The Recall Desk

Archive

November 2012 recalls

569 recalls were announced in November 2012.

What the numbers show

Critical
111
Severe
99
High
164
Moderate
162
Low
33

Of the 569 recalls this month scored against our rubric, 20% are Critical, 17% are Severe.

1–100 of 569

  • HighNHTSA·12V554000·2012-11-30

    Medtec Recalls 2009-2011 Ambulances Due to Bench Top Screw Failure Risk

    Medtec is recalling 977 model year 2009-2011 ambulances because bench top screws may loosen and pull out, causing the bench top to drop and increasing the risk of personal injury.

    Product
    MEDTEC — MEDTEC AMBULANCE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12V553000·2012-11-30

    Ford Recalls 2013 Fusion Vehicles for Headlamp Coating Defect

    Ford is recalling 2013 Fusion vehicles because improperly cured headlamp coatings may become hazy, reducing visibility and increasing crash risk.

    Product
    FORD — FORD FUSION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V552000·2012-11-29

    Daimler Trucks Recalls 2010-2013 Freightliner Chassis for Cruise Control Defect

    Daimler Trucks North America is recalling 2010-2013 Freightliner XB and XC custom chassis because loose diode jumpers may prevent cruise control from disengaging or brake lights from illuminating.

    Product
    FCCC — FCCC redundant CUSTOM CHASSIS XB, redundant CUSTOM CHASSIS XC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12E054000·2012-11-29

    Cummins Recalls Diesel Engines in School Buses Due to Fan Pulley Defect

    Cummins is recalling specific ISB6.7 diesel engines installed in Thomas Built school buses because a fan pulley can fail, causing the engine to overheat and potentially disabling the vehicle.

    Product
    ENGINE AND ENGINE COOLING:ENGINE:DIESEL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0707-2013·2012-11-28

    Torn and Glasser Recalls Salted Peanuts and Peanut Butter for Salmonella Risk

    Torn and Glasser is voluntarily recalling salted in-shell peanuts and one lot of organic peanut butter due to potential Salmonella contamination from Sunland, Inc. ingredients.

    Product
    Salted in-shell Peanuts under the following. Salted in Shell PeanutsGless Ranch Label, Item Number 450-175, Pack Size 24/12 oz bags, UPC Code 72488980310. Salted in Shell PeanutsSun Harvest Label, Item Number 450-248, Pack Size 24/16 oz bags, UPC Code 646670306785. Salte
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Food)·F-0715-2013·2012-11-28

    Sartori Smoked Gouda Recalled for Possible Listeria Contamination

    Sartori Inspirations is recalling Smoked Gouda cheese due to possible Listeria monocytogenes contamination from onion mixes used in manufacturing.

    Product
    Smoked Gouda packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0717-2013·2012-11-28

    Sartori Jalapeno Pimento Cheese Recalled for Listeria Risk

    Sartori Inspirations is recalling Jalapeno Pimento Cheese due to possible Listeria monocytogenes contamination from recalled onion mixes.

    Product
    Jalapeno Pimento Cheese packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0716-2013·2012-11-28

    Sartori Pimento Cheese Recalled for Possible Listeria Contamination

    Sartori Inspirations is recalling Pimento Cheese due to possible Listeria monocytogenes contamination from onion mixes used in manufacturing.

    Product
    Pimento Cheese packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0712-2013·2012-11-28

    Sartori Kalamata Tapenade Recalled for Possible Listeria Contamination

    Sartori Inspirations is recalling Kalamata Tapenade due to possible Listeria monocytogenes contamination from recalled onion mixes.

    Product
    Kalamata Tapenade packaged in 7 oz clear plastic and 5 lb white plastic capacity containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0714-2013·2012-11-28

    Sartori Tex Mex Smoked Gouda Recalled for Listeria Risk

    Sartori Inspirations is recalling Tex Mex Smoked Gouda because it may have been made with onion mixes contaminated with Listeria monocytogenes.

    Product
    Tex Mex Smoked Gouda packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0713-2013·2012-11-28

    Sartori Mediterranean Tapenade Recalled for Possible Listeria Contamination

    Sartori Inspirations is recalling Mediterranean Tapenade due to possible Listeria monocytogenes contamination from onion mixes. The product was distributed to Whole Foods stores nationwide.

    Product
    Mediterranean Tapenade packaged in 7 oz clear plastic and 5 lb capacity white plastic tubs, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0708-2013·2012-11-28

    Torn & Glasser Recalls Organic Peanut Butter and Salted In-Shell Peanuts

    Torn & Glasser Inc. is voluntarily recalling specific lots of Organic Peanut Butter and Salted in-shell peanuts due to potential Salmonella contamination from Sunland, Inc. ingredients.

    Product
    Organic Peanut Butter, Item Number 342-007, Pack size 12/14oz tubs. No UPC code. Product labeling:" ".
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Devices)·Z-0373-2013·2012-11-28

    NuVasive Recalls 6.5mm Noncannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 6.5mm x 40mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    6.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0696-2013·2012-11-28

    Rudi's Organic Bakery Recalls Multigrain Oat Bread Due to Metal Objects

    Charter Baking Company is voluntarily recalling Rudi's Organic Bakery Multigrain Oat Bread due to the possible presence of small metal objects.

    Product
    Rudi's Organic Bakery, Multigrain Oat Bread, 22 oz, UPC 031493-82888-8, packed in flexible plastic bags. Labeling is tan, yellow, white, maroon, and orange with maroon, green, black, white, and orange print writing.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0349-2013·2012-11-28

    NuVasive Recalls 5.5mm Cannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 5.5mm x 30mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    5.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0368-2013·2012-11-28

    NuVasive Recalls 4.5mm Noncannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 4.5mm x 35mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    4.5mm x 35mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0352-2013·2012-11-28

    NuVasive Recalls 5.5mm Cannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 5.5mm x 45mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    5.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0371-2013·2012-11-28

    NuVasive Recalls 5.5mm Noncannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 5.5mm x 45mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    5.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0364-2013·2012-11-28

    NuVasive Recalls 7.5mm Cannulated Screw Shank Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 7.5mm x 45mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    7.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0365-2013·2012-11-28

    NuVasive Recalls 7.5mm Cannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 7.5mm x 50mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    7.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0355-2013·2012-11-28

    NuVasive Recalls 6.5mm Cannulated Screw Shank Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 6.5mm x 30mm Cannulated Screw Shanks because the tulip portion may disengage from the shank after implantation.

    Product
    6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0362-2013·2012-11-28

    NuVasive Recalls 7.5mm Cannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 7.5mm x 35mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    7.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0376-2013·2012-11-28

    NuVasive Recalls 7.5mm Noncannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 7.5mm x 40mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    7.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0367-2013·2012-11-28

    NuVasive Recalls 240 Screw Tulip Medical Devices for Disengagement Risk

    NuVasive Inc is recalling 240 units of Screw Tulip, 5.5mm Rod devices because the tulip portion can disengage from the shank after implantation.

    Product
    Screw Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0354-2013·2012-11-28

    NuVasive Recalls 5.5mm Cannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 5.5mm x 55mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    5.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0409-2013·2012-11-28

    KCI RotoRest Delta Therapy System Head Pack Recalled for Skin Injury

    KCI USA is voluntarily recalling 282 RotoRest Delta Therapy System head packs due to reports of skin breakdown and pressure ulcers.

    Product
    RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumbar fracture, Cervical traction, Skeletal traction
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0369-2013·2012-11-28

    NuVasive Recalls 4.5mm Noncannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 4.5mm x 40mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    4.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0351-2013·2012-11-28

    NuVasive Recalls 5.5mm Cannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 5.5mm x 40mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    5.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0360-2013·2012-11-28

    NuVasive Recalls 6.5mm Cannulated Screw Shank Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 6.5mm x 55mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    6.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0359-2013·2012-11-28

    NuVasive 6.5mm Cannulated Screw Shank Recall for Disengagement Risk

    NuVasive Inc is recalling 240 units of 6.5mm x 50mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    6.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-057-2013·2012-11-28

    Qualitest Recalls Hydrocodone and Acetaminophen Tablets Due to Oversized Pills

    Vintage Pharmaceuticals is recalling 14,445 bottles of hydrocodone and acetaminophen tablets because confirmed complaints found oversized pills with superpotent drug levels.

    Product
    HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0361-2013·2012-11-28

    NuVasive Recalls 7.5mm Cannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 7.5mm x 30mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    7.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0375-2013·2012-11-28

    NuVasive Recalls 6.5mm Noncannulated Screw Shank Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 6.5mm x 50mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    6.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0358-2013·2012-11-28

    NuVasive Recalls 6.5mm Cannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 6.5mm x 45mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    6.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0348-2013·2012-11-28

    NuVasive Recalls 240 Screw Tulip Implants Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 6.25mm Screw Tulip implants because the tulip portion can disengage from the shank after implantation.

    Product
    Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-058-2013·2012-11-28

    Watson Recalls Hydrocodone and Acetaminophen Tablets Due to Superpotent Risk

    Watson Laboratories is recalling specific lots of Hydrocodone Bitartrate and Acetaminophen tablets because they may be oversized and superpotent.

    Product
    Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 00591-0540-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0357-2013·2012-11-28

    NuVasive Recalls 6.5mm Cannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 6.5mm x 40mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    6.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0719-2013·2012-11-28

    Sartori Spinach Feta Dip Recalled for Listeria Risk

    Sartori Inspirations, LLC is recalling Spinach Feta Dip due to possible contamination with Listeria monocytogenes from recalled onion mixes.

    Product
    Spinach Feta Dip packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0353-2013·2012-11-28

    NuVasive Recalls 5.5mm Cannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 5.5mm x 50mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    5.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0378-2013·2012-11-28

    NuVasive Recalls 7.5mm Noncannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 7.5mm x 50mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    7.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0363-2013·2012-11-28

    NuVasive Recalls 7.5mm Cannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 7.5mm x 40mm Cannulated Screw Shanks because the tulip portion may disengage from the shank after implantation.

    Product
    7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0297-2013·2012-11-28

    Biomet 3i Recalls OSSEOTITE Dental Implants Due to Shallow Hex Depth

    Biomet 3i is recalling 191 OSSEOTITE dental implants because a manufacturing defect makes the internal hex too shallow, which may prevent the driver or abutment from fully engaging.

    Product
    Product is Full OSSEOTITE 2 Tapered Certain Implant, Model Number XIFNT413, and size 4 x 13 mm. The product is sterile. Product provides a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utiliz
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-060-2013·2012-11-28

    Ranbaxy Recalls Atorvastatin Calcium Tablets Due to Foreign Tablet Presence

    Ranbaxy Inc. is recalling 32,208 bottles of Atorvastatin Calcium 10 mg tablets because a 20 mg tablet was found inside a sealed 10 mg bottle.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0382-2013·2012-11-28

    Stryker Spine Recalls Specialty Audible Torque Wrenches Due to Fracturing Tips

    Stryker Spine is recalling 28 units of Specialty Audible Torque Wrenches because the hex tips have fractured during use.

    Product
    SPECIALTY AUDIBLE TORQUE WRENCH, XIA IS2217XLP MFG BY: STRYKER SPINE 2 PEARL COURT ALLENDALE NJ 07401-1677 The Xia 3/Mantis Redux/Specialty Audible Torque Wrenches are used to final tighten the blocker of the Xia 3/ Mantis Redux Polyaxial Screws, Hooks, Monoaxial Scr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0419-2013·2012-11-28

    King Systems Recalls Child Silicone Laryngeal Airway Devices Due to Sterilization Indicator Defect

    King Systems Corp. is recalling 2,630 child silicone laryngeal airway devices because sterilization indicators failed to change color as expected, raising concerns about proper EtO sterilization.

    Product
    KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 3 / Child Silicone King LAD¿ Patient Size: 30-50kg Product Usage: Laryngeal airway
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0385-2013·2012-11-28

    Mako Surgical Recalls RIO System Software Due to Tactile Feedback Loss

    Mako Surgical Corporation is recalling 137 RIO System devices to replace software version 2.4 with 2.5, addressing a functional issue involving the loss of tactile feedback.

    Product
    The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RIO is indicated for use in
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-0401-2013·2012-11-28

    Kerr Recalls BioPlant Dental Bone Grafting Material Due to Ossification Delay

    Kerr Corporation is recalling BioPlant dental bone grafting material because disturbing the product may halt or delay the ossification process.

    Product
    BioPlant, a dental bone grafting material. BioPlant has been assigned the product code LYC (Bone Grafting Material, Synthetic) by the FDA and is classified as a Class II Medical Device. BioPlant is a Class II Medical Device. The Device Listing Number is 0007254. BioPlant i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0428-2013·2012-11-28

    IMRIS OR Tables Recalled Due to Magnet Attraction Risk

    IMRIS is recalling ORT100 and ORT200 tables used in MRI systems because the foot end may be attracted to the magnet, posing a risk of injury to patients and operators.

    Product
    IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro II-SE and Neuro III-SV Magnetic Resonance Imaging Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0380-2013·2012-11-28

    Stryker XIA 3 Torque Wrench Recalled Due to Hex Tip Fracture

    Stryker Spine is recalling 54 XIA 3 Torque Wrenches because the hex tip may fracture during use, posing a risk of injury to patients or providers.

    Product
    Stryker XIA 3 TORQUE WRENCH REF 48237028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE +33 (0)5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine, 2 Pearl Ct. Allendale NJ 07401-1677 USA +1-201-780-8000 The Xia 3/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0413-2013·2012-11-28

    Captiva Spine Recalls CapLOX II Final Torque Driver Due to Premature Breakage

    Captiva Spine is recalling 10 units of the CapLOX II Final Torque Driver because the device may break prematurely during use.

    Product
    CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. The CapLOX II Spinal System is a posterior, non-cervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0721-2013·2012-11-28

    Sartori Salsa Cream Cheese Recalled for Listeria Risk

    Sartori Inspirations is recalling Salsa Cream Cheese due to possible Listeria monocytogenes contamination from recalled onion mixes.

    Product
    Salsa Cream Cheese packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0709-2013·2012-11-28

    Titan Gelatin Dessert Recalled for Undeclared Yellow #5 Allergen

    Postres de Aqui, Inc. is recalling Titan Gelatin Dessert in Orange and Strawberry flavors due to undeclared Yellow #5.

    Product
    "Titan Gelatinas***Postres de gelatina (Gelatin Dessert)***Sabor a China (Orange flavored)***Sabor a Fresa (Strawberry flavored)"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0423-2013·2012-11-28

    King Systems Recalls Laryngeal Airway Devices Due to Sterilization Indicator Failure

    King Systems Corp. is recalling 2,630 laryngeal airway devices because sterilization indicators failed to change color, suggesting the devices may not be sterile.

    Product
    KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 4 / Adult ClearSeal King LAD¿ Patient Size: 50-70kg Product Usage: Laryngeal airway
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0720-2013·2012-11-28

    Sartori Salsa Recalled for Possible Listeria Contamination

    Sartori Inspirations is recalling Famous Thick Salsa due to possible Listeria monocytogenes contamination from recalled onion mixes.

    Product
    Famous Thick Salsa packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0291-2013·2012-11-28

    Mindray A5 Anesthesia Delivery System Recalled for Potential System Leak

    Mindray is recalling A5 Anesthesia Delivery Systems due to a potential system leak caused by a carbon dioxide absorber canister gasket issue.

    Product
    Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient's ventilati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0430-2013·2012-11-28

    Biomerieux Recalls 0.9% Sodium Chloride Injections for VITEK 2 System Use

    Biomerieux Inc is recalling 0.9% Sodium Chloride Injections that were distributed as 0.45% Sodium Chloride Saline bags for use with the VITEK 2 system.

    Product
    0.9% Sodium Chloride Injections, USP, 1000ml, VWR/Baxter Product Usage: The concentrated sodium chloride is used to prepare inoculum that is analyzed by the VITEK 2 instrument. The VITEK 2 user manual instructs all users to prepare inoculum with 0.45%-0.50% sodium chloride in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0372-2013·2012-11-28

    NuVasive Recalls 5.5mm Noncannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 5.5mm x 50mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    5.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0434-2013·2012-11-28

    SenTec V-Sign Membrane Changer Insert Recalled for Manufacturing Defect

    Sentec AG is recalling SenTec V-Sign Membrane Changer Inserts due to a manufacturing defect that prevents electrolyte presence, potentially degrading PCO2 sensor performance.

    Product
    SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces. The SenTec V-Sign Membrane Changer Insert is indicated for use with the V-Sign Membrane Changer only. The V-sign Sensor is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of ca
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0722-2013·2012-11-28

    Gilster-Mary Lee Recalls Better Valu Fruit Whirls for Undeclared Almond Butter

    Gilster-Mary Lee Corp. is recalling Better Valu Fruit Whirls because the product contains undeclared almond butter, a major food allergen.

    Product
    Gilster-Mary Lee Corporation, Better Valu Fruit Whirls, Naturally Flavored packaged in a 28 oz (1 LB 12 OZ) (794g) plastic bag. (manufactured by Gilster Mary Lee, Joplin, MO)
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-0412-2013·2012-11-28

    Spine Frontier Inspan Compressors Recalled for Potential Weld Breakage

    SpineFrontier, Inc. is recalling 17 Inspan compressors because they may break at the weld, causing a loss of compression during use.

    Product
    Spine Frontier Inspan compressors Part Number: 11-60004. Inspan compressors provide pressure to drive spikes of Inspan implants into the spinous process bone, resulting in fixation of the implant.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0695-2013·2012-11-28

    Rudi's Organic Bakery Bread Recalled for Possible Metal Contamination

    Charter Baking Company is voluntarily recalling Rudi's Organic Bakery Colorado Cracked Wheat bread due to the possible presence of small metal objects.

    Product
    Rudi's Organic Bakery, Colorado Cracked Wheat, 22 oz, UPC 031493-54373-6, packed in flexible plastic bags. Labeling is tan, yellow, white, maroon, and orange with white, black, green, maroon, and orange print writing.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0406-2013·2012-11-28

    INTRABEAM Balloon Applicator Set Recalled for Manufacturing Defect

    Carl Zeiss Meditec is recalling INTRABEAM Balloon Applicator Sets due to a manufacturing defect that could cause a small tube to become dislodged.

    Product
    INTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0404-2013·2012-11-28

    Carl Zeiss Meditec Recalls INTRABEAM Balloon Applicator Sets

    Carl Zeiss Meditec is recalling 36 INTRABEAM Balloon Applicator Sets due to a manufacturing defect that could cause a small tube to become dislodged.

    Product
    INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0403-2013·2012-11-28

    Spacelabs Qube Compact Patient Monitor Recalled for Input Circuit Failure

    Spacelabs Healthcare is recalling Qube Compact Patient Monitors because the input circuit may fail, causing the device to shut down when batteries deplete or fail to turn on.

    Product
    qube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2 cm x 31.5 cm x 13.2 cm and weighs 4.1 kg (10.3 inches x 12.4 inches x 5.2 inches - 9 lbs). It has a 26.2 cm (12.1 inches) LCD display with 1024 x 768 resolution. The Spacelabs Healthcare Qube Compact Monitor
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0433-2013·2012-11-28

    SenTec V-Sign Membrane Changer Recalled for Manufacturing Defect

    Sentec AG is recalling 195 boxes of SenTec V-Sign Membrane Changers due to a manufacturing defect that prevents electrolyte presence, potentially degrading PCO2 performance.

    Product
    SenTec V-Sign Membrane Changer (VS-MC), 9 pieces. The SenTec V-Sign Membrane Changer is indicated for use with the V-Sign Sensor only. The V-sign Sensor is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension, oxy
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0298-2013·2012-11-28

    Biomet 3i Recalls OSSEOTITE Dental Implants Due to Shallow Hex Depth

    Biomet 3i is recalling 76 OSSEOTITE dental implants because a manufacturing defect makes the internal hex too shallow, potentially preventing proper engagement of drivers or abutments.

    Product
    Product is Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA411. The product is sterile. Product provides a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0350-2013·2012-11-28

    NuVasive Recalls 5.5mm Cannulated Screw Shank Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 5.5mm x 35mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    5.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0422-2013·2012-11-28

    King Systems Recalls Laryngeal Airway Devices Due to Sterilization Indicator Issues

    King Systems Corp. is recalling specific lots of KING LAD Standard ClearSeal laryngeal airway devices because the ethylene oxide sterilization indicators did not change color as expected.

    Product
    KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie10 devices/case Size 3 / Child ClearSeal King LAD¿ Patient Size: 30-50kg Product Usage: Laryngeal airway
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0388-2013·2012-11-28

    Stryker Recalls 6.5mm Cancellous Bone Screws Due to Packaging Mix-Up

    Stryker is recalling 6.5mm Cancellous Bone Screws because packaging may contain the wrong screw length, potentially leading to incorrect surgical fixation.

    Product
    Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6535-1 The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects to use a cluster/multi-hole shell in the acetabulum. The screws are intended to provide initial cup fixation and help prevent spin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0381-2013·2012-11-28

    Stryker Mantis Torque Wrench Recalled for Hex Tip Fracture

    Stryker Spine is recalling 19 Mantis Torque Wrenches because the hex tip may fracture during use. The recall covers units distributed in the US and internationally.

    Product
    Stryker MANTIS TORQUE WRENCH REF 48287028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE +33 (0)5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine, 2 Pearl Ct. Allendale NJ 07401-1677 USA +1-201-780-8000 The Xia 3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0356-2013·2012-11-28

    NuVasive Recalls 6.5mm Cannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 6.5mm x 35mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    6.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0431-2013·2012-11-28

    Stryker Orthobiologics Recalls Vita Plasma Separator Components

    Stryker Orthobiologics is recalling 3,268 units of the Vita Plasma Separator due to a risk of blood displacement during use.

    Product
    Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat. Sterile, single use device designed to prepare plasma from the patient's blood using a tabletop centrifuge.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0377-2013·2012-11-28

    NuVasive Recalls 7.5mm Noncannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 7.5mm x 45mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    7.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0417-2013·2012-11-28

    SpineFrontier Recalls S-Lift Implant Guides Due to Over-insertion Risk

    SpineFrontier, Inc. is recalling 19 units of S-Lift Implant Guides because using them without stops may allow over-insertion, potentially causing patient injury.

    Product
    S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223 Product Usage: Surgical Guides allow a surgeon to place implants into tight spaces, such as a vertebral disc space, without having the implant contact the surrounding bone or tissue. In the case o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·13050·2012-11-28

    G-U Hardware Recalls Window Fittings Due to Injury Hazard

    G-U Hardware is recalling approximately 5,000 window fittings because they can break, causing windows to fall and posing an injury hazard.

    Product
    Window Fittings: Tilt-turn Stay Arms and Side-hung Sash Hinges
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0424-2013·2012-11-28

    King Systems Recalls Laryngeal Airway Devices Due to Sterilization Indicator Issues

    King Systems Corp. is recalling specific lots of Laryngeal Airway Devices because sterilization indicators failed to change color as expected, potentially indicating improper sterilization.

    Product
    KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 5 / Adult ClearSeal King LAD¿ Patient Size: >70kg Product Usage: Laryngeal airway
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0344-2013·2012-11-28

    Extremity Medical Recalls IO Fix IntraOsseous Fixation System Due to Screw Failure

    Extremity Medical LLC is recalling 120 units of the IO Fix IntraOsseous Fixation System because product event reports indicate lag screws may pass through washers during surgery.

    Product
    IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: 888.499.0079. The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0718-2013·2012-11-28

    Sartori Mango Salsa Recalled for Possible Listeria Contamination

    Sartori Inspirations is recalling Mango Salsa due to possible Listeria monocytogenes contamination from recalled onion mixes.

    Product
    Mango Salsa packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0697-2013·2012-11-28

    Rudi's Organic Bakery Recalls Cinnamon Raisin Bread Due to Metal Objects

    Charter Baking Company is voluntarily recalling Rudi's Organic Bakery Cinnamon Raisin bread loaves due to the possible presence of small metal objects.

    Product
    Rudi's Organic Bakery, Cinnamon Raisin, 24 oz, UPC 031493-92183-1, packed in flexible plastic bags. Labeling is tan, yellow, white, blue, maroon, and orange with white, black, green, maroon, and orange print writing.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0407-2013·2012-11-28

    Vital Signs Temperature Probe Recalled for Potential Nosebleed Risk

    Vital Signs Colorado Inc. is recalling 243,685 disposable temperature probes due to a potential risk of nosebleeds during use.

    Product
    Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core temperature
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·13052·2012-11-28

    Sportspower Recalls Children's Waterslides Due to Injury Hazard

    Sportspower is recalling Liquid Motion waterslides sold at Menards because inadequate warning labels pose a risk of serious neck injuries.

    Product
    Liquid Motion waterslides
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13708·2012-11-28

    Kirkland Signature Sauté Pans Recalled Due to Glass Lid Laceration Hazard

    Meyer Marketing is recalling Kirkland Signature six-quart sauté pans sold at Costco because the tempered glass lids can crack or shatter, posing a laceration hazard.

    Product
    Kirkland Signature Six-Quart Sauté Pans with glass lids
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0346-2013·2012-11-28

    Beckman Coulter Recalls UniCel Dxl 600 Access Immunoassay Systems

    Beckman Coulter is recalling 432 UniCel Dxl 600 Access Immunoassay Systems due to confirmed field modifications to probe assemblies.

    Product
    UniCel Dxl 600 Access Immunoassay System, Part Numbers: A30260, A71460, and A71461. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human bod
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0199-2013·2012-11-28

    GE Healthcare Recalls Mobile Radiographic Units Due to Firmware Issue

    GE Healthcare is recalling specific mobile radiographic units due to a firmware issue affecting technique accuracy as mandated by federal regulations.

    Product
    GE Healthcare Optima 200amx Mobile general purpose radiographic imaging of the human head and body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-062-2013·2012-11-28

    Sterling Gelatin Recalls Limed Bone Gelatin Due to C. Difficile Contamination

    American Enterprises LLC is recalling 750 kgs of Limed Bone Gelatin due to possible C. difficile contamination in the raw material.

    Product
    Limed Bone Gelatin, packaged in six 125 kg fiber drums and labeled in part PO NO.: P8095 GELATIN 75 BLOOM ITEM NO. RM 164. MADE IN INDIA
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0347-2013·2012-11-28

    Beckman Coulter Recalls UniCel DxC Immunoassay Systems Due to Field Modifications

    Beckman Coulter is recalling UniCel DxC and Dxl Immunoassay Systems because field modifications were made to the aspirate and dispense probe assemblies.

    Product
    UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems, Part Numbers: A64871, A64903, A64935, A59102. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentration
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0198-2013·2012-11-28

    GE Healthcare Recalls Mobile Radiographic Imaging Systems Due to Firmware Issue

    GE Healthcare is recalling specific mobile radiographic imaging systems due to a firmware issue affecting technique accuracy as mandated by regulations.

    Product
    GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging of the human head and body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0410-2013·2012-11-28

    Zimmer Recalls Multipolar Bipolar Cup Liners Due to Assembly Error

    Zimmer, Inc. is removing 195 Multipolar Bipolar Cup Liners because the split poly ring was incorrectly assembled. The recall covers units distributed in the US and several international countries.

    Product
    Multipolar¿ Bipolar Cup Liner 22 mm LD.; Item 00-5001-040-22 Product Usage: The liner snaps into the Multipolar¿ Bipolar Cup and serves as the articulation surface for the femoral head. The split poly locking ring helps contain the head within the liner and also provides a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0405-2013·2012-11-28

    Carl Zeiss Meditec Recalls INTRABEAM Balloon Applicator Sets Due to Manufacturing Defect

    Carl Zeiss Meditec is recalling 36 INTRABEAM Balloon Applicator Sets because a manufacturing defect could cause a small tube to become dislodged.

    Product
    INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0374-2013·2012-11-28

    NuVasive Recalls 6.5mm Noncannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 6.5mm x 45mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    6.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0370-2013·2012-11-28

    NuVasive Recalls 5.5mm Noncannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 5.5mm x 40mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    5.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0366-2013·2012-11-28

    NuVasive Recalls 7.5mm Cannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 7.5mm x 55mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    7.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0311-2013·2012-11-28

    BioMérieux Software Update Recalled for Patient Information Mislabeling

    BioMérieux is recalling 205 software update kits for clinical instruments due to a defect that may mislabel patient information on culture specimen bottles.

    Product
    bioMerieux Kit, USB HDW, BTA3D60-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411956 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0340-2013·2012-11-28

    Superstat Modified Collagen Hemostatic Sponge Recalled for Missing Sterility Audit Documentation

    Superstat Corp is recalling Modified Collagen Hemostatic Sponges because documentation verifying quarterly dose sterility audits is unavailable.

    Product
    Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 1.5%, Part# 9300-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, eith
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0393-2013·2012-11-28

    Zimmer Recalls VerSys Provisional Femoral Heads for Surgical Technique Updates

    Zimmer, Inc. is recalling VerSys Provisional Femoral Heads to update surgical instructions regarding the visual location of displaced heads.

    Product
    . 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys Femoral Head Provisional 36mm +0 00789503603 VerSys Femoral Head Provisional 36mm +3.5 00789503604 VerSys Femoral Head Provisional 36mm +7 00789503605 VerSys Femoral Head Provisional 36mm +10.5 12/14
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0334-2013·2012-11-28

    Superstat Modified Collagen Hemostatic Sponge Recalled for Sterility Audit Documentation Gaps

    Superstat Corp is recalling Modified Collagen Hemostatic Sponges because documentation is missing to verify that required quarterly dose sterility audits were performed.

    Product
    Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capilla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0324-2013·2012-11-28

    BioMerieux B.40 Software Update Recalled for Patient Mislabeling

    BioMerieux is recalling B.40 software updates because a defect may cause patient information to be mislabeled on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 412002 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0320-2013·2012-11-28

    Biomerieux BacT/ALERT Combo Module Recalled for Software Mislabeling

    Biomerieux is recalling BacT/ALERT Combo Modules due to a software issue that may mislabel patient information on culture specimen bottles.

    Product
    bioMerieux BacT/ALERT Combo Module, catalog number 247014, Industrial instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection,
    Category
    Medical Device
    Distribution
    19 states

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