The Recall Desk

Archive

October 2016 recalls

1,035 recalls were announced in October 2016.

What the numbers show

Critical
136
Severe
242
High
453
Moderate
173
Low
31

Of the 1,035 recalls this month scored against our rubric, 13% are Critical, 23% are Severe.

201–300 of 1035

  • HighFDA (Devices)·Z-0138-2017·2016-10-26

    Olympus OER-Pro Endoscope Reprocessor Recall Issued for Cleaning Instructions

    Olympus is recalling OER-Pro endoscope reprocessors because instructions may incorrectly suggest skipping precleaning steps. Users must conduct manual cleaning.

    Product
    OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-0218-2017·2016-10-26

    Windstone Medical Recalls Lap/Pelviscopy Packs Due to Sterility Compromise

    Windstone Medical Packaging is recalling 258 Lap/Pelviscopy Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Lap/Pelviscopy Pack, Kit number AMS4151, PSS3256, PSS3256(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0140-2017·2016-10-26

    Kabobs Recalls Coconut Lobster Tail Due to E. coli O121 Contamination

    Kabobs Inc is recalling Coconut Lobster Tail because it was manufactured with flour contaminated with E. coli O121.

    Product
    COCONUT LOBSTER TAIL, 100 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0181-2017·2016-10-26

    Windstone ENT Surgical Kits Recalled for Potential Sterility Compromise

    Windstone Medical Packaging is recalling 123 ENT surgical kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    ENT Pack, Kit number AMS2727, AMS3237(A, and AMS4214. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0152-2017·2016-10-26

    Union Bagel Shop Recalls Double Cheese Bagels for Undeclared Allergens

    Union Bagel Shop is recalling Double Cheese bagels because the packaging fails to declare wheat and milk ingredients.

    Product
    Package contains a business card for "***BAGEL SHOP***" "***Double Cheese: Flour, Filtered Water, Organic Shortening, Olive Oil, Malt, Sugar, Sea Salt, Yeast, Cheddar Cheese & Swiss Cheese.***" 2 bagels per package - plastic bag with twist tie.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0168-2017·2016-10-26

    Windstone Medical Recalls Custom Venous Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 1,584 Custom Venous Kits because the Medtronic gloves included in the kits may contain splits or holes that compromise sterility.

    Product
    Custom Venous Kit, TVS4024(C convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0179-2017·2016-10-26

    Windstone Medical Recalls Surgical Procedure Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 666 Dr. Newman Surgical Procedure Packs because the Medtronic gloves inside may contain splits or holes that compromise sterility.

    Product
    Dr. Newman Surgical Procedure Pack, kit numbers PSS1689 PSS1689(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0244-2017·2016-10-26

    Windstone Medical Recalls Surgical Kits Due to Potential Sterility Compromise

    Windstone Medical Packaging is recalling 360 Minor/General/Ortho Packs because Medtronic gloves inside may have splits or holes that compromise sterility.

    Product
    Minor/General/Ortho Pack, Kit number PSS3258, PSS3258(A, and PSS3258(B convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0279-2017·2016-10-26

    Windstone Medical Recalls Universal Surgery Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 99 Universal Pack surgery kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Universal Pack, Kit number AMS2036 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0132-2017·2016-10-26

    Kabobs Vegetable Samosa Recalled Due to E. coli O121 Contaminated Flour

    Kabobs Inc is recalling Vegetable Samosa prepared with flour contaminated with E. coli O121. The product was distributed across multiple states.

    Product
    VEGETABLE SAMOSA, 100 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Food)·F-0150-2017·2016-10-26

    Union Bagel Shop Recalls Onion and Garlic Bagels for Undeclared Wheat

    Union Bagel Shop is recalling Onion/Garlic bagels due to undeclared wheat. The product was sold at one retail store in Grande, Oregon.

    Product
    Package contains a business card for "***BAGEL SHOP***" "***Onion/Garlic: Flour, Filtered Water, Organic Shortening, Olive Oil, Malt, Sea Salt, Sugar, Yeast, Onion & Garlic Flakes.***" 2 bagels per package - plastic bag with twist tie.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0131-2017·2016-10-26

    Kabobs Recalls Shrimp Empanadas Due to E. coli O121 Contamination

    Kabobs Inc is recalling Shrimp Empanadas because they were manufactured with flour contaminated with E. coli O121.

    Product
    SHRIMP EMPANADA Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0199-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic is recalling COVER LIGHT HANDLE DISPOSABLE GLOVES because splits or holes may compromise sterility in custom surgical kits.

    Product
    GLBSC Minor Pack, Kit number PSS2644 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·17021·2016-10-26

    H-E-B Recalls Brazos Embossed Star Chairs Due to Fall Hazard

    H-E-B is recalling Brazos Embossed Star Chairs because weld defects may cause armrests to detach, posing a fall hazard. No injuries have been reported.

    Product
    Brazos Embossed Star Chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0215-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    The FDA is recalling Medtronic disposable gloves used in Lap Band kits because splits or holes may compromise sterility.

    Product
    Lap Band Pack, Kit number AMS1785(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0120-2017·2016-10-26

    Kabobs Recalls Panang Shrimp Prepared with E. coli Contaminated Flour

    Kabobs Inc is recalling Panang Shrimp prepared with flour contaminated with E. coli O121. The product was distributed to multiple states.

    Product
    PANANG SHRIMP, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0262-2017·2016-10-26

    Windstone Medical Recalls Surgical Kits Due to Potential Sterility Compromise

    Windstone Medical Packaging is recalling 1,164 custom surgical kits because the disposable gloves included may contain splits or holes that compromise sterility.

    Product
    Plastic Kit, Kit number CMP1084(B convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0182-2017·2016-10-26

    Windstone Medical ENT Surgery Kits Recalled for Sterility Compromise

    Windstone Medical Packaging is recalling 1,795 ENT surgery kits because the disposable gloves included may have splits or holes that compromise sterility.

    Product
    ENT Tray, Kit number AMS1195(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0177-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility.

    Product
    Dr. Harrimans Kit, Kit number PSS3600 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0157-2017·2016-10-26

    Windstone Medical Brow Pack Kits Recalled for Sterility Compromise

    Windstone Medical Packaging is recalling Brow Pack kits because they may contain defective gloves that compromise sterility.

    Product
    Brow Pack, Kit part number PSS1785(A, PSS1785(B, and PSS1785(C. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0162-2017·2016-10-26

    Windstone Medical Recalls Cath Packs Due to Potential Sterility Compromise

    Windstone Medical Packaging is recalling 246 Cath Pack kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Cath Pack, kit number AMS4283 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0240-2017·2016-10-26

    Windstone Medical Recalls Minor Lithotomy Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 114 Minor Lithotomy Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Minor Lithotomy Pack, Kit number 002650-7 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0149-2017·2016-10-26

    Union Bagel Shop Recalls Bagels for Undeclared Wheat

    Union Bagel Shop is recalling bagels sold in Grande, Oregon, due to undeclared wheat, a major food allergen.

    Product
    Package contains a business card for "***BAGEL SHOP***" "***Pretzel Salt: Flour, Filtered Water, Organic Shortening, Olive Oil, Malt, Sugar, Sea Salt, Yeast, Pretzel Salt.***" 2 bagels per package - plastic bag with twist tie.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0152-2017·2016-10-26

    Windstone Medical Recalls Bayview Breast Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling Bayview Breast Packs because disposable gloves in the kits may contain splits or holes that compromise sterility.

    Product
    Bayview Breast Pack, Kit part numbers 009080-1 and 009080-2 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0189-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Sterility Compromise in Surgical Kits

    The FDA is recalling Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES found in Windstone Medical Packaging facial plastic kits because the gloves may contain splits or holes that compromise sterility.

    Product
    Facial Plastic Pack, Kit numbers AMS2533, AMS2533(A, and AMS3327 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0159-2017·2016-10-26

    Union Bagel Shop Jalapeno Bread Recalled for Undeclared Allergens

    Union Bagel Shop is recalling Jalapeno Bread for containing undeclared wheat and milk. The product was sold at one retail store in Grande, Oregon.

    Product
    Package contains a business card for "***BAGEL SHOP***" "***JALAPENO BREAD *** Filtered Water,Sea Salt, Olive Oil, Sugar, Flour, Yeast, Butter & Dried Jalapenos***" plastic bag with twist tie.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0142-2017·2016-10-26

    Kabobs Recalls Mini Vegetable Springrolls Due to E. coli O121 Contamination

    Kabobs Inc is recalling Mini Vegetable Springrolls because they were manufactured with flour contaminated with E. coli O121.

    Product
    MINI VEGETABLE SPRINGROLL, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0267-2017·2016-10-26

    Windstone Medical Packaging Recalls Surgical Set Up Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 16 surgical Set Up Packs because they may contain defective gloves that compromise sterility.

    Product
    Set Up Pack, Kit number PSS3574(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0211-2017·2016-10-26

    Windstone Medical Knee Arthroscopy Kits Recalled for Sterility Compromise

    Windstone Medical Packaging is recalling knee arthroscopy kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Knee Arthroscopy Pack AMS2610, AMS2610(A, AMS3236, PSS2188(A, and PSS2208(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0237-2017·2016-10-26

    Windstone Medical Mammoplasty Kits Recalled for Potential Sterility Compromise

    Windstone Medical Packaging is recalling 140 Mammoplasty Kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Mammoplasty Pack, Kit number AMS2535 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0249-2017·2016-10-26

    Windstone Medical Packaging Recalls Surgical Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 280 Newport Coast Basic Pack surgical kits because the disposable gloves inside may have splits or holes that compromise sterility.

    Product
    Newport Coast Basic Pack, Kit number 007484-1 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0198-2017·2016-10-26

    QualiTech Recalls Cheddar Cheese Due to Potential E. coli O121 Presence

    QualiTech is recalling FE Cheddar Cheese because a supplier reported the potential presence of E. coli O121 bacteria.

    Product
    FE Cheddar Cheese, Product Code 22518. 50 lb corrugated case with polyliner. Manufactured by: QualiTech, 318 Hazeltine Drive, Chaska, MN 55318 USA
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-0122-2017·2016-10-26

    Synergetics Recalls 25 Gauge VersaVit 2.0 Vitrectomy Cutters

    Synergetics Inc is recalling 25 gauge VersaVit 2.0 Vitrectomy Cutters because they may not operate within the correct pressure pulse specifications.

    Product
    25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch configuration.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0204-2017·2016-10-26

    Medtronic Disposable Surgical Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.

    Product
    Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS3847, AMS4213, AMS4311, PSS1843(A, PSS2153(B, PSS2187(B, PSS2351, and PSS3073. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0160-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility.

    Product
    C-Tray Pack, Kit number PSS2707and PSS2707(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0153-2017·2016-10-26

    Union Bagel Shop Recalls Jalapeno Cheddar Bagels for Undeclared Allergens

    Union Bagel Shop is recalling Jalapeno Cheddar bagels sold in Oregon due to undeclared wheat and milk ingredients.

    Product
    Package contains a business card for "***BAGEL SHOP***" "***Jalapeno Cheddar: Flour, Filtered Water, Organic Shortening, Olive Oil, Malt, Sugar, Sea Salt, Yeast, Dried Jalapeno, Organic Cheddar Cheese Powder, Cheddar Cheese.***" 2 bagels per package - plastic bag with twis
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0158-2017·2016-10-26

    Union Bagel Shop Recalls Cinnamon Raisin Bagels for Undeclared Allergens

    Union Bagel Shop is recalling cinnamon raisin bagels sold in Oregon due to undeclared wheat and milk ingredients.

    Product
    Package contains a business card for "***BAGEL SHOP***" "***CINNAMON RAISIN*** Filtered Water, Sea Salt, Olive Oil, Sugar, Flour, Yeast, Butter Cinnamon & Raisins***" plastic bag with twist tie.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0269-2017·2016-10-26

    Windstone Medical Recalls Shoulder Arthroscopy Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 1,124 shoulder arthroscopy kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Shoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(A, AMS2609, PSS2209(A, and PSS2209(B. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0124-2017·2016-10-26

    X Spine Systems Recalls Calix P PEEK Lumbar System PLIF Rasps

    X Spine Systems Inc is recalling 182 units of Calix P PEEK Lumbar System PLIF Rasps because the tools may detach and become lodged in the surgical site.

    Product
    Calix P PEEK Lumbar System, PLIF Rasp
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Food)·F-0201-2017·2016-10-26

    QualiTech Recalls FE Rainbow Blend 714 Due to E. coli O121 Risk

    QualiTech is recalling FE Rainbow Blend 714 because a supplier notified them of potential E. coli O121 bacteria contamination.

    Product
    FE Rainbow Blend 714, Product Code 22714. 50 lb corrugated case with polyliner. Manufactured by: QualiTech, 318 Hazeltine Drive, Chaska, MN 55318 USA
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-0195-2017·2016-10-26

    Windstone Medical Packaging Recalls General Pack II Surgical Kits

    Windstone Medical Packaging is recalling General Pack II surgical kits because the Medtronic gloves included may contain splits or holes that compromise sterility.

    Product
    General Pack II, Kit number CMP1812(B convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0277-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.

    Product
    Total Knee Pack, Kit number AMS4010(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0295-2017·2016-10-26

    Ethicon Endo-Surgery Recalls Endoscopic Articulating Linear Cutters Due to Gear Failure

    Ethicon Endo-Surgery Inc is recalling 105 Endoscopic Articulating Linear Cutters because a pinion gear could fail, potentially causing a sharps injury to healthcare professionals.

    Product
    Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM. The ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutter has application in general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-0222-2017·2016-10-26

    Windstone Medical Recalls Laparotomy Packs Due to Sterility Compromise

    Windstone Medical Packaging is recalling 1,528 laparotomy packs because disposable gloves inside may have splits or holes that compromise sterility.

    Product
    Laparotomy Pack, Kit number 006047-2, 006268-8, 006268-9, AMS4418, PSS2154, PSS2190, and PSS2190(A. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0156-2017·2016-10-26

    Windstone Medical Breast Pack Kits Recalled for Sterility Compromise

    Windstone Medical Packaging is recalling 505 breast pack kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Breast Pack, Kit part number AMS3238, AMS3238(A, AMS3691, AMS4419, PSS1541, PSS1784, PSS1784(A, PSS1784(B, PSS2272, and PSS2272(A. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0212-2017·2016-10-26

    Windstone Medical Knee Packs Recalled for Potential Sterility Compromise

    Windstone Medical is recalling 30 Knee Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Knee Pack, Kit number AMS4211 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0252-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.

    Product
    Open Procedure Pack II, Kit number RMS1740(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0194-2017·2016-10-26

    Windstone Medical Recalls General Surgery Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 1,596 General Pack I surgery kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    General Pack I, Kit number CMP1811(B convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0004-2017·2016-10-26

    Leonhard Lang Recalls Skintact Defibrillation Electrodes Due to Connection Delay

    Leonhard Lang is recalling Skintact DF29N defibrillation electrodes because they may not connect to Welch Allyn AED 10 devices promptly, delaying life-saving treatment.

    Product
    Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0195-2017·2016-10-26

    QualiTech Recalls Green Bell Peppers Due to Potential E. coli O121 Contamination

    QualiTech, Inc. is recalling 300 lbs of green bell peppers due to potential E. coli O121 contamination. The product was distributed to multiple US states and Canada.

    Product
    FE Green Bell Pepper 338, Product Code 22338. 50 lb corrugated case with polyliner. Manufactured by: QualiTech, 318 Hazeltine Drive, Chaska, MN 55318 USA
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-0266-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.

    Product
    Robotic Pack, Kit number AMS4389 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0193-2017·2016-10-26

    Windstone Medical Recalls General Surgery Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 1,596 general surgery kits because the disposable gloves inside may contain splits or holes that compromise sterility.

    Product
    General Pack, Kit numbers: AMS2334, AMS2334(A, AMS2967, AMS2967(A, AMS3239, AMS3709, and AMS3709(A. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0183-2017·2016-10-26

    Windstone Medical Extremity Kits Recalled for Potential Sterility Compromise

    Windstone Medical is recalling 3,829 Extremity Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Extremity Pack, Kit number AMS2726, AMS2937, AMS3240, PSS1381(A PSS1381(B, PSS1798(A, PSS1842(A, and PSS2706 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0137-2017·2016-10-26

    Kabobs Coconut Shrimp Recalled Due to E. coli O121 Contaminated Flour

    Kabobs Inc is recalling Coconut Shrimp because it was manufactured with flour recalled for E. coli O121 contamination.

    Product
    COCONUT SHRIMP, 100 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0251-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.

    Product
    Ocular Plastic Pack, Kit number AMS3868 and AMS3868(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0219-2017·2016-10-26

    Windstone Medical Recalls Laparoscopic Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 1,290 laparoscopic kits because the disposable gloves included may have splits or holes that compromise sterility.

    Product
    Laparoscopic Pack, Kit number AMS2499 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0149-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.

    Product
    Basic Tray, Kit part numbers AMS1199(A and PSS1559(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0275-2017·2016-10-26

    Windstone Medical Recalls Total Hip Packs Due to Sterility Compromise

    Windstone Medical Packaging is recalling 54 Total Hip Packs because disposable gloves in the kits may contain splits or holes that compromise sterility.

    Product
    Total Hip Pack, Kit number PSS2956 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0288-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.

    Product
    Port Access Kit, Kit number PSS1505(C convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0202-2017·2016-10-26

    Windstone Medical GYN-Laparoscopy Tray Recalled for Sterility Compromise

    Windstone Medical Packaging is recalling GYN-Laparoscopy Tray kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    GYN-Laparoscopy Tray AMS1196(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0159-2017·2016-10-26

    Windstone C-Section Kits Recalled Due to Potential Glove Splits or Holes

    Windstone Medical Packaging is recalling C-Section kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    C-Section Pack, Kit number 002643-10, 002643-9, and AMS4449 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0146-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in custom surgical kits.

    Product
    Basic Kit, Part numbers BP1110(C and CMP1109(A. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0220-2017·2016-10-26

    Windstone Medical Recalls Laparoscopy Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 184 laparoscopy kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Laparoscopy Pack, Kit number AMS2537 and AMS2537(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0139-2017·2016-10-26

    Kabobs Crab Cakes Recalled Due to E. coli O121 Contamination

    Kabobs Inc is recalling crab cakes prepared with flour contaminated with E. coli O121. The product was distributed to multiple states.

    Product
    CRAB CAKES, 1.25 OZ, 112 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0292-2017·2016-10-26

    Philips IntelliVue MX40 Patient Monitor Recall for ECG Alarm Configuration Issue

    Philips is recalling 1,824 IntelliVue MX40 patient monitors worldwide because a configuration setting may disable ECG alarms.

    Product
    Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping (2.4GHz) Product Number: 865351 Worldwide Except USA Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 Exchange part: 453564262531 453564262551 4535
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0148-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in surgical kits.

    Product
    Basic Setup Pack, kit part number AMS1787(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0125-2017·2016-10-26

    Kabobs Recalls Mini Mushroom Quiche Due to E. coli O121 Contamination

    Kabobs Inc is recalling Mini Mushroom Quiche because it was manufactured with flour contaminated with E. coli O121.

    Product
    MINI MUSHROOM QUICHE, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0169-2017·2016-10-26

    Windstone Medical Recalls D & C Kits Due to Sterility Compromise

    Windstone Medical Packaging is recalling 592 D & C Kits because disposable gloves in the kits may contain splits or holes that compromise sterility.

    Product
    D & C Kit, Kit number CMP1466 and CMP1466(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0171-2017·2016-10-26

    Gourmet Foods Recalls Breaded Artichoke Hearts Due to E. coli Risk

    Gourmet Foods, Inc. is recalling breaded artichoke hearts because they were made with flour recalled for potential E. coli contamination.

    Product
    Artichoke Heart with Boursin Mousse Breaded Pack Size: 200 ea. per case UPC: 11784-03 Keep Frozen: Gourmet Foods, Hayward, CA
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0175-2017·2016-10-26

    Windstone Medical Recalls Dr. Casey Pack Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 48 Dr. Casey Pack kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Dr. Casey Pack, kit number AMS4313 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0217-2017·2016-10-26

    Windstone Medical recalls surgical kits with defective disposable gloves

    Windstone Medical Packaging is recalling 117 surgical kits because the included Medtronic disposable gloves may have splits or holes that compromise sterility.

    Product
    Lap/Hyst Pack, Kit number AMS2539 and AMS2539(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0163-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.

    Product
    Custom Arterial Pack, kit number RMS1712(F convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0281-2017·2016-10-26

    Windstone Medical Packaging Recalls Upper Torso Surgical Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 546 Upper Torso Tray kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Upper Torso Tray, Kit number PSS1554(B convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0193-2017·2016-10-26

    QualiTech Recalls FE Bacon 286 Due to Potential E. coli O121 Presence

    QualiTech is recalling 400 lbs of FE Bacon 286 because a supplier reported the potential presence of E. coli O121 bacteria.

    Product
    FE Bacon 286, Product Code 22286. 50 lb corrugated case with polyliner. Manufactured by: QualiTech, 318 Hazeltine Drive, Chaska, MN 55318 USA
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-0170-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.

    Product
    D&C/Cysto Pack, Kit number PSS3257, PSS3257(A, and PSS3257(B convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0140-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic is recalling COVER LIGHT HANDLE DISPOSABLE GLOVES because splits or holes may compromise sterility. The gloves are part of custom surgical kits.

    Product
    Abdominoplasty Tray, there are two Kit part numbers: PSS1782 and PSS1782(A. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0166-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in custom surgical kits.

    Product
    Custom Pack - with Introducer Kit, Kit number TVS4011NI(K and TVS4011NI(L convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0154-2017·2016-10-26

    Union Bagel Shop Recalls Italian Bagels for Undeclared Wheat

    Union Bagel Shop is recalling Italian bagels sold in Grande, Oregon, due to undeclared wheat. The voluntary recall was initiated by the firm.

    Product
    Package contains a business card for "***BAGEL SHOP***" "***Italian: Flour, Filtered Water, Organic Shortening, Olive Oil, Malt, Sugar, Sea Salt, Yeast, Organic Marinara Sauce, Oregano.***" 2 bagels per package - plastic bag with twist tie.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0287-2017·2016-10-26

    Windstone Medical Packaging Recalls Mohs Closer Packs Due to Sterility Risk

    Windstone Medical Packaging is recalling 340 Mohs Closer Packs because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Mohs Closer Pack, kit number PSS1827(A, PSS1827(B, and PSS1827(C convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0162-2017·2016-10-26

    Union Bagel Shop Cowboy Cookies Recalled for Undeclared Allergens

    Union Bagel Shop is recalling Cowboy Cookies In-a-Jar because the packaging fails to declare wheat, milk, and soy allergens.

    Product
    Package contains a business card for "***BAGEL SHOP***" "***Cowboy Cookies In-a- Jar***INGREDIENTS: FLOUR, ROLLED OATS, BROWN SUGAR, BAKING POWDER, SALT, SUGAR, M & M's***" This information was hand written on a business card, no separate ingredient statement.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0178-2017·2016-10-26

    Windstone Medical Recalls Dr. Landi EVLT Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 2,048 Dr. Landi EVLT Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Dr. Landi EVLT Pack, Kit numbers AMS1483(A, AMS1483(B, and AMS1483(C convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0161-2017·2016-10-26

    Union Bagel Shop Recalls 10-Grain Bread for Undeclared Milk

    Union Bagel Shop is recalling 10-Grain Bread sold in Grande, Oregon, because the product contains butter, an undeclared milk ingredient.

    Product
    Package contains a business card for "***BAGEL SHOP***" "***10-GRAIN BREAD***Filtered Water, Sea Salt, Olive Oil, Sugar, Flour, Whole Wheat Flour, 10-Grain: Milled Wheat, Rye, Oats, Oat Bran, Corn, Millet, Triticale, Brown Rice, Flax Seed, Barley, Soya Beans, Yeast, & Butter*
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0091-2017·2016-10-26

    Ortho-Clinical VITROS Chemistry TRIG Slides Recalled Due to NAC Interference

    Ortho-Clinical Diagnostics is recalling VITROS TRIG Slides because N-Acetylcysteine (NAC) can interfere with the assay results.

    Product
    VITROS Chemistry Products TRIG Slides, REF/Product Codes 133 6544 (300 slides per sales unit) and 832 9930 (90 slides per sales unit), Unique Device Identifier Nos. 10758750008889 and 10758750004768, Rx ONLY, IVD --- For in vitro diagnostic use only. VITROS Chemistry Products T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0272-2017·2016-10-26

    Windstone Medical Packaging Recalls Student Pack-NS Surgical Kits

    Windstone Medical Packaging is recalling Student Pack-NS surgical kits because the Medtronic gloves included may have splits or holes that compromise sterility.

    Product
    Student Pack-NS, Kit number PSS2788 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0203-2017·2016-10-26

    Windstone Medical Recalls Hall SAP Surgical Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 30 Hall SAP surgical kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Hall SAP, Kit number SRK1031(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0163-2017·2016-10-26

    Fred Meyer Recalls Boar's Head Superfood Wraps for Undeclared Allergens

    Fred Meyer is recalling Boar's Head To Go Superfood Wraps sold in deli departments due to undeclared milk, soybeans, wheat, and cashews.

    Product
    Product is refrigerated Boars Head To Go (BTG) Superfood Wrap, sold at deli department. The wraps are made in store and the weight varies and they are sold as one each (wrap). The UPC is 41573 11053.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0202-2017·2016-10-26

    QualiTech Recalls Green Bell Peppers Due to E. coli O121 Risk

    QualiTech, Inc. is recalling specific lots of green bell peppers due to a potential presence of E. coli O121 bacteria identified by a supplier.

    Product
    FE Green Bell Pepper, Product Code 22733. 50 lb corrugated case with polyliner. Manufactured by: QualiTech, 318 Hazeltine Drive, Chaska, MN 55318 USA
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-0135-2017·2016-10-26

    Kabobs Wild Mushroom in Phyllo Recalled Due to E. coli O121 Contamination

    Kabobs Inc is recalling Wild Mushroom in Phyllo because it was made with flour contaminated with E. coli O121.

    Product
    WILD MUSHROOM IN PHYLLO, 100 CT and 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0184-2017·2016-10-26

    Windstone Medical Packaging Recalls Extremity Pack-N Brunswick Kits

    Windstone Medical Packaging is recalling 290 units of Extremity Pack-N Brunswick kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Extremity Pack-N Brunswick, kit number PSS1866(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0243-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in surgical kits.

    Product
    Minor Tray AMS2685 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0144-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.

    Product
    Basic Extended Pack, kit part number AMS4421. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0291-2017·2016-10-26

    Philips IntelliVue MX40 Patient Monitor Recall for ECG Alarm Configuration Issue

    Philips is recalling IntelliVue MX40 patient monitors because a configuration setting may disable ECG alarms. The issue affects 9,804 units distributed in the US and 35 other countries.

    Product
    Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping (1.4GHz) Product Number: 865350 Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 USA only SW Revisions: B.05.28, B.05.29, and B.05.32 Indicated f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0053-2017·2016-10-26

    Vascular Solutions Recalls Twin-Pass Catheters Due to Manufacturing Material

    Vascular Solutions is recalling Twin-Pass dual access catheters because excess manufacturing material may remain at the tip or in the distal lumen.

    Product
    Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 5230. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or peripheral vasculature. The Twin-Pass catheter (Models 5200 and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0131-2017·2016-10-26

    ConMed Recalls CORE Suction Irrigation Handpiece Y-Tubing Sets

    ConMed is recalling CORE Suction Irrigation Handpiece Y-Tubing sets because a crease in the packaging seal may compromise sterility.

    Product
    CORE¿ Suction Irrigation Handpiece Y-Tubing set, with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8200 The CORE Suction/Irrigation Y Tubing Set with Trumpet Valves (CD8200) is indicated for use in gynecological and abdominal surgery for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0173-2017·2016-10-26

    Gourmet Foods Recalls Breaded Cheese Ravioli Due to E. coli Risk

    Gourmet Foods, Inc. is recalling Breaded Cheese Ravioli because it was manufactured with flour recalled by General Mills for potential E. coli contamination.

    Product
    Breaded Cheese Ravioli Pack Size: 1 oz. ea. 15 lb. per case UPC: 18890-03 Keep Frozen: Gourmet Foods, Hayward, CA
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0054-2017·2016-10-26

    Vascular Solutions Recalls Twin-Pass RX Dual Access Catheters Due to Manufacturing Defect

    Vascular Solutions is recalling Twin-Pass RX Dual Access Catheters because excess manufacturing material may remain at the tip or within the distal lumen.

    Product
    Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or peripheral vasculature. The Twin-Pass catheter (Models 5200 and 5230) consist
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0296-2017·2016-10-26

    Ethicon Endo-Surgery Recalls Endoscopic Articulating Linear Cutters

    Ethicon Endo-Surgery Inc is recalling 213 Endoscopic Articulating Linear Cutters because a pinion gear failure could interrupt the firing stroke and expose healthcare professionals to sharps injuries.

    Product
    Endoscopic Articulating Linear Cutter, 38ATW35. VASCULAR/THIN 35MM The ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutter has application in general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-0223-2017·2016-10-26

    Windstone Medical Recalls Laparotomy Kits Due to Potential Sterility Compromise

    Windstone Medical Packaging is recalling 32 Laparotomy Tray kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Laparotomy Tray, Kit number PSS1538 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0256-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.

    Product
    Pacemaker Kit, Kit number AMS4281 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide

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