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.

101–200 of 1035

  • 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 (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 (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-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-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 (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
  • HighFDA (Devices)·Z-0250-2017·2016-10-26

    Windstone Medical Recalls OB/GYN Kits Due to Potential Sterility Compromise

    Windstone Medical Packaging is recalling 18 OB/GYN kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    OB/GYN Pack, Kit number AMS2038 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0148-2017·2016-10-26

    Union Bagel Shop Recalls Cinnamon Raisin Bagels Due to Undeclared Wheat

    Union Bagel Shop is recalling Cinnamon Raisin Bagels because the packaging fails to declare wheat as an ingredient. The products were sold at one retail store in Grande, Oregon.

    Product
    Package contains a business card for "***BAGEL SHOP***" "***Cinnamon Raisin: Flour, Filtered Water, Organic Shortening, Olive Oil, Malt, Sea Salt, Sugar, Yeast, Cinnamon, Raisin***" 2 bagels per package - plastic bag with twist tie.
    Category
    Food
    Distribution
    0 states
  • 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 (Food)·F-0172-2017·2016-10-26

    Gourmet Foods Recalls Strudel Wild Mushroom Due to E. coli Risk

    Gourmet Foods, Inc. is recalling Strudel Wild Mushroom products because they were manufactured with flour recalled by General Mills for potential E. coli contamination.

    Product
    Strudel Wild Mushroom Pack Size: 240 ea. per case UPC: 17338-03 Keep Frozen: Gourmet Foods, Hayward, CA
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0139-2017·2016-10-26

    Windstone Medical Recalls Abdominoplasty Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 15 Abdominoplasty Packs because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Abdominoplasty Pack, Kit number AMS3326 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0198-2017·2016-10-26

    Windstone Medical Recalls General Surgery Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 168 General Surgery Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    General Surgery Pack, Kit number PSS1380(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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-0200-2017·2016-10-26

    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
    GYN Lap Pack, Kit number PSS2194(B 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
  • HighNHTSA·16V781000·2016-10-26

    GM Recalls 2016 Chevrolet Malibu for Side Air Bag Defect

    General Motors is recalling 2016 Chevrolet Malibus because the side-impact air bag fabric may tear during deployment, potentially increasing injury risk in a crash.

    Product
    CHEVROLET — CHEVROLET MALIBU
    Category
    Vehicle
    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 (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-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 (Food)·F-0203-2017·2016-10-26

    QualiTech Recalls Frozen Red Bell Peppers Due to E. coli O121 Risk

    QualiTech is recalling frozen red bell peppers due to a potential presence of E. coli O121 bacteria reported by a supplier.

    Product
    FE RedBell Pepper, Product Code 22760. 50 lb corrugated case with polyliner. Manufactured by: QualiTech, 318 Hazeltine Drive, Chaska, MN 55318 USA
    Category
    Food
    Distribution
    10 states
  • 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-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-0150-2017·2016-10-26

    FDA Recalls Windstone Medical Basin Packs Due to Sterility Compromise

    Windstone Medical Packaging is recalling 1,243 Basin Packs (kit AMS2497) because included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Basin Pack, kit number AMS2497 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0228-2017·2016-10-26

    Windstone Medical Recalls Lower Extremity Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 582 Lower Extremity Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Lower Extremity Pack, Kit number AMS1375(A, AMS2540, AMS2540(A, and AMS4669. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0126-2017·2016-10-26

    Kabobs Roasted Vegetable Tart Recalled Due to E. coli O121 Contamination

    Kabobs Inc is recalling Roasted Vegetable Tarts because they were made with flour contaminated with E. coli O121.

    Product
    ROASTED VEGETABLE, 200 CT, TART Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0234-2017·2016-10-26

    Windstone Medical Recalls Major Lithotomy Packs Due to Sterility Concerns

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

    Product
    Major Lithotomy Pack, kit number 002641-5 and 002641-6 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0226-2017·2016-10-26

    Windstone Medical Recalls Lithotomy Packs Due to Sterility Compromise

    Windstone Medical Packaging is recalling 630 Lithotomy Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Lithotomy Pack, Kit number AMS2333 and AMS2333(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0205-2017·2016-10-26

    QualiTech Recalls FE Rainbow Blend Due to Potential E. coli O121 Presence

    QualiTech, Inc. is recalling 1,400 lbs of FE Rainbow Blend because a supplier notified the company of potential E. coli O121 bacteria in the material.

    Product
    FE Rainbow Blend, Product Code 22795. 50 lb corrugated case with polyliner. Manufactured by: QualiTech, 318 Hazeltine Drive, Chaska, MN 55318 USA
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-0160-2017·2016-10-26

    Union Bagel Shop Recalls Cinnamon Swirl Bagels for Undeclared Allergens

    Union Bagel Shop is recalling Cinnamon Swirl bagels due to undeclared wheat and milk ingredients. The products were distributed to one retail store in Grande, Oregon.

    Product
    Package contains a business card for "***BAGEL SHOP***" "***CINNAMON SWIRL***Filtered Water, Sea Salt, Olive Oil, Sugar, Flour, Yeast, Butter & Cinnamon***" plastic bag with twist tie.
    Category
    Food
    Distribution
    0 states
  • 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-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-0135-2017·2016-10-26

    ConMed CORE Trumpet Handpiece Recalled for Potential Sterility Compromise

    ConMed is recalling CORE Trumpet Handpieces because packaging creases may create open channels that compromise sterility.

    Product
    CORE¿ Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0232-2017·2016-10-26

    Windstone Medical Packaging Recalls Major Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 175 Major Kits (PHC1307A) because the Medtronic gloves inside may have splits or holes that compromise sterility.

    Product
    Major Kit, Kit number PHC1307(A 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-0278-2017·2016-10-26

    Windstone Medical Recalls Transvaginal Packs Due to Potential Sterility Compromise

    Windstone Medical Packaging is recalling 1,780 Transvaginal Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Transvaginal Pack, Kit number CMP1767 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0141-2017·2016-10-26

    Kabobs Vegetable Springrolls Recalled Due to E. coli O121 Contamination

    Kabobs Inc is recalling Vegetable Springrolls because they were made with flour contaminated with E. coli O121. The product was distributed to multiple states.

    Product
    VEGETABLE SPRINGROLL, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0206-2017·2016-10-26

    Windstone Medical Head and Neck Surgical Kits Recalled for Sterility Risk

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

    Product
    Head and Neck Pack, kit numbers AMS1373(A, AMS1869, AMS2534, and AMS2534(A. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0241-2017·2016-10-26

    Windstone Medical Recalls Minor Ortho Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling Minor Ortho Packs because disposable gloves in the kits may have splits or holes that compromise sterility.

    Product
    Minor Ortho Pack, Kit number 002646-12 and 002646-13 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0225-2017·2016-10-26

    Windstone Medical Liposuction Kits Recalled for Potential Sterility Compromise

    Windstone Medical Packaging is recalling 20 liposuction kits because the disposable gloves included may have splits or holes that compromise sterility.

    Product
    Liposuction Pack, Kit number AMS3323 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0209-2017·2016-10-26

    Windstone Medical Recalls HSG Packs Due to Potential Sterility Compromise

    Windstone Medical Packaging is recalling 360 HSG Packs because the Medtronic gloves included in the kits may contain splits or holes that compromise sterility.

    Product
    HSG Pack, Kit number PSS3287 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0208-2017·2016-10-26

    Windstone Medical Recalls Hernia Packs With Defective Gloves

    Windstone Medical Packaging is recalling 765 Hernia Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Hernia Pack, Kit number AMS1519 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0239-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Sterility Compromise in Surgical Kits

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

    Product
    Minor Lap Pack, Kit number AMS2624 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0236-2017·2016-10-26

    Windstone Medical Packaging Recalls Surgical Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 64 surgical kits because Medtronic gloves inside may have splits or holes, compromising sterility.

    Product
    Major Pack, Kit Number PSS3516 and PSS3516(A 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-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-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-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 (Devices)·Z-0164-2017·2016-10-26

    Windstone Medical Recalls Custom Breast Augmentation Kits Due to Sterility Risk

    Windstone Medical Packaging is recalling 546 custom breast augmentation kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Custom Breast Augmentation Pack, Kit number PSS2455(B, PSS2455(C, PSS2455(D convenience custom kits used for general surgery in hospital operating room
    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-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-0121-2017·2016-10-26

    Synergetics VersaVit 2.0 Procedure Packs Recalled for Pressure Defect

    Synergetics Inc is recalling 255 units of 25 gauge VersaVit 2.0 Procedure Packs because the vitrectomy cutters are not operating within the correct pressure pulse specifications.

    Product
    25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Product/Part Number 70025SP, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0270-2017·2016-10-26

    Windstone Medical Shoulder Packs Recalled for Potential Sterility Compromise

    Windstone Medical Packaging is recalling 3,104 shoulder packs used in general surgery because the disposable gloves included in the kits may contain splits or holes that compromise sterility.

    Product
    Shoulder Pack, Kit number AMS1372(A, AMS1372(B, AMS2335, AMS2335(A, AMS2936, AMS3638, AMS3711, AMS4212, PSS1852(A, convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0145-2017·2016-10-26

    Windstone Medical Packaging Recalls Basic Face Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 2,266 Basic Face Kits because the Medtronic gloves included may have splits or holes that compromise sterility.

    Product
    Basic Face Kit, Kit part numbers PS517A(B, PS517A(C, and PS517A(D. 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-0170-2017·2016-10-26

    Gourmet Foods Recalls Artichoke Bottom Ratatouille Due to E. coli Risk

    Gourmet Foods, Inc. is recalling Artichoke Bottom Ratatouille because it was manufactured with flour recalled by General Mills for potential E. coli contamination.

    Product
    Artichoke Bottom Ratatouille Pack Size: 240 ea. per case UPC: 18010-03 Keep Frozen: Gourmet Foods, Hayward, CA
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0201-2017·2016-10-26

    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
    GYN Pack, Kit number PSS2643 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0165-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic is recalling disposable gloves included in Windstone Medical custom surgical kits because splits or holes may compromise sterility.

    Product
    Custom Pack, Kit numbers PSS1300, PSS1471(A, PSS1771, PSS2135(A, PSS2135(B, PSS2207, PSS2412(B, PSS2798, PSS2798(A, PSS2798(B, PSS3054, PSS3463, TVS4011NI(J, TVS4028(A, and TVS4070. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0161-2017·2016-10-26

    Windstone Medical Recalls Cardiac Cath Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 138 Cardiac Cath Packs because the disposable gloves included in the kits may contain splits or holes that compromise sterility.

    Product
    Cardiac Cath Pack, kit number AMS2707 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0257-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Sterility Compromise in Custom Kits

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

    Product
    Pelviscopy/Laparoscopy Pack, Kit number PSS3342 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 (Food)·F-0155-2017·2016-10-26

    Union Bagel Shop Recalls Bacon Cheddar Bagels for Undeclared Allergens

    Union Bagel Shop is recalling Bacon Cheddar bagels due to undeclared wheat and milk ingredients. The products were distributed to one retail store in Grande, Oregon.

    Product
    Package contains a business card for "***BAGEL SHOP***" "***Bacon Cheddar: Flour, Filtered Water, Organic Shortening, Bacon Bits, Cheddar Cheese, Green Onions, Malt, Sugar, Sea Salt, Yeast..***" 2 bagels per package - plastic bag with twist tie.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0247-2017·2016-10-26

    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
    Morris Lap Pack, Kit number PSS3199 and PSS3199(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-0156-2017·2016-10-26

    Union Bagel Shop Recalls Sesame Seed Bagels Due to Undeclared Wheat

    Union Bagel Shop is recalling sesame seed bagels because the packaging fails to declare wheat as an ingredient. The product was sold at one retail store in Grande, Oregon.

    Product
    Package contains a business card for "***BAGEL SHOP***" "***Sesame Seed: Flour, Filtered Water, Organic Shortening, Olive Oil, Malt, Sugar, Sea Salt, Yeast, Organic Sesame Seeds.***" 2 bagels per package - plastic bag with twist tie.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0286-2017·2016-10-26

    Windstone Medical Recalls Laparoscopy Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 50 laparoscopy kits because the disposable gloves included may contain splits or holes that compromise sterility.

    Product
    Laparoscopy Kit, Kit number PSS1038(A and PSS1038(B convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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 (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-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-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-0173-2017·2016-10-26

    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
    Dr Bragg Vein Tray - RX, kit numbers 007912-5, 007912-6, 007912-7, 007912-8 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0280-2017·2016-10-26

    Windstone Medical Recalls Upper Extremity Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 108 Upper Extremity Packs because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Upper Extremity Pack, Kit number AMS2536 and AMS2536(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0176-2017·2016-10-26

    Gourmet Foods Recalls Shrimp Products Due to E. coli Contamination

    Gourmet Foods is recalling frozen shrimp products because they were manufactured with flour recalled by General Mills for potential E. coli contamination.

    Product
    Shrimp 21/25 Coconut Butterfly Pack Size: 200 ea. per case UPC: 23502-03 Keep Frozen: Gourmet Foods, Hayward, CA
    Category
    Food
    Distribution
    1 state
  • 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-0169-2017·2016-10-26

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

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

    Product
    Artichoke Heart Breaded with Goat and Cheddar Cheese : Pack Size: 240 ea. per case; UPC: 13014-03 Keep Frozen: Gourmet Foods, Hayward, CA
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0284-2017·2016-10-26

    Windstone Medical Packaging Recalls Virginia Custom Pack Kits Due to Sterility Concerns

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

    Product
    Virginia Custom Pack, Kit number RMS1744 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 (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-0137-2017·2016-10-26

    Merge Healthcare CADstream software recall for missing PURE filter message

    Merge Healthcare is recalling CADstream software versions prior to 5.2.9 because the PURE filter user interface message may not display, potentially leading to incorrect patient follow-up.

    Product
    CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0254-2017·2016-10-26

    Windstone Medical Recalls Ortho Minor Packs Due to Sterility Compromise

    Windstone Medical Packaging is recalling 160 Ortho Minor Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Ortho Minor Pack, Kit number AMS3710 convenience custom kits used for general surgery in hospital operating room
    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-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-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-0118-2017·2016-10-26

    Merge Healthcare Recalls CADstream Software Due to Incorrect Patient Follow-up

    Merge Healthcare is recalling CADstream software versions prior to 5.2.6 because changes to study protocols may result in incorrect patient follow-up.

    Product
    CADstream software Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tool
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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 (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 (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-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-0176-2017·2016-10-26

    Windstone Medical Recalls Dr. Fetters Hand Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 40 Dr. Fetters Hand Packs because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Dr. Fetters Hand Pack, Kit number AMS3690 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 (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 (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-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

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