.

    Product
    Sutures, Non-absorbable, Silk, Sterile, Rx only, Product Usage: Natural non-absorbable silk surgical suture is a non-absorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1295-2014·2014-04-02

    Teleflex Medical Recalls Steel Sutures Due to Needle Attachment Strength Defect

    Teleflex Medical is recalling 32,271 units of non-absorbable steel sutures because they failed to meet minimum needle attachment strength requirements.

    Product
    Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, Rx only, Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1281-2014·2014-04-02

    Teleflex Medical Recalls Weck Vista Universal Laparoscopic Ports

    Teleflex Medical is recalling 55,521 Weck Vista Universal Laparoscopic Ports due to reported gas leakage that may delay surgical procedures.

    Product
    Weck¿ Vista" Universal Laparoscopic Port, Size 5/10/12mmx125mm, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
    Category
    Medical Device
    Distribution
    Distributed nationwide

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