The Recall Desk

Archive

July 2014 recalls

688 recalls were announced in July 2014.

What the numbers show

Critical
18
Severe
140
High
292
Moderate
204
Low
34

Of the 688 recalls this month scored against our rubric, 3% are Critical, 20% are Severe.

601–688 of 688

  • HighFDA (Devices)·Z-1871-2014·2014-07-02

    Intuitive Surgical Recalls Da Vinci Xi Endoscope Accessories Due to Visual Tint

    Intuitive Surgical is recalling 19 units of the IS4000 da Vinci Xi 0 Degree, 8mm Endoscope because an orange-yellow tint in the surgical view can make it difficult to differentiate between tissue.

    Product
    IS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope. Intuitive Surgical Inc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1814-2014·2014-07-02

    Nitinol HydroFinity Hydrophilic Guidewire Recalled for Outer Polymer Jacket Damage

    Nitinol Devices and Components is recalling HydroFinity Hydrophilic guidewires because reports indicate the outer polymer jacket may be damaged during use.

    Product
    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 260 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydrop
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1831-2014·2014-07-02

    Beckman Coulter Recalls UniCel DxH Analysis Systems for Optical Degradation

    Beckman Coulter is recalling UniCel DxH800 and DxH600 systems because optical degradation may delay reporting of specific blood cell results.

    Product
    Coulter DxH Cleaner 10L, Part No. 628023. For use on UniCel DxH Systems for components that come in contact with blood samples.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1869-2014·2014-07-02

    Elekta MOSAIQ Oncology System Recalled for Dose Calculation Error

    Elekta, Inc. is recalling MOSAIQ oncology information system software because it fails to recalculate agent volume when users change the ordering dose.

    Product
    MOSAIQ MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used where ever radiotherapy and/or chemotherapy are prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1913-2014·2014-07-02

    Anspach Custom Devices Recalled for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling Anspach Custom Devices because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF SP-4604-00***3mm Fluted Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1908-2014·2014-07-02

    Anspach Recalls 5mm Coarse Diamond Ball Devices for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling 50 units of 5mm Coarse Diamond Ball devices because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF SP-3100-00***5mm Coarse Diamond Ball, 11.5 OAL***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1887-2014·2014-07-02

    Anspach eMax 2 Modified Hand Control Recalled for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling six eMax 2 Modified Hand Control units because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF 98-0016***eMax 2 Modified Hand Control***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1866-2014·2014-07-02

    LAP Laser Pictor 3D System Recalled for Projection Splitting

    LAP of America is recalling one Laser Pictor 3D system in North Carolina because the yellow projection line can split into red and green lines, causing a 2.5mm deviation.

    Product
    LAP LASER PICTOR 3D Multi Color Laser System PICTOR 3D is a LAP laser system which uses multi projection format that defines isocenters, field and MLC contours along with a 3D patient view.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1868-2014·2014-07-02

    Integra Recalls Accell Evo3C Bone Matrix Due to Packaging Error

    Integra LifeSciences is recalling 61 units of Accell Evo3C Demineralized Bone Matrix because they were incorrectly packaged in boxes for a different product, creating a risk of improper surgical use.

    Product
    Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot Number: 132160. Product Usage: Accell Evo3c Demineralized Bone Matrix Putty is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1893-2014·2014-07-02

    Anspach Custom Medium Attachment Recalled for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling four Custom Medium Attachments because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF 98-0031***Custom Medium Attachment, with 5 mm Extended Tapered Tip***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1863-2014·2014-07-02

    Philips Recalls Ingenia 1.5T MRI Systems Due to Incorrect Hardware

    Philips Medical Systems is recalling 33 Ingenia 1.5T MRI systems because incorrect M10 nuts were installed on the rear cover set.

    Product
    Ingenia 1.5T R5, magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1883-2014·2014-07-02

    Anspach Custom Devices Recalled for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling Anspach Custom Devices because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***MA Attachment, Straight version Custom***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1917-2014·2014-07-02

    Anspach Custom Devices Recalled for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling Anspach Custom Devices because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF SP-5001-00***20 degree Angle Driver (MA-D20) - Custom***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1910-2014·2014-07-02

    Anspach Custom Devices Recalled for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling Anspach Custom Devices because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF SP-4601-00***1mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1851-2014·2014-07-02

    Teleflex Medical Recalls RUSCH LaserTube Tracheal Tubes for Missing Latex Warning

    Teleflex Medical is recalling RUSCH LaserTube tracheal tubes because the label failed to print a specific caution statement regarding natural rubber latex.

    Product
    RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Medical, Willy-Rusch, GmbH. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateNHTSA·14V406000·2014-07-02

    Ford Recalls 2014 Transit Connect Vehicles for Missing Brake Fluid Label

    Ford is recalling 2014 Transit Connect vehicles because the brake reservoir cap may lack required text identifying the correct brake fluid. This non-compliance could lead to incorrect fluid usage and brake system damage.

    Product
    FORD — FORD TRANSIT CONNECT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1895-2014·2014-07-02

    Anspach Custom eMax 2 Plus Motor Recalled for Quality System Defects

    The Anspach Effort, Inc. is recalling nine Custom eMax 2 Plus Motors because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF 98-0035***Custom eMax 2 Plus Motor with microMax Disconnect Sleeve***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1855-2014·2014-07-02

    NxStage Dialysate Sacks Recalled for Excess Aluminum Levels

    NxStage Medical is recalling dialysate sacks used in dialysis systems because they contain aluminum levels exceeding internal specifications.

    Product
    NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-302 Lactate , 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 105, Glucose (mg/dL) 100, Batch Size (liters): 60 The SAK is one of the disposables used with NxStage PureFlow SL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1879-2014·2014-07-02

    Anspach Custom MCA5-1SD Devices Recalled for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling 20 Anspach Custom MCA5-1SD devices because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***Custom MCA5-1SD with Extended Exposure***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1881-2014·2014-07-02

    Anspach eMax2 Foot Pedal Recalled for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling 21 eMax2 Lower Profile Foot Pedals because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***eMax2 Lower Profile Foot Pedal***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1918-2014·2014-07-02

    Anspach Custom Shoulder Implant Recalled for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling custom shoulder implants because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF 98-0012***Shoulder Implant 011mm Rod, 20cm Long, Custom***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1862-2014·2014-07-02

    Philips Ingenia 3.0T MRI Systems Recalled for Incorrect Nut Components

    Philips is recalling 21 Ingenia 3.0T MRI systems because some were shipped with incorrect M10 nuts instead of A4 stainless steel nuts.

    Product
    Ingenia 3.0T R5, magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1919-2014·2014-07-02

    Anspach Custom Autolube Food Guard Recalled for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling Anspach Custom Autolube Food Guard devices because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF 98-0033***Custom Autolube Food Guard***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1891-2014·2014-07-02

    Anspach Nose Cone Cover Recalled for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling Anspach Nose Cone Covers because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF 98-0024***Nose Cone Cover***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1914-2014·2014-07-02

    Anspach Recalls Arthroscopic Suture Anchor Assemblies for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling 68 arthroscopic suture anchor assemblies because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF SP-4605-00***Arthroscopic Suture Anchor assembly with Suture Threader***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1915-2014·2014-07-02

    Anspach Recalls Arthroscopic Knotless Suture Anchors for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling 100 units of Arthroscopic Knotless Suture Anchors because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***Arthroscopic Knotless Suture Anchor***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1901-2014·2014-07-02

    Anspach Custom Circular ePLUS-FP Medical Device Recall for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling Anspach Custom Circular ePLUS-FP devices because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF 98-0048***Custom Circular ePLUS-FP***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1907-2014·2014-07-02

    Anspach Recalls 130 MRI Fluted Balls Due to Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling 130 units of 4mm Fluted Balls for MRI because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF SP-3014-00***4mm Fluted Ball for MRI***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1909-2014·2014-07-02

    Anspach Custom Devices Recalled for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling Anspach Custom Devices because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF SP-3101-00***Adjustable 25 Cm Mia Attachment, Custom***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1885-2014·2014-07-02

    Anspach 2.37mm Spiral Drill Recalled for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling 10 units of the 2.37mm Spiral Drill because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF 98-0010***2.37mm Spiral Drill, for Short Attachment (Non-Sterile)***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1884-2014·2014-07-02

    Anspach Custom Devices Recalled for Quality System Manufacturing Inconsistencies

    The Anspach Effort, Inc. is recalling specific custom medical devices because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF 98-0008***7cm Medium Attachment Custom***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1880-2014·2014-07-02

    Anspach eMax Hand Control Recalled for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling three eMax Hand Control units because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF 98-0001***eMax Hand Control***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1911-2014·2014-07-02

    Anspach recalls 20 diamond ball attachments for quality system non-compliance

    The Anspach Effort, Inc. is recalling 20 units of 2mm Coarse Diamond Ball attachments because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF SP-4602-00***2mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1840-2014·2014-07-02

    Siemens LANTIS System Recall for Unvalidated Operating System Risks

    Siemens is recalling 108 LANTIS linear accelerator systems because using the software with unvalidated operating systems can cause data corruption and incorrect treatment records.

    Product
    Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1889-2014·2014-07-02

    Anspach eMax2 Console Recalled for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling eMax2 Console units because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF 98-0021***eMax2 Console with Irrigation***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1900-2014·2014-07-02

    Anspach Custom Device Speed Reducer Recalled for Quality System Defects

    The Anspach Effort, Inc. is recalling two Custom Device Speed Reducer units because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF 98-0044***Custom Device Speed Reducer with Bumper***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1846-2014·2014-07-02

    ProBeam Proton Therapy System Recalled for Treatment History Data Loss

    Varian Medical Systems is recalling ProBeam Proton Therapy Systems because the Treatment Control and Monitoring application may fail to send treatment history records to the ARIA database.

    Product
    ProBeam Proton Therapy System (HGA and HFB) Product Usage:ProBeam Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body. where radiation treatment is indicated.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1842-2014·2014-07-02

    Zimmer Recalls VerSys Hip Stems Due to Material Inspection Failures

    Zimmer, Inc. is recalling 147 VerSys Hip System stems because supplier forgings failed routine material inspections.

    Product
    VerSys¿ Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1847-2014·2014-07-02

    Baxter Abacus 3.1 Pharmacy Calculator Software Field Correction

    Baxter is correcting a software error in Abacus 3.1 that may display protein levels 1,000 times lower than actual when using Clinimix 4.25110.

    Product
    Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculations for automated compounding.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1860-2014·2014-07-02

    NxStage Dialysate Sacks Recalled for Excess Aluminum Levels

    NxStage Medical is recalling dialysate sacks used in home dialysis systems because aluminum levels exceeded internal specifications.

    Product
    NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-307 Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 105, Glucose (mg/dL) 100 Batch Size (liters) 50 The SAK is one of the disposables used with NxStage PureFlow SL Dialy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1906-2014·2014-07-02

    Anspach Recalls 113 MRI Fluted Routers for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling 113 MRI fluted routers because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***1.85mm x 16 mm Fluted Router for MRI***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1928-2014·2014-07-02

    Alere Triage BNP Calibrators Recalled Due to Mislabeling

    Alere San Diego is recalling BNP calibrators because a Level 5 bottle contains Level 4 material, causing calibration failures.

    Product
    Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems, Model No. 98202 The Alere Triage BNP test is intended for use with the Beckman Coulter Access Family of Immunoassay Systems for the In Vitro quantitative measurement of B-type natriureti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1861-2014·2014-07-02

    NxStage Dialysate Sack Recalled for Excess Aluminum Levels

    NxStage Medical is recalling 91 cases of dialysate sacks because aluminum levels exceeded internal specifications. The product was distributed in the US and internationally.

    Product
    NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-407 Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 105, Glucose (mg/dL) 100 Batch Size (liters) 50
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1856-2014·2014-07-02

    NxStage Dialysate Sacks Recalled for Excess Aluminum Levels

    NxStage Medical is recalling dialysate sacks used with the PureFlow SL system because they contain aluminum levels exceeding internal specifications.

    Product
    NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-303 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 100m Chloride 100m, Glucose (mg/dL) 100 Batch Size (liters) 50 The SAK is one of the disposables used with NxStage PureFlow SL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1897-2014·2014-07-02

    Anspach Custom Pneumatic Motor Recall for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling 45 Anspach Custom XMax Pneumatic Motors because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***Custom XMax Motor, Pneumatic***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1882-2014·2014-07-02

    Anspach Sagittal microSaw Attachment Recalled for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling two custom Sagittal microSaw Attachments because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF 98-0003***Sagittal microSaw Attachment Custom***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Food)·F-2043-2014·2014-07-02

    Princess House Tangerine Appetizer Plate Set Recalled for Cadmium Leaching

    Princess House Inc. is recalling 11,912 sets of Marissa Collection Tangerine Appetizer Plates because they leach cadmium above acceptable levels.

    Product
    Marissa Collection Tangerine Appetizer Plate Set (set of 2). distributed by Princess House Inc., Taunton, MA
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1864-2014·2014-07-02

    Philips Ingenia 3.0T MRI Systems Recalled for Incorrect Hardware

    Philips is recalling 18 Ingenia 3.0T MRI systems because incorrect M10 nuts were used instead of stainless steel nuts.

    Product
    Ingenia 3.0T, magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1902-2014·2014-07-02

    Anspach Custom QD11 Attachment Recalled for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling three Custom QD11 Attachments because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***Custom QD11 Attachment with thinner nose tube***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1892-2014·2014-07-02

    Anspach Custom MDA Tube Recalled for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling Custom MDA Tubes because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF 98-0025***Custom MDA Tube for use with MA-D20 Attachment***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1845-2014·2014-07-02

    Siemens RAD Fluoro Uro System Recalled for Image Malfunction

    Siemens is recalling 76 RAD Fluoro Uro Systems because a software malfunction can cause images to appear very dark, potentially leading to unnecessary repeat examinations.

    Product
    Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G. Product Usage: Image Intensified Fluoroscopic X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1852-2014·2014-07-02

    Spacelabs Qube Compact Monitor Recalled for Network Connection Loss

    Spacelabs Healthcare is recalling Qube Compact Monitors due to a potential loss of network connection when switching to the Qube Docking Station without powering down.

    Product
    Spacelabs Healthcare Qube Compact Monitor, Model 91390. Intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces.
    Category
    Medical Device
    Distribution
    35 states
  • ModerateFDA (Devices)·Z-1899-2014·2014-07-02

    Anspach eMax 2 Plus Hand Control Recalled for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling two eMax 2 Plus Hand Controls because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF 98-0043***Custom Device eMax 2 Plus Hand Control that will work with a Speed Reducer***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1886-2014·2014-07-02

    Anspach Modified QD11 Attachment Recalled for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling six Modified QD11 Attachments because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***Modified QD11 Attachment with Soft Tissue Protector***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1830-2014·2014-07-02

    Beckman Coulter Recalls UniCel DxH Analysis Systems for Optical Defect

    Beckman Coulter is recalling UniCel DxH800 and DxH600 systems because optical degradation may delay reporting of specific blood test results.

    Product
    Coulter DxH Cleaner 5L, Part No. 628022. For use on UniCel DxH Systems for components that come in contact with blood samples.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1905-2014·2014-07-02

    Anspach 13 mm Drill with Depth Stop Recalled for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling 13 mm Drills with Depth Stops because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF SP-3012-00***13 mm Drill with Depth Stop for Short Heavy Duty Attachment***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1877-2014·2014-07-02

    Anspach 8 mm Coarse Headless Screw Recall for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling 8 mm Coarse Headless Screws because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF 98-0022***8 mm Coarse Headless Screw with Driver***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1898-2014·2014-07-02

    Anspach XMax Motor Recalled for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling three XMax Motor units because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF 98-0042***XMax Motor with Custom Hose***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1904-2014·2014-07-02

    Anspach eMax2 Plus Hand Control Recalled for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling eMax2 Plus Hand Controls because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF-98-0062***Custom Device eMax2 Plus Hand Control***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1876-2014·2014-07-02

    Anspach Modified Arthroscopic Knotless Suture Anchor Deployment Tool Recalled

    The Anspach Effort, Inc. is recalling Modified Arthroscopic Knotless Suture Anchor Deployment Tools because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF 98-0020***Modified Arthroscopic Knotless Suture Anchor Deployment Tool with Suture Puller***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1890-2014·2014-07-02

    Anspach Custom 5 cm Extension Bearing Sleeve Recalled for Quality Issues

    The Anspach Effort, Inc. is recalling two custom extension bearing sleeves because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF 98-0023***Custom 5 cm Extension Bearing Sleeve***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1888-2014·2014-07-02

    Anspach Modified MDA Tube Recalled for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling Modified MDA Tubes with MA-D20 Attachments because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF 98-0019***Modified MDA Tube with MA-D20 Attachment***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1894-2014·2014-07-02

    Anspach Custom Pneumatic Motor Devices Recalled for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling 16 custom pneumatic motor devices because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF 98-0034***Custom XMax Motor, Pneumatic with Hand Control and Custom Autolube III IRR Foot Pedal***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1896-2014·2014-07-02

    Anspach Custom Device SC2102 Recalled for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling Anspach Custom Device SC2102 units because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF 98-0037***Custom Device SC2102 with fast stop firmware***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1843-2014·2014-07-02

    BioFire FilmArray Blood Culture Identification Panel Recalled for False Positives

    BioFire is recalling the FilmArray Blood Culture Identification Panel due to an increased risk of false positive results when used with specific blood culture bottles.

    Product
    FirmArray Blood Culture Identification (BCID) Panel, Model 2.0 The FilmArray Blood Culture Identification (BCID) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test designed to test positive blood cultures to quickly identify the organism that is gro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1912-2014·2014-07-02

    Anspach recalls 3mm Coarse Diamond Ball attachments for quality system issues

    The Anspach Effort, Inc. is recalling 40 units of 3mm Coarse Diamond Ball attachments because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF SP-4603-00***3mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1745-2014·2014-07-02

    Philips Brilliance CT Big Bore Recalled for Radio Frequency Emission Tolerance Issues

    Philips is recalling 454 Brilliance CT Big Bore systems because internal testing found radio frequency emissions exceeded IEC 60601-1-2 standards.

    Product
    Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System & Brilliance CT Big Bore Radiology Whole Body Computed Tomography X-Ray System. Product Usage: The Brilliance CT Big Bore is a Whole Body Computed Tomography X-Ray System which produces cross-secti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1411-2014·2014-07-02

    Bausch & Lomb Recalls Sodium Chloride Ophthalmic Ointment Due to Crystallization

    Bausch & Lomb is recalling 35,253 tubes of Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%, due to crystal precipitate formation causing a gritty sensation in the eye.

    Product
    Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%, 1/8 oz. (3.5 g) tube per carton, Distributed by Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-5315-38, UPC 3 09045 31538 5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1926-2014·2014-07-02

    Siemens Dimension LOCI Troponin I Calibrator Recalled for Result Shifts

    Siemens is recalling Dimension LOCI Troponin I Calibrators because they may cause a 24% upward shift in test results.

    Product
    Siemens Dimension LOCI TNI Troponin I Calibrator RC 621. The LOCI TNI Troponin I Calibrator is an in vitro diagnostic product for the calibration of the cardiac troponin I (TNI) method for the Dimension clinical EXL integrated chemistry system with LOCI module.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1878-2014·2014-07-02

    Anspach 8 mm Coarse Threaded Headless Bone Screw Recalled for Quality Issues

    The Anspach Effort, Inc. is recalling 10 units of 8 mm Coarse Threaded Headless Bone Screws because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF 98-0029***8 mm Coarse Threaded Headless Bone Screw***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1875-2014·2014-07-02

    Anspach Knotless Suture Anchor Deployment Tool Recalled for Quality Issues

    The Anspach Effort, Inc. is recalling Knotless Suture Anchor Deployment Tools because the units and records were not consistent with Quality System requirements.

    Product
    ANSPACH***Knotless Suture Anchor Deployment Tool, Custom***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1865-2014·2014-07-02

    Philips Recalls Ingenia MRI Systems Due to Incorrect Nut Material

    Philips is recalling 24 Ingenia 1.5T MRI systems because some units shipped between December 2013 and March 2014 were supplied with incorrect M10 nuts instead of A4 stainless steel nuts.

    Product
    Ingenia 1.5T, magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1903-2014·2014-07-02

    Anspach Custom Device Autolube III Recalled for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling Anspach Custom Device Autolube III units because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF-98-0056***Custom Device Autolube III modified with a swivel***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1916-2014·2014-07-02

    Anspach Arthroscopic Suture Anchor Threaders Recalled for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling Anspach Custom Devices, specifically arthroscopic suture anchor threaders, because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF SP-5000-00***Threaders, Arthroscopic Suture Anchor***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • LowFDA (Devices)·Z-1930-2014·2014-07-02

    Microgenics Recalls MAS Omni Immune PRO Controls Due to Labeling Error

    Microgenics Corporation is recalling MAS Omni Immune PRO Controls because the package insert failed to reflect the removal of the constituent Inhibin A.

    Product
    MAS Omni Immune PRO Controls
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1929-2014·2014-07-02

    Microgenics Recalls MAS Omni Immune Controls Due to Labeling Error

    Microgenics Corporation is recalling MAS Omni Immune Controls because the package insert failed to reflect the removal of the constituent Inhibin A.

    Product
    MAS Omni Immune Controls
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1819-2014·2014-07-02

    Nitinol HydroFinity Hydrophilic Guidewire Recalled for Polymer Jacket Damage

    Nitinol Devices and Components, Inc. is recalling HydroFinity Hydrophilic guidewires because reports indicate the outer polymer jacket may be damaged during use.

    Product
    HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Angled Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA Manufactured in Costa Rica. The HydroFinity Hydrophi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V396000·2014-07-01

    Volkswagen Recalls 2009 Routans for Ignition Switch Safety Defect

    Volkswagen is recalling 2009 Routans because the ignition switch may move out of the run position, turning off the engine and disabling safety systems.

    Product
    VOLKSWAGEN — VOLKSWAGEN ROUTAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V395000·2014-07-01

    Land Rover Recalls LR2 and Range Rover Evoque for Air Bag Defect

    Land Rover is recalling 2010-2015 LR2 and 2012-2013 Range Rover Evoque vehicles because a component failure may disable the front passenger air bag, increasing injury risk in a crash.

    Product
    LAND ROVER — LAND ROVER LR2, RANGE ROVER EVOQUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V386000·2014-07-01

    Mercedes-Benz Recalls 2014 SL and SLK Models for Air Bag Defect

    Mercedes-Benz is recalling 2014 SL and SLK models because the front passenger air bag may not deploy properly, increasing injury risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ SL550, SLK55, SL63, SLK250
    Category
    Vehicle
    Distribution
    Distributed nationwide

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