The Recall Desk

Archive

June 2013 recalls

533 recalls were announced in June 2013.

What the numbers show

Critical
24
Severe
199
High
169
Moderate
108
Low
33

Of the 533 recalls this month scored against our rubric, 5% are Critical, 37% are Severe.

Which agencies issued them

501–533 of 533

  • ModerateFDA (Devices)·Z-1407-2013·2013-06-05

    Alpine Biomed Recalls Natus Dantec KEYPOINT.NET Software Due to Bug

    Alpine Biomed Aps is recalling Natus neurology Dantec KEYPOINT.NET version 2.20 software due to a software bug. The recall affects 871 installed licenses distributed worldwide.

    Product
    Natus neurology Dantec KEYPOINT.NET 2.20. Catalog/Part Numbers: 9031A070103, 9031A006502, 9033A071103, 9033A072102, 9031A070102, 9033A007402, 9033A071102, 9033A072103, 9033A0701, 9033A0711HA, 9033A071101, 9031A070101, 9031A006401, 9031A006501, 9033A004701, 9031A0032…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1377-2013·2013-06-05

    Anspach Effort 3mm Diamond Ball Burrs Recalled for Grit Size Defect

    The Anspach Effort, Inc. is recalling 1,827 3mm Diamond Ball burrs because three batches may have diamond grit larger than intended.

    Product
    ***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1396-2013·2013-06-05

    Stryker Orthobiologics Aliquot Reamer Recalled for Catheter Breakage

    Stryker Orthobiologics is recalling 7 units of the Aliquot Reamer, 6" (Part Number 2110-0504) because the catheter may break during removal from the needle.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 6", Part Number 2110-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1411-2013·2013-06-05

    Spinal Solutions Recalls Set Screws Due to Missing Surgical Instructions

    Spinal Solutions is recalling 106 Set Screws (Item #BG3010) because directions for use and surgical techniques were not provided to every physician.

    Product
    Set Screw, Item #BG3010 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1423-2013·2013-06-05

    Becton Dickinson Recalls BBL DrySlide Oxidase Kits Due to Packaging Error

    Becton Dickinson is recalling BBL DrySlide Oxidase Kits because they were placed in incorrect packaging for distribution to laboratories.

    Product
    BBL DrySlide Oxidase Kit, catalog number 231746 Product Usage: Presumptive diagnostic aid for gram-negative bacteria.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1390-2013·2013-06-05

    Stryker Orthobiologics Aliquot Delivery System Recalled for Catheter Breakage

    Stryker Orthobiologics is recalling 155 units of the Aliquot Syringe Delivery System because the catheter may break during removal from the needle.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Syringe Delivery System, 6", Part Number 2090-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1400-2013·2013-06-05

    Beckman Coulter Recalls Lactate Reagent Due to Error Messages

    Beckman Coulter is recalling Lactate Reagent Lot M206209 because it may fail to report numerical values for high lactate concentrations.

    Product
    Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part Number: A95550 Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX System(s), UniCel DxC 600/800 System(s) and Synchron Systems Multi Calibrator, is intended for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1428-2013·2013-06-05

    Intuitive Surgical Recalls da Vinci Flush Ports for Labeling Clarification

    Intuitive Surgical is recalling da Vinci instrument flush ports to clarify existing labeling and operating procedures.

    Product
    Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1413-2013·2013-06-05

    Spinal Solutions Recalls 50 mm Rods Due to Missing Surgical Instructions

    Spinal Solutions is recalling 55 units of 50 mm Rods because directions for use and surgical techniques were not provided to every physician.

    Product
    50 mm Rod, Item #BG1650 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1463-2013·2013-06-05

    Red Bone Alley Wasabi Sauce Recalled for Undeclared Metabisulfite

    National Food & Beverage, Inc. is recalling Red Bone Alley Wasabi Sauce due to undeclared metabisulfite. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    Red Bone Alley Restaurant Wasabi All Natural Sauce for all Seafood & Chicken, Net Wt. 12 fl oz. Distributed by: Red Bone Alley Foods, LLC, 1903 W. Palmetto Street, Florence, SC 29501. Clear Plastic (Pet) Ring Neck Round bottle with neck band with white screw top cap. 6/12oz…
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1375-2013·2013-06-05

    Intel-GE QuietCare Recall Issued for Duplicate Alert Functionality

    Intel-GE Care Innovations LLC is recalling QuietCare monitoring systems because customers reported receiving duplicate alerts. The recall affects 1,722 units distributed in the US and Great Britain.

    Product
    QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-486-2013·2013-06-05

    Nora Apothecary Recalls Methylcobalamin Injections Due to Sterility Concerns

    Nora Apothecary and Alternative Therapies, Inc. is recalling Methylcobalamin Injections due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Methylcobalamin Inj 2.5mg/ml MDV, 10 ml Subcutaneous, 90 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1382-2013·2013-06-05

    Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Missing Instructions

    Orthopedic Alliance LLC is recalling 21 loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician.

    Product
    Femoral head, standard, ¿26mm, +0mm Femoral head,medium, ¿26mm,+3mm Femoral head, long, ¿26mm, +6mm Femoral head, X-long, ¿26mm, +9mm Femoral head, ¿28mm, -3mm Femoral head, ¿28mm, +0mm Femoral head, ¿28mm, +5mm Femoral head, ¿28mm, +10mm Femoral head, ¿32mm, -3mm…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1417-2013·2013-06-05

    Spinal Solutions Recalls Copperhead IBFD Loaner Bins Due to Missing Instructions

    Spinal Solutions is recalling Copperhead IBFD loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician.

    Product
    Copperhead IBFD, Large Neutral, 6mm Copperhead IBFD, Large Neutral, 7mm Copperhead IBFD, Large Neutral, 8mm Copperhead IBFD, Large Neutral, 9mm Copperhead IBFD, Large Neutral, 10mm Copperhead IBFD, Large Neutral, 11mm Product Usage: Spinal Solutions distributes a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1386-2013·2013-06-05

    Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Missing Instructions

    Orthopedic Alliance LLC is recalling 26 loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician for every surgery.

    Product
    Ball Head, 28 Short CERAMIC Ball Head, 28 Medium CERAMIC Ball Head, 28 Long CERAMIC Ball Head, 32 Short CERAMIC Ball Head, 32 Medium CERAMIC Ball Head, 32 Long CERAMIC Ball Head, 28 Short CoCr Ball Head, 28 Medium CoCr Ball Head, 28 Long CoCr Ball Head, 28 X-Long CoCr…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1414-2013·2013-06-05

    Spinal Solutions Recalls 60 mm Rods Due to Missing Surgical Instructions

    Spinal Solutions is recalling 72 units of 60 mm Rods because directions for use and surgical techniques were not provided to every physician.

    Product
    60 mm Rod, Item #BG1660 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1412-2013·2013-06-05

    Spinal Solutions Recalls 40 mm Rods Due to Missing Surgical Instructions

    Spinal Solutions is recalling 63 units of 40 mm Rods because directions for use and surgical techniques were not provided to every physician.

    Product
    40 mm Rod, Item #BG1640 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1381-2013·2013-06-05

    Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Documentation Issues

    Orthopedic Alliance LLC is recalling 30 units of loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician.

    Product
    U2 Acetabular cup, Ti beads porous coated, ¿44mm U2 Acetabular cup, Ti beads porous coated, ¿46mm U2 Acetabular cup, Ti beads porous coated, ¿48mm U2 Acetabular cup, Ti beads porous coated, ¿50mm U2 Acetabular cup, Ti beads porous coated, ¿52mm U2 Acetabular cup, Ti beads…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1456-2013·2013-06-05

    Meijer Fruit Cups Recalled for Nutrition Labeling Errors

    Meijer Distribution is recalling specific fruit cups because the serving size was updated but the nutrition facts were not.

    Product
    Meijer Mandarin Oranges in Fruit Juice 8oz cup
    Category
    Food
    Distribution
    5 states
  • LowFDA (Drugs)·D-498-2013·2013-06-05

    Aurobindo Recalls Lisinopril Tablets Due to Labeling Error

    Aurobindo Pharma USA Inc is recalling specific lots of Lisinopril 30 mg tablets because the label displays the incorrect strength on the side panel.

    Product
    LISINOPRIL — LISINOPRIL (LISINOPRIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1429-2013·2013-06-05

    Intuitive Surgical da Vinci Si Surgeon Console Labeling Clarification

    Intuitive Surgical is clarifying labeling and operating procedures for the da Vinci Si Surgeon Console to ensure accurate control of endoscopic instruments.

    Product
    da Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1426-2013·2013-06-05

    Intuitive Surgical Recalls Unapproved da Vinci Thyroidectomy Promotional Literature

    Intuitive Surgical is recalling promotional literature for the da Vinci Surgical System's thyroidectomy indication because the use was not approved with a 510(k) change.

    Product
    Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroidectomy offers a minimally invasive surgery for both partial and total thyroidectomy procedures, including endoscopic and video assisted procedure that are preferable to conventional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1455-2013·2013-06-05

    Meijer Fruit Cups Recalled for Nutrition Labeling Errors

    Meijer Distribution is recalling diced pears, peaches, and mandarin oranges in fruit juice 8 oz cups because the nutrition facts panel reflects the wrong serving size.

    Product
    Meijer Diced Peaches in Fruit Juice 8oz cup
    Category
    Food
    Distribution
    5 states
  • LowFDA (Food)·F-1454-2013·2013-06-05

    Meijer Diced Pears Recalled for Nutrition Labeling Error

    Meijer Distribution is recalling Diced Pears in Fruit Juice 8oz cups because the nutrition facts label reflects the wrong serving size.

    Product
    Meijer Diced Pears in Fruit Juice 8oz cup
    Category
    Food
    Distribution
    5 states
  • SevereNHTSA·13V233000·2013-06-04

    Chrysler Recalls Jeep Compass and Patriot for Airbag Software Error

    Chrysler is recalling 2010-2012 Jeep Compass and Patriot vehicles because a software error may prevent side airbags and seatbelt pre-tensioners from deploying in a crash.

    Product
    JEEP — JEEP COMPASS, PATRIOT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V234000·2013-06-04

    Chrysler Recalls 2012-2013 Jeep Wranglers for Transmission Fluid Leak Risk

    Chrysler is recalling 2012-2013 Jeep Wranglers with 3.6L engines and automatic transmissions because a power steering line may wear a hole in the transmission oil cooler line, causing fluid loss.

    Product
    JEEP — JEEP WRANGLER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V239000·2013-06-04

    Chrysler Recalls 2012 Dodge Ram Trucks Due to Front Axle Fracture Risk

    Chrysler is recalling 5,622 model year 2012 Dodge Ram 4500 and 5500 trucks because a welding defect may cause the front drive shaft to fracture, potentially leading to a loss of motive power and increased crash risk.

    Product
    DODGE — DODGE RAM 5500, RAM 4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V240000·2013-06-04

    Chrysler Recalls 2013 Ram Trucks for Headlight Shutter Defect

    Chrysler is recalling 2013 Ram 2500 and 3500 trucks because headlamp shutters may malfunction in high-beam mode, potentially blinding oncoming traffic.

    Product
    RAM — RAM 3500, 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V236000·2013-06-04

    Mercedes-Benz Recalls 2013 SLK250 and SLK350 for Airbag System Defect

    Mercedes-Benz is recalling 2013 SLK250 and SLK350 vehicles because the occupant classification system may fail to detect light passengers, potentially deactivating the airbag.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ, MERCEDES-BENz SLK350, SLK250
    Category
    Vehicle
    Distribution
    Distributed nationwide

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