The Recall Desk

Archive

March 2016 recalls

772 recalls were announced in March 2016.

What the numbers show

Critical
29
Severe
169
High
353
Moderate
197
Low
24

Of the 772 recalls this month scored against our rubric, 4% are Critical, 22% are Severe.

501–600 of 772

  • ModerateFDA (Food)·F-0697-2016·2016-03-09

    Smith's Country Cheese-Gouda with Bacon Spread Recalled for Non-Pathogenic E. Coli

    Smith's Country Cheese, Inc. is recalling 8 oz. containers of Gouda with Bacon Spread due to contamination with non-pathogenic E. Coli. The product was distributed in Georgia, New Hampshire, and Massachusetts.

    Product
    Smith's Country Cheese-Gouda with Bacon Spread packaged in 8 oz. plastic container
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0696-2016·2016-03-09

    Smith's Country Cheese Gouda Recalled for Non-Pathogenic E. Coli

    Smith's Country Cheese is recalling Gouda with Herb Spread due to non-pathogenic E. Coli contamination. The product was distributed in Georgia, New Hampshire, and Massachusetts.

    Product
    Smith's Country Cheese-Gouda with Herb Spread packaged in 8 oz. plastic container
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0693-2016·2016-03-09

    Smith's Creamy Gouda Spread Recalled for Non-Pathogenic E. Coli

    Smith's Country Cheese is recalling Creamy Gouda Spread due to contamination with non-pathogenic E. Coli. The product was distributed in Georgia, New Hampshire, and Massachusetts.

    Product
    Smith's Country Cheese -Creamy Gouda Spread packaged in 8 oz. plastic container
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0694-2016·2016-03-09

    Smith's Country Cheese Creamy Gouda Recalled for Non-Pathogenic E. Coli

    Smith's Country Cheese is recalling Creamy Gouda with Wine Spread due to contamination with non-pathogenic E. Coli. The product was distributed in Georgia, New Hampshire, and Massachusetts.

    Product
    Smith's Country Cheese- Creamy Gouda with Wine Spread packaged in 8 oz. plastic container
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1019-2016·2016-03-09

    Virage OCT Spinal Fixation System Recall for Updated Surgical Guidance

    Zimmer Spine is issuing a Class II correction for the Virage OCT Spinal Fixation System to provide additional guidance in the surgical technique manual.

    Product
    Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0702-2016·2016-03-09

    Nutrifruit Freeze Dried Black Raspberry Powder Recalled for Labeling Error

    Scenic Fruit Company is recalling Nutrifruit Freeze Dried Black Raspberry Powder because the label incorrectly states 0 grams of sugar per serving instead of 2 grams.

    Product
    Freeze Dried Black Raspberry Powder, Item no. 30007 or 30041. Nutrifruit brand. Each plastic jar has a net wt. 5 oz. The UPC is 0 79947 00019 0.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-0695-2016·2016-03-09

    Smith's Country Cheese Gouda Spread Garlic Recalled for E. Coli

    Smith's Country Cheese is recalling Gouda Spread Garlic due to contamination with non-pathogenic E. Coli. The product was distributed in Georgia, New Hampshire, and Massachusetts.

    Product
    Smith's Country Cheese -Gouda Spread Garlic packaged in 8 oz. plastic container
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1043-2016·2016-03-09

    Aesculap Recalls Mislabelled Knee Implant Packaging for Cementless Use

    Aesculap Inc. is recalling 1,232 units of Columbus Revision and EnduRo Knee System packaging labeled as cementless, which are indicated for use with bone cement only.

    Product
    Columbus Revision Knee System, EnduRo Knee System Product Usage: The Columbus Revision Knee System and EnduRo Knee System are indicated for use in reconstruction of the diseased knee joint.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1020-2016·2016-03-09

    Philips Recalls BrightView Gamma Cameras Due to Motion and Collision Issues

    Philips Medical Systems is recalling 677 BrightView gamma cameras because the collimator may contact the patient pallet or the gantry may halt prematurely during scans.

    Product
    BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1042-2016·2016-03-09

    Volcano Sterile Equipment Covers Recalled for Incorrect Expiry Date Labeling

    Volcano Corporation is recalling certain lots of R-100 Sterile Equipment Covers because the outer shipping boxes may display incorrect expiry dates, although the inner product is correctly labeled.

    Product
    Volcano SpinVision Sterile Equip cover II; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be sterilized. The sterile drapes are put over this equipment in case any steri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0700-2016·2016-03-09

    Smith's Country Cheese Gouda Spread Recalled for Non-Pathogenic E. Coli

    Smith's Country Cheese is recalling Gouda with Onion and Chive Spread due to contamination with non-pathogenic E. Coli. The product was distributed in Georgia, New Hampshire, and Massachusetts.

    Product
    Smith's Country Cheese-Gouda with with Onion and Chive Spread packaged in 8 oz. plastic container
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1034-2016·2016-03-09

    FDA Recalls Mispackaged Pediatric Feeding Tubes from Covidien

    The FDA is recalling 1,330 units of pediatric feeding tubes due to packaging errors where different tube sizes were placed in incorrect packages.

    Product
    Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 8 Fr/Ch (2.7 mm) x 20" (51 cm); Catalog Number: 461701. Intended for pediatric feeding.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-0692-2016·2016-03-09

    Smith's Gouda Cheese Recalled for Non-Pathogenic E. Coli Contamination

    Smith's Country Cheese is recalling specific lots of Gouda cheese due to contamination with non-pathogenic E. Coli. The product was distributed in Georgia, New Hampshire, and Massachusetts.

    Product
    Gouda Cheese packaged under the brand names: Smith's Farmstead Gouda and Jansal Valley Mountain Gouda, Packaged in 11 lb. waxed wheel in saran wrap. 5 lb. Half wheels wrapped in shrink pack packaging.
    Category
    Food
    Distribution
    2 states
  • LowFDA (Drugs)·D-0734-2016·2016-03-09

    J. Strickland Recalls Subpotent Sulfur8 Anti-Dandruff Conditioner

    J. Strickland and Co is recalling Sulfur8 Medicated Light Formula anti-dandruff conditioner because it failed stability testing. The product is subpotent.

    Product
    sulfur8 medicated LIGHT FORMULA (sulfur) anti-dandruff hair & scalp conditioner, 2%, packaged in a) 2 OZ (57g) jar (UPC 0 75610 43510 8), and b) 4 OZ (113g) jar (UPC 0 75610 43610 5), 1 dozen jars per case, J. Strickland & Co., PO Box 1637, Olive Branch, MS 38654
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0713-2016·2016-03-09

    Frozen Specialties Recalls Food Lion Crispy Thin Crust Pizza for Kosher Labeling

    Frozen Specialties Inc is recalling Food Lion microwaveable crispy thin crust pizza because the packaging displays a Kosher symbol that does not represent actual Kosher status.

    Product
    FOOD LION CHEESE microwaveable crispy thin crust pizza KEEP FROZEN NET WT 5.2 OZ (147Gg) (U) INGREDIENTS: CRUST***SAUCE***MOZZARELLA CHEESE BLEND***CONTAINS: WHEAT, SOY, MILK. DISTRIBUTED BY: FOOD LION, LLC, SALISBURY, NC 28147 UPC 0 35826 08821 5
    Category
    Food
    Distribution
    5 states
  • LowFDA (Food)·F-0711-2016·2016-03-09

    Frozen Specialties Recalls Hannaford Cheese Pizza for Kosher Labeling Error

    Frozen Specialties Inc is recalling Hannaford Cheese Crispy Thin Crust Pizza because the packaging displays a Kosher symbol, although the product is not Kosher.

    Product
    Hannaford CHEESE crispy thin crust pizza KEEP FROZEN NET WT 5.2 OZ (147Gg) (U) INGREDIENTS: CRUST***SAUCE***MOZZARELLA CHEESE BLEND***CONTAINS: WHEAT, SOY, MILK. DISTRIBUTED BY: HANNAFORD BROS. CO., SCARBOROUGH, ME 04074 UPC 0 41268 19400 1
    Category
    Food
    Distribution
    5 states
  • LowFDA (Food)·F-0712-2016·2016-03-09

    Frozen Specialties Recalls Food Lion Pizza for Misleading Kosher Labeling

    Frozen Specialties Inc is recalling Food Lion Cheese Crispy Thin Crust Pizza because the packaging displays a Kosher symbol, but the products are not Kosher.

    Product
    FOOD LION CHEESE crispy thin crust pizza KEEP FROZEN NET WT 5.2 OZ (147Gg) (U) INGREDIENTS: CRUST***SAUCE***MOZZARELLA CHEESE BLEND***CONTAINS: WHEAT, SOY, MILK. DISTRIBUTED BY: FOOD LION, LLC, SALISBURY, NC 28147 UPC 0 35826 08815 4
    Category
    Food
    Distribution
    5 states
  • SevereNHTSA·16V142000·2016-03-08

    Setra Recalls 2005-2009 S417 Coaches Due to Control Arm Defect

    Setra is recalling 2005-2009 S417 coaches because a cracked control arm tube can separate, potentially causing loss of vehicle control and increasing crash risk.

    Product
    SETRA — SETRA S417
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16E018000·2016-03-07

    ZF Front Control Arm Recall Due to Potential Tube Separation

    ZF Group is recalling specific front control arms where a manufacturing defect may cause the tube to separate from the shaft, potentially leading to loss of vehicle control.

    Product
    SUSPENSION:FRONT:CONTROL ARM recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V139000·2016-03-07

    Thor Motor Coach Recalls 2014-2016 Hurricane and Windsport Motor Homes

    Thor Motor Coach is recalling 385 model year 2014-2016 Hurricane and Windsport motor homes because heat from the exhaust system may cause a storage compartment to melt, increasing the risk of fire.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH, THOR MOTOR HURRICANE, WINDSPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V138000·2016-03-07

    Volkswagen Recalls 2015-2016 e-Golf Vehicles for Battery Software Defect

    Volkswagen is recalling 2015-2016 e-Golf vehicles because oversensitive battery diagnostics may cause the electric motor to shut down unexpectedly, increasing crash risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN E-GOLF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V137000·2016-03-07

    Jaguar Recalls 2013-2015 XF Vehicles for Power Steering Defect

    Jaguar is recalling 2013-2015 XF vehicles because a faulty engine component may cause a loss of power steering assist, increasing crash risk.

    Product
    JAGUAR — JAGUAR XF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·pha-030716·2016-03-07

    Yummy Chicken Breast Nuggets Recalled for Metal Contamination

    USDA FSIS issued a public health alert for Yummy brand chicken nuggets potentially contaminated with metal pieces. No illnesses have been reported.

    Product
    FSIS Issues Public Health Alert For Imported Chicken Product For Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·023-2016·2016-03-05

    Perdue Recalls Applegate Chicken Nuggets Due To Plastic Contamination

    Perdue Foods is recalling Applegate Naturals Chicken Nuggets due to possible plastic contamination. No illnesses have been reported.

    Product
    Gold Creek Foods, LLC — Perdue Foods LLC, Recalls Chicken Nugget Products Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    7 states
  • SevereNHTSA·16V131000·2016-03-04

    Prevost Recalls X3-45 Buses Due to Cracking Passenger Seat Frames

    Prevost is recalling 2015-2016 X3-45 buses because cracks in sliding passenger seats may compromise structural integrity, increasing injury risk in crashes.

    Product
    PREVOST — PREVOST X3-45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V133000·2016-03-04

    Prevost Recalls Coaches Due to Fuel Line Fire Risk

    Prevost is recalling specific 2011-2016 coach models because a missing clip allows the coolant line to rub against the fuel hose, potentially causing a fuel leak and engine compartment fire.

    Product
    PREVOST — PREVOST X3-45 COACH, XL2 ENTERTAINER, H3-41, H3-45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V136000·2016-03-04

    Club Car Precedent Golf Carts Recalled for Missing Safety Equipment

    Hardkore Karts is recalling 2009-2013 Club Car Precedent golf carts with street packages that lack required VINs, certification labels, and DOT-compliant windshields.

    Product
    CLUB CAR — CLUB CAR PRECEDENT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V135000·2016-03-04

    Nova Bus Recalls 2014-2016 LFS Models for Wiper Arm Defect

    Nova Bus is recalling 863 LFS and LFS Artic buses from 2014-2016 because a wiper idler arm pin may strip, causing wipers to stop working and reducing visibility.

    Product
    NOVA BUS — NOVA BUS LFS, LFS ARTIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V132000·2016-03-04

    Haulmark Motorcoach Recall for Unstable Entry Steps

    Universal Trailer is recalling 2007-2010 Haulmark Motorcoaches because a bolt may fracture, causing entry steps to become unstable and increasing injury risk.

    Product
    HAULMARK — HAULMARK MOTORCOACH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V127000·2016-03-03

    Toyota and Lexus Recall for Front Passenger Air Bag Inflator Rupture Risk

    Toyota is recalling specific 2008-2010 Lexus SC, Corolla, Corolla Matrix, and Pontiac Vibe vehicles because the front passenger air bag inflator may rupture during deployment.

    Product
    LEXUS — LEXUS, TOYOTA, PONTIAC SC, COROLLA MATRIX, COROLLA, VIBE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·022-2016·2016-03-03

    Namias of Arizona Recalls Chicken Products for Undeclared Soy Allergen

    Namias of Arizona is recalling approximately 19,200 pounds of fully cooked chicken products due to misbranding and an undeclared soy allergen.

    Product
    Carlotta's Kitchen LLC — Namias of Arizona Recalls Chicken Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    2 states
  • HighCPSC·16113·2016-03-03

    Pelican Flashlights and Battery Packs Recalled for Fire Hazard

    Pelican Products is recalling specific 9410L flashlights and replacement battery packs because the lithium-ion batteries can overheat and cause fires. No injuries have been reported.

    Product
    Pelican flashlights and replacement battery packs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0628-2016·2016-03-02

    Mahina Mele Farm Recalls Salted Macadamia Nuts Due to Salmonella

    Mahina Mele Farm is recalling salted macadamia nuts because samples tested positive for Salmonella. Consumers should stop eating the product and return it to the store.

    Product
    Izzie Macs! Macadamia Nuts - Salted. Certified Organic Macadamia Nuts, 100% Big Island Grown A raw food. Sold in 6 oz. plastic bag and 16 oz. plastic bag. UPC - 6 oz.: 689076792677; UPC 16 oz.: 689076792974. Mahina Mele Farm 87-2642 Mamalahoa Hwy. Captain Cook, HI 967
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0630-2016·2016-03-02

    Mahina Mele Farm Recalls Bulk Macadamia Nuts Due to Salmonella

    Mahina Mele Farm is recalling bulk macadamia nuts because samples tested positive for Salmonella. The recall covers all lots currently in commerce.

    Product
    Bulk Macadamia Nuts - (salted, unsalted; whole and pieces) Certified Organic Macadamia Nuts, 100% Big Island Grown A raw food. Sold in 5 lb. bag. NO UPC number. Mahina Mele Farm 87-2642 Mamalahoa Hwy. Captain Cook, HI 96704
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0800-2016·2016-03-02

    Cook Inc. Recalls Single Lumen Pressure Monitoring Sets Due to Tip Fracture

    Cook Inc. is recalling 2,280 single-lumen pressure monitoring sets and trays because a manufacturing defect may cause catheter tips to fracture or separate.

    Product
    Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·16E017000·2016-03-02

    Bergstrom Air Conditioner Recall for Fire Risk in Freightliner Trucks

    Bergstrom is recalling ParkSmart HVAC units for Freightliner Cascadia trucks due to a connector defect that may cause overheating and increase the risk of a fire.

    Product
    EQUIPMENT:APPLIANCE:AIR CONDITIONER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0801-2016·2016-03-02

    Cook Inc. Recalls Femoral Artery Pressure Monitoring Catheters Due to Tip Fracture Risk

    Cook Inc. is recalling specific femoral artery pressure monitoring catheter sets and trays because a manufacturing defect may cause the catheter tip to fracture or separate.

    Product
    Femoral Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0726-2016·2016-03-02

    Keystone Recalls Medicated Better Braids Spray Due to Staphylococcus aureus

    Keystone Laboratories is recalling Medicated Better Braids, La Laque (salicylic acid) Spray due to a positive Staphylococcus aureus test result.

    Product
    Medicated Better Braids, La Laque (salicylic acid) Spray, 2%,12 Fl. OZ. (355 ml.) bottle, Distributed by Keystone Laboratories, Memphis, TN 38101-2026, UPC 0 70596 00422 5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0798-2016·2016-03-02

    Cook Inc. Recalls Shuttle Select Slip-Cath Catheters Due to Tip Splits

    Cook Inc. is recalling 9,519 Shuttle Select Slip-Cath Catheters worldwide due to reports of catheter tip splits and separation, which can cause loss of function or complications.

    Product
    Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular syst
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0866-2016·2016-03-02

    GSI Group Recalls PRN 50-M+ Paper Chart Recorders for Fire Risk

    GSI Group Inc. is recalling 2,257 PRN 50-M+ Paper Chart Recorders due to a risk of fire or electrical shock.

    Product
    PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01 Product Usage: The PRN 50M+ Paper Chart Recorder thermally records patient data on a paper strip. This device is intended for use under direct supervision of a licensed health care practitioner. Thi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0624-2016·2016-03-02

    CSFPDX Recalls Wild Albacore Tuna Cans Due to Under-Processing Concerns

    CSFPDX, LLC is voluntarily recalling 142 cans of Wild Albacore Tuna because they may be under-processed, posing a risk of Clostridium botulinum contamination.

    Product
    Labeled "CSFISHERY COMMUNITY SUPPORTED FISHERY Wild Albacore Tuna, 64 oz.., Ingredients: Oregon Albacore Tuna, Sea Salt" Label is black ink on an off white label. No UPC
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0921-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 326 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548350 (XMD P/N 70-0050-214) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0975-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem Mediem Medical Devices Inc is recalling 36 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number M00548430 (XMD P/N 70-0050-A14) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The Endo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0827-2016·2016-03-02

    Draeger Medical Recalls Evita and Babylog Ventilators Due to Battery Defect

    Draeger Medical is recalling Evita Infinity V500 and Babylog Infinity VN500 ventilators because the optional PS500 power supply unit batteries may discharge prematurely despite showing adequate charge.

    Product
    Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0935-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 189 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548530 (XMD P/N 70-0050-416) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0930-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage

    Xeridiem is recalling 34 EndoVive 3s Low Profile Balloon Kits because the feeding valve may leak gastric contents when disconnected.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548840 (XMD P/N 70-0050-320) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0981-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem Mediem Medical Devices Inc is recalling 39 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548320 (XMD P/N 70-0050-B12) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0632-2016·2016-03-02

    Mahina Mele Farm Recalls Raw Macadamia Nut Butter for Salmonella

    Mahina Mele Farm is recalling Baby Bruddah's Chocolate Mac Nut Buttah because samples tested positive for Salmonella.

    Product
    Baby Bruddah's Chocolate Mac Nut Buttah; Certified Organic by International Certification Services Inc. From the Big Island, A raw food. Sold in 12 oz. plastic tub. UPC number: 75318224204 Mahina Mele Farm 87-2642 Mamalahoa Hwy. Captain Cook, HI 96704
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0992-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 126 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00549420 (XMD P/N 70-0050-C22) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V128000·2016-03-02

    Toyota and Lexus Recall Vehicles for Air Bag Inflator Rupture Risk

    Toyota is recalling specific 2008-2010 Lexus SC, Corolla, Corolla Matrix, and Pontiac Vibe vehicles because the passenger air bag inflator may rupture during deployment.

    Product
    TOYOTA — TOYOTA, LEXUS, PONTIAC COROLLA MATRIX, SC, COROLLA, VIBE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0799-2016·2016-03-02

    Cook Inc. Recalls Single Lumen Central Venous Catheter Sets

    Cook Inc. is recalling 1,341 single-lumen central venous catheter sets and trays due to a manufacturing defect that may cause catheter tip fracture or separation.

    Product
    Single Lumen Central Venous Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0912-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage

    Xeridiem is recalling 36 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548460 (XMD P/N 70-0050-D14) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0899-2016·2016-03-02

    Olympus Video Gastroscope Recalled Due to Internal Coil Detachment Risk

    Integrated Medical Systems Inc. is recalling nine Olympus GIF-Q140 video gastroscopes because excessive pressure can cause the internal coil pipe to detach, preventing proper angulation.

    Product
    Olympus, Model No. GIF-Q140, flexible scope, large diameter, video gastroscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V125000·2016-03-02

    GM Recalls 2016 Chevrolet and GMC Vehicles for Air Bag Defect

    General Motors is recalling specific 2016 Chevrolet Colorado, Malibu, and GMC Canyon vehicles because the driver's air bag may inflate improperly during a crash, increasing injury risk.

    Product
    CHEVROLET — CHEVROLET, GMC COLORADO, CANYON, MALIBU
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0913-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage

    Xeridiem Mediem Medical Devices is recalling 91 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, causing leakage.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548330 (XMD P/N 70-0050-014) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0853-2016·2016-03-02

    Philips IntelliVue Measurement Module X1 Recalled for ST Alarm Failure

    Philips is recalling 13,300 IntelliVue Measurement Module X1 units because the ST elevation alarm may not sound for specific ECG leads.

    Product
    Philips IntelliVue Measurement Module X1 Model: M3001A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0906-2016·2016-03-02

    Olympus Video Gastroscope Recall Due to Internal Coil Detachment Risk

    Integrated Medical Systems Inc is recalling four Olympus GIF-XQ140 video gastroscopes because excessive pressure can cause the internal coil pipe assembly to detach, preventing proper angulation.

    Product
    Olympus, Model No. GIF-XQ140, flexible scope, large diameter, video gastroscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0971-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem Mediem Medical Devices Inc is recalling 36 EndoVive 3s Low Profile Balloon Kits due to a feeding valve leakage issue that may allow gastric contents to leak out.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548900 (XMD P/N 70-0050-920) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0937-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem Mediem Medical Devices is recalling 37 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548850 (XMD P/N 70-0050-420) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0982-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 36 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548440 (XMD P/N 70-0050-B14) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1012-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage

    Xeridiem is recalling 39 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548650 (XMD P/N 70-0050-G16) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0940-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 39 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548260 (XMD P/N 70-0050-512) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0929-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage

    Xeridiem Mediem Medical Devices is recalling 78 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548680 (XMD P/N 70-0050-318) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0952-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 35 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00549360 (XMD P/N 70-0050-622) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1009-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may leak gastric contents or feeding solution when disconnected.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00549450 (XMD P/N 70-0050-F22) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0976-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548590 (XMD P/N 70-0050-A16) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0898-2016·2016-03-02

    Olympus CF-Q160L Video Colonoscopes Recalled for Detached Internal Coil Pipe Assembly

    Integrated Medical Systems Inc is recalling 26 Olympus CF-Q160L video colonoscopes because excessive pressure can cause the internal coil pipe assembly to detach, preventing angulation from operating as intended.

    Product
    Olympus, Model No. CF-Q160L, flexible scope, large diameter, video colonoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0926-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 235 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548240 (XMD P/N 70-0050-312) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0901-2016·2016-03-02

    Olympus Video Colonoscopes Recalled Due to Internal Coil Detachment Risk

    Integrated Medical Systems Inc is recalling 122 Olympus video colonoscopes because excessive pressure may cause the internal coil pipe assembly to detach, affecting angulation.

    Product
    Olympus, Model No. PCF-Q180AL, flexible scope, large diameter, video colonoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1005-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 36 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548480 (XMD P/N 70-0050-F14) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0826-2016·2016-03-02

    Siemens Syngo Dynamics Software Recalled for Potential Patient Data Mixing

    Siemens is recalling Syngo Dynamics PACS software because it may mix data from multiple patients in echo trend graphs.

    Product
    software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Syngo Dynamics is not intended to be used f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0914-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 260 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548220 (XMD P/N 70-0050-112) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0852-2016·2016-03-02

    Stryker Spine Recalls AccuLIF Tubing Sets Due to Interference

    Stryker Spine is recalling 413 AccuLIF PL and TL Tubing Sets because two potential interference conditions were identified with how the tubing attaches to the inserter.

    Product
    AccuLIF PL Tubing Set and AccuLIF TL Tubing Set AccuLIF is an interbody device system that uses hydraulic pressure to expand the implant in-situ. The purpose of the AccuLIF PL Tubing Set (cat#900301) and AccuLIF TL Tubing Set (cat#905103) is to deliver pressurized saline from
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0888-2016·2016-03-02

    Siemens Mammomat Inspiration Recall for Potential System Fatal Error

    Siemens is recalling 76 Mammomat Inspiration units because a system fatal error may occur during tomosynthesis reconstruction for large breasts, causing the process to abort.

    Product
    Mammomat Inspiration with Tomosynthesis functionality
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0972-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage

    Xeridiem is recalling 37 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, causing leakage of feeding solution or gastric contents.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00549390 (XMD P/N 70-0050-922) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0621-2016·2016-03-02

    Mary's Gone Crackers Thins Recalled for Potential Gluten Contamination

    Mary's Gone Crackers, Inc. is recalling specific lots of gluten-free Thins snack crackers because they may contain gluten levels above the FDA limit.

    Product
    Mary's Gone Crackers Thins, Light and Tasty Snack Crackers; Lightly salted. Organic, gluten free, non gmo, vegan; NET WT. 4.5 oz (127 g); UPC: 10897580000707; Mary's Gone Crackers, Inc. 199 Kentucky St., Gridley, CA 95948
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-0946-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 34 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M005489490 (XMD P/N 70-0050-524) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The En
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0893-2016·2016-03-02

    Olympus Video Gastroscope Recall Due to Detached Internal Coil Assembly

    Integrated Medical Systems Inc is recalling 180 Olympus GIF-H180J video gastroscopes because excessive pressure can cause the internal coil pipe assembly to detach, preventing proper angulation.

    Product
    Olympus, Model No. GIF-H180J, flexible scope, large diameter, video gastroscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0915-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 199 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548340 (XMD P/N 70-0050-114) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0960-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 43 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00549510 (XMD P/N 70-0050-724) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0945-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem Mediem Medical Devices Inc is recalling 36 EndoVive 3s Low Profile Balloon Kits because the feeding valve may leak gastric contents.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M005489350 (XMD P/N 70-0050-522) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The En
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0934-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 323 EndoVive 3s Low Profile Balloon Kits because the feeding valve may leak gastric contents or feeding solution.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548370 (XMD P/N 70-0050-414) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0897-2016·2016-03-02

    Olympus Video Colonoscope Recall Due to Internal Coil Detachment Risk

    Integrated Medical Systems is recalling five Olympus video colonoscopes because the internal coil pipe assembly may detach if excessive pressure is applied to the distal end.

    Product
    Olympus, Model No. PCF-160AL, flexible scope, large diameter, video colonoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0942-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 186 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548540 (XMD P/N 70-0050-516) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0933-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage

    Xeridiem is recalling 38 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548250 (XMD P/N 70-0050-412) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1006-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 31 EndoVive 3s Low Profile Balloon Kits because the feeding valve may leak gastric contents or feeding solution when disconnected.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548640 (XMD P/N 70-0050-F16) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0924-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548830 (XMD P/N 70-0050-220) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0904-2016·2016-03-02

    Olympus Video Gastroscope Recall Due to Internal Coil Detachment Risk

    Integrated Medical Systems Inc. is recalling 54 Olympus GIF-Q160 video gastroscopes because excessive pressure may cause the internal coil pipe assembly to detach, preventing proper angulation.

    Product
    Olympus, Model No. GIF-Q160, flexible scope, large diameter, video gastroscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0896-2016·2016-03-02

    Olympus Video Colonoscopes Recalled Due to Internal Coil Detachment Risk

    Integrated Medical Systems Inc is recalling 82 Olympus CF-Q180AL video colonoscopes because excessive pressure may cause the internal coil pipe to detach, preventing proper angulation.

    Product
    Olympus, Model No. CF-Q180AL, flexible scope, large diameter, video colonoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0824-2016·2016-03-02

    Siemens BCS Blood Coagulation Analyzer Recall for False Results

    Siemens is recalling BCS Automated Blood Coagulation Analyzer Systems because they may produce falsely short clotting times and low PT INR values when testing specific types of patient samples.

    Product
    BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10454728 (BCS RECONDITIONED), 10454729 (BCS RECONDITIONED), 10454742 (BEHRING COAGULATION SYSTEM), 10459303 (BCS RECONDITIONED), 10460659 (BCS INSTRUMENT), 1046
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0927-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 331 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548360 (XMD P/N 70-0050-314) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0951-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 37 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548870 (XMD P/N 70-0050-620) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide

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