The Recall Desk

Archive

March 2016 recalls

772 recalls were announced in March 2016.

What the numbers show

Critical
29
Severe
169
High
353
Moderate
197
Low
24

Of the 772 recalls this month scored against our rubric, 4% are Critical, 22% are Severe.

101–200 of 772

  • ModerateFDA (Food)·F-0773-2016·2016-03-30

    ShopRite Unsalted Dry Roasted Cashews Recalled for Mislabeling

    Wakefern Foods Corp. is recalling ShopRite Unsalted Dry Roasted Cashews because the product may be mislabeled.

    Product
    ShopRite Dry Roasted Unsalted Cashews 7 oz. (198 g) Distributed by Wakefern Food Corp., Elizabeth, NJ 07207 UPC 4119001620
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1244-2016·2016-03-30

    MHI-TM2000 Linear Accelerator Software Recall for Treatment Status Error

    Mitsubishi Heavy Industries is recalling MHI-TM2000 Linear Accelerator Systems due to a software anomaly that may incorrectly change a patient's treatment status to 'Untreated'.

    Product
    MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1235-2016·2016-03-30

    AcuFocus Recalls KAMRA Corneal Inlays Due to Shelf Life Labeling Concerns

    AcuFocus is recalling 182 KAMRA ACI 7000 Corneal Inlays because of concerns regarding the labeled shelf life. The devices were distributed in Canada, Germany, Saudi Arabia, Turkey, and the United Kingdom.

    Product
    KAMRA Inlay, ACI 7000 Corneal Inlay, Part No. 76195-01 and 76195-10 (OUS) Labeling: The KAMRA inlay is indicated for the improvement of near visual acuity in one eye (usually the non-dominant eye) of a presbyopic patient.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1232-2016·2016-03-30

    Siemens syngo X Workplace Medical Workstation Recalled for Segmentation Error

    Siemens Medical Solutions USA is recalling six syngo X Workplace medical workstations because imported segmentation results appear mirrored, rendering them unusable for ablation procedures.

    Product
    syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing during interventional procedures. .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1234-2016·2016-03-30

    Medtronic Recalls BioTex Reusable Adapter Kits Lacking FDA Clearance

    Medtronic Navigation is recalling four BioTex Reusable Adapter Kits because they were distributed without FDA 510(k) clearance.

    Product
    BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for steam sterilization The Adapter Kit is used during surgical procedures as an instrument guide holder that maintains the position of an instrument after they have been aligned by
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1240-2016·2016-03-30

    Siemens Estradiol Test Recalled Due to Potential False Results

    Siemens is recalling ADVIA Centaur Enhance Estradiol tests because the drug fulvestrant may cause falsely elevated results.

    Product
    Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490889, 10491445, 10697757 Product Usage: For in vitro diagnostic use in the quantitative determination of estradiol in human serum and plasma (heparinized and EDTA) using the ADVIA Centaur¿, ADVIA Cent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1237-2016·2016-03-30

    Cook Medical Recalls Nephrostomy Balloon Sets Due to Labeling Mix-up

    Cook Medical is voluntarily recalling specific lots of Ultraxx Nephrostomy Balloon Sets and Ascend AQ Ureteral Dilation Balloon Catheter Sets because of a labeling mix-up.

    Product
    UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon Set consists of a radiopaque balloon catheter, radiopaque sheath, and inflation device. The Ultraxx" Nephrostomy Balloon Set is used to dilate the musculofascia, renal capsule, and parenchyma to establish and mai
    Category
    Medical Device
    Distribution
    6 states
  • SevereNHTSA·16V176000·2016-03-29

    Forest River Georgetown RVs Recalled for Missing Emergency Egress Window

    Forest River is recalling 2015-2017 Georgetown RVs because a vented window was installed instead of a required secondary egress window, posing a risk of entrapment.

    Product
    FOREST RIVER — FOREST RIVER GEORGETOWN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V177000·2016-03-29

    Terex Recalls 2011-2016 Aerial Devices Due to Inadequate Boom Tip Welds

    Terex is recalling 2011-2016 aerial devices because inadequate welds at the boom tip may cause the platform to tilt unexpectedly, increasing the risk of user injury.

    Product
    TEREX — TEREX AERIAL DEVICES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V175000·2016-03-29

    Forest River Recalls 2013-2016 Puma Trailers for Tire Clearance Issue

    Forest River is recalling 2013-2016 Puma recreational trailers because tires may contact the wheel well on bumps, risking tire damage and loss of control.

    Product
    FOREST RIVER — FOREST RIVER PUMA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·16124·2016-03-28

    Fiskars 32-Inch Bypass Lopper Shears Recalled for Laceration Hazard

    CPSC reannounced the recall of Fiskars 32-inch bypass lopper shears after additional injuries were reported. Consumers should stop using the product and contact Fiskars for a free replacement.

    Product
    Fiskars® 32-Inch Bypass Lopper Shears
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V173000·2016-03-25

    BMW Recalls 2016 7 Series Vehicles Due to Air Bag Control Module Defect

    BMW is recalling 6,110 model year 2016 740Li, 750Li, and 750Lxi vehicles because the air bag control module may reset, preventing air bags from deploying in a crash.

    Product
    BMW — BMW 750LXI, 740LI, 750LI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V171000·2016-03-24

    Volkswagen Recalls 2012-2014 Passat TDI Vehicles for Fire Risk

    Volkswagen is recalling 2012-2014 Passat TDI vehicles because water can corrode electrical connectors, causing a short that may lead to a fire.

    Product
    VOLKSWAGEN — VOLKSWAGEN PASSAT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16E023000·2016-03-24

    Honda Recalls PCX Scooter Accessory Trunk Bases for Detachment Risk

    Honda is recalling accessory rear trunk bases for PCX125 and PCX150 scooters because the locking hook may not fully engage, allowing the trunk to detach while riding.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0766-2016·2016-03-23

    Wilderness Family Naturals Tomato Basil Soup Recalled for Milk Contamination

    Wilderness Family Naturals is recalling specific Tomato Basil Soup products due to potential milk contamination. The recall covers over 5,500 units distributed in the US and Canada.

    Product
    Morning Star Disaster Supplies Tomato Basil Soup, Net Wt 3.88 oz (110 g), UPC 853328-006120, Foil Bag Wilderness Family Naturals Quick Meal Tomato Basil Soup, Net Wt 3.88 oz (110 g). UPC 853328-006243, Foil Bag
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0772-2016·2016-03-23

    Wilderness Family Naturals Recalls Butternut Squash Soup for Milk Contamination

    Wilderness Family Naturals is recalling specific lots of Butternut Squash Soup due to potential milk contamination from an ingredient.

    Product
    Morning Star Disaster Supplies Butternut Squash Soup, Net Wt 4.75oz (135 g). UPC 853328-006113, Foil Bag Wilderness Family Naturals Quick Meal Butternut Squash Soup, Net Wt 4.75 oz (135 g). UPC 853328-006182, Foil Bag
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V169000·2016-03-23

    Porsche Recalls Cayenne Vehicles Due to Brake Pedal Pivot Pin Defect

    Porsche is recalling 2011-2016 Cayenne vehicles because a missing circlip may allow the brake pedal to dislodge, potentially preventing the driver from braking.

    Product
    PORSCHE — PORSCHE CAYENNE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0769-2016·2016-03-23

    Wilderness Family Naturals Jamaican Beans and Rice Recalled for Milk Contamination

    Wilderness Family Naturals is recalling specific lots of Jamaican Beans and Rice products due to potential milk contamination.

    Product
    Morning Star Disaster Supplies Jamaican Beans and Rice, Net Wt 8.62 oz (244 g). UPC 853328-006076, Foil Bag Wilderness Family Naturals Quick Meal Jamaican Beans and Rice, Net Wt 8.62 oz (244 g). UPC 898392-007987, Foil Bag
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0767-2016·2016-03-23

    Wilderness Family Naturals Coconut Milk Powder Recalled for Milk Contamination

    Wilderness Family Naturals is recalling Organic Coconut Milk Powder and related products due to potential milk contamination.

    Product
    Morning Star Disaster Supplies Creamy Coconut Rice Soup, Net Wt 7.25 oz (206 g). UPC 853328-006038, Foil Bag Wilderness Family Naturals Quick Meal Creamy Coconut Rice Soup, Net Wt 7.25 oz (206 g). UPC 853328-006038, Foil Bag
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0764-2016·2016-03-23

    Wilderness Family Naturals Organic Coconut Milk Powder Recalled for Milk Contamination

    Wilderness Family Naturals is recalling Organic Coconut Milk Powder and related products due to potential milk contamination.

    Product
    Morning Star Disaster Supplies Quick Meal Mexican Corn Soup Mix Net Wt. 8.1 oz (230g)., Foil Bag. UPC 853328-006090 Wilderness Family Naturals Quick Meal Mexican Corn Soup Mix., Net Wt 8.1 oz (230 g)., Foil Bag. UPC 898392-007949
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0759-2016·2016-03-23

    Wilderness Family Naturals Coconut Chia Pudding Mix Recalled for Milk Contamination

    Wilderness Family Naturals is recalling Organic Coconut Chia Pudding Mix due to potential milk contamination. The product was distributed nationwide in the US and in Canada.

    Product
    Wilderness Family Naturals Coconut Chia Pudding Mix Organic, packaged in the following sizes: 1.1 lb Plastic Bag, UPC 898392-007789, and 13.2 lb. (12 plastic bags in a cardboard box) UPC 01002466
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V168000·2016-03-23

    Chrysler Recalls 2015-2016 Jeep and Dodge Vehicles for Brake Caliper Defect

    Chrysler is recalling 21,183 2015-2016 Jeep Grand Cherokee and Dodge Durango vehicles because the left front brake caliper may crack, increasing stopping distance and crash risk.

    Product
    DODGE — DODGE, JEEP DURANGO, GRAND CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0757-2016·2016-03-23

    Wilderness Family Naturals Coconut Milk Powder Recalled for Milk Contamination

    Wilderness Family Naturals is recalling Organic Coconut Milk Powder and products containing it due to potential milk contamination.

    Product
    Wilderness Family Naturals Coconut Milk, Powdered, Organic packaged in the following sizes: 1) 16 oz foil pouch, UPC 98392-00769; 2) 12 lb. Case of 12 - 1 lbs packages, UPC 01002457 3) 5 lb. bag, UPC 98392-00770 4) 30 lb. Case of 6 - 5 lb. packages, UPC 01002458 5) Case
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0774-2016·2016-03-23

    Teva Recalls Paricalcitol Capsules Due to Impurity Test Failures

    Teva Pharmaceuticals is recalling Paricalcitol Capsules because stability testing revealed out-of-specification impurities. The recall covers 30,891 bottles distributed nationwide and in Puerto Rico.

    Product
    Paricalcitol Capsules, 1 mcg, 30 tablets per Bottle, Rx Only, Manufactured By: Pharmaceutics International, Inc., Hunt Valley, MD 21031, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7656-56.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0768-2016·2016-03-23

    Wilderness Family Naturals Coconut Curry Recalled for Milk Contamination

    Wilderness Family Naturals is recalling specific Coconut Vegetable Curry over Quinoa products due to potential milk contamination.

    Product
    Morning Star Disaster Supplies Coconut Vegetable Curry over Quinoa, Net Wt 4.95 oz (115 g). UPC 853328-006069, Foil Bag Wilderness Family Naturals Quick Meal Coconut Vegetable Curry over Quinoa, Net Wt 4.95 oz (115 g). UPC 853328-006229, Foil Bag
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0765-2016·2016-03-23

    Wilderness Family Naturals Coconut Milk Powder Recalled for Milk Contamination

    Wilderness Family Naturals is recalling Organic Coconut Milk Powder and specific chowder products due to potential milk contamination.

    Product
    Morning Star Disaster Supplies ,Creamy Potato Corn Chowder, Net Wt. 7.88 oz (223 g). UPC 853328-006052, Foil Bag Wilderness Family Naturals Quick Meal Potato Corn Chowder, Net Wt 7.88 oz (223 g). UPC 853328-006199, Foil Bag
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0760-2016·2016-03-23

    Wilderness Family Naturals Coconut Chia Pudding Mix Recalled for Milk Contamination

    Wilderness Family Naturals is recalling Organic Coconut Chia Pudding Mix due to potential milk contamination. The product was distributed nationwide in the US and in Canada.

    Product
    Wilderness Family Naturals Coconut Chia Pudding Mix Sweetened with Coconut Sap Sugar Organic Packaged in the following sizes: 1.1 lb. Plastic Bag, UPC 898392-007796 and 13.2 lb. (12 Plastic Bags in a cardboard box), UPC 01002467
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0762-2016·2016-03-23

    Wilderness Family Naturals Coconut Milk Powder Recalled for Milk Contamination

    Wilderness Family Naturals is recalling Organic Coconut Milk Powder and related products due to potential milk contamination.

    Product
    Wilderness Family Naturals Choco Maca Strawberry Cereal Organic 8 oz.., Foil Bag UPC 898392-007819
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1181-2016·2016-03-23

    Puritan Bennett 980 Ventilator Recalled for Touchscreen and Ventilation Issues

    Medtronic is recalling 1,864 Puritan Bennett 980 ventilators worldwide due to unresponsive touchscreens and potential loss of primary ventilation.

    Product
    Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide continuous ventilation for pediatric and adult patients who require either invasive ventilation or non-invasive ventilation.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Food)·F-0771-2016·2016-03-23

    Wilderness Family Naturals Coconut Milk Powder Recalled for Milk Contamination

    Wilderness Family Naturals is recalling Organic Coconut Milk Powder and related soup products due to potential milk contamination.

    Product
    Morning Star Disaster Supplies Creamy Mushroom Wild Rice Soup, Net Wt 7.3 oz (207 g). UPC 853328-006045, Foil Bag Wilderness Family Naturals Quick Meal Creamy Mushroom Wild Rice Soup Mix, Net Wt 7.3 oz (207 g). UPC 898392-007994, Foil Bag
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0758-2016·2016-03-23

    Wilderness Family Naturals Organic Hot Chocolate Mix Recalled for Milk Contamination

    Wilderness Family Naturals is recalling Organic Hot Chocolate Mix and other products containing Organic Coconut Milk Powder due to potential milk contamination.

    Product
    Wilderness Family Naturals Cacao, Organic Hot Chocolate Mix Packaged in the following sizes: 1 lb. Foil Bag, UPC 898392-007765; 12 lb. (12 - 1 lb. Foil Bags in a cardboard box), UPC 01002464; 5 lb. Foil Bag, UPC 898392-007772; and 30 lb. (6-5lb. Foil Bags in a cardboard
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1149-2016·2016-03-23

    Zimmer NexGen Option Stemmed Tibia Recalled for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling NexGen Option Stemmed Tibia components due to insufficient sealer calibration data, raising concerns about the sterility of the devices.

    Product
    Product 51 consists of all product under product code: JWH and same usage: Item no: 598603701 NEXGEN OPTION STEMMED TIB 598603702 NEXGEN OPTION STEMMED TIB 598604701 NEXGEN OPTION STEMMED TIB 598604702 NEXGEN OPTION STEMMED TIB 598605701 NEXGEN OPTION STEMMED TIB 5986057
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1101-2016·2016-03-23

    Zimmer Manufacturing Recalls Unipolar Femoral Heads Due to Sterility Concerns

    Zimmer Manufacturing B.V. is recalling 2,239 unipolar femoral heads used in hip arthroplasty due to insufficient sealer calibration data, raising concerns about the sterility of the devices.

    Product
    Product 3 consists of all products under product code JDI, and same usage: Item no:781803800 12/14 UNIPOLAR FEMORAL HE 781804000 12/14 UNIPOLAR FEMORAL HE 781804100 12/14 UNIPOLAR FEMORAL HE 781804200 12/14 UNIPOLAR FEMORAL HE 781804300 12/14 UNIPOLAR FEMORAL HE 781804400 1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1174-2016·2016-03-23

    Cordis Avanti Catheter Sheath Introducer System Recalled for Incorrect Cannula Size

    Cordis Corporation is recalling 1,985 units of the Avanti Catheter Sheath Introducer System because the cannula is smaller than intended.

    Product
    CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneous entry of an intravascular device. A vessel dilator facilitates the percutaneous entry of the CS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0749-2016·2016-03-23

    Dawn's Potato Salad Recalled for Undeclared Milk, Wheat, and Soy Allergens

    Dawn's Foods is recalling Deluxe and Deviled Egg Potato Salads due to mislabeling and potential undeclared milk, wheat, and soy allergens.

    Product
    Dawn's Deviled Egg Potato Salad, Net Wt. 15 oz. (397g), UPC 32345-10107. Keep Refrigerated.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1164-2016·2016-03-23

    Zimmer Versys Advocate Hip Implants Recalled for Calibration Issues

    Zimmer Manufacturing B.V. is recalling Versys Advocate hip implants due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 66 consists of all product under product code: JDI and same usage: Item no: 785001100 VERSYS ADVOCATE CEMENTED 785001200 VERSYS ADVOCATE CEMENTED 785001220 VERSYS ADVOCATE CEMENTED 785001300 VERSYS ADVOCATE CEMENTED 785001320 VERSYS ADVOCATE CEMENTED 785001400 VER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1148-2016·2016-03-23

    Zimmer NexGen MIS Tibia Plate Recall for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling NexGen MIS Tibia Plates due to insufficient sealer calibration data, raising concerns about the sterility of the devices.

    Product
    Product 50 consists of all product under product code: JWH and same usage: Item no: 595002701 NEXGEN MIS TIBIA PLATE PR 595002702 NEXGEN MIS TIBIA PLATE PR 595003701 NEXGEN MIS TIBIA PLATE PR 595003702 NEXGEN MIS TIBIA PLATE PR 595003712 NEXGEN MIS TIBIA PLATE PR 5950047
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1098-2016·2016-03-23

    Deerfield Imaging Recalls Intraoperative MRI Systems Due to Venting Line Defect

    Deerfield Imaging is recalling specific intraoperative MRI systems because emergency helium venting lines may not have been properly installed.

    Product
    Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic resonance diagnostic device (MRDD).
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1126-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Femoral Hip Implant Components

    Zimmer Manufacturing B.V. is recalling specific sterile femoral hip implant components due to insufficient sealer calibration data.

    Product
    Product 28 consists of all product under product code: JDI and same usage: Item no: 32902605000 FEMORAL HD 28MM MEDIUM 32902604000 FEMORAL HD 28MM SHORT 32902604035 FEMORAL HD 28MM SHT+ 3.5M For use in total or hemi hip arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1100-2016·2016-03-23

    Zimmer Manufacturing Recalls Hip Femoral Heads Due to Calibration Issues

    Zimmer Manufacturing B.V. is recalling 35,032 hip femoral heads due to insufficient sealer calibration data. The affected sterile products were packaged between August 2010 and April 2013.

    Product
    Product 2 consists of all products product code LPH, and same usage: 801802202 12/14 COCR FEMORAL HEAD 2 801802220 12/14 COCR FEMORAL HEAD 2 801802230 12/14 COCR FEMORAL HEAD 2 801802601 12/14 COCR FEMORAL HEAD 2 801802602 12/14 COCR FEMORAL HEAD 2 801802603 12/14 COCR FEMO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1113-2016·2016-03-23

    Zimmer Astel Femoral Head Recall Due to Sealer Calibration Data

    Zimmer Manufacturing B.V. is recalling sterile Astel femoral heads for hip arthroplasty due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 15 consists of all product code JDI , and same usage: Item no: 805002802 ASTEL FEM HEAD +0X28MM DI 805002805 ASTEL FEM HEAD +10.5X28MM 805002803 ASTEL FEM HEAD +3.5X28MM 805002804 ASTEL FEM HEAD +7X28MM DI 805002801 ASTEL FEM HEAD -3.5X28MM Usage: For use in t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1187-2016·2016-03-23

    Medtronic Recalls Covidien Emprint Percutaneous Antenna Due to Generator Shutdown Risk

    Medtronic is voluntarily recalling specific lots of the Covidien Emprint Percutaneous Antenna because the generator may shut down during high-temperature measurements.

    Product
    Short Percutaneous Antenna with Thermosphere" Technology Standard Percutaneous Antenna with Thermosphere" Technology; The product is packaged in a blister with a tyvek lid, contained in a display box. The numbers of units per carton is 1. Long Percutaneous Antenna with Thermosp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1154-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Bone Fixation Screws Due to Sealer Calibration

    Zimmer Manufacturing B.V. is recalling 56 sterile bone fixation screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 56 consists of all product under product code: HWC and same usage: Item no: 47234702032 PERI SCR 3.5MM X 32MM STE 47234702018 PERI SCR. 3.5MM X 18MM ST 47234702020 PERI SCR. 3.5MM X 20MM ST 47234702022 PERI SCR. 3.5MM X 22MM ST 47234702026 PERI SCR. 3.5MM X 26MM ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0756-2016·2016-03-23

    NatureBox Cinnamon Yogurt Mini Grahams Recalled for Allergen Mislabeling

    NatureBox is recalling Cinnamon Yogurt Mini Grahams because some bags were packaged in Probiotic Power Mix bags that fail to declare wheat as an allergen.

    Product
    NatureBox Cinnamon Yogurt Mini Grahams, 6 oz. (170g) customer stand up pouches. UPC 8 58590 00528 4 Ingredients: Graham Crackers (unbleached unenriched wheat flour, whole wheat graham flour, sugar, palm and palm kernel oil, molasses, honey, salt, sodium bicarbonate). Yogurt
    Category
    Food
    Distribution
    0 states
  • HighNHTSA·16V166000·2016-03-23

    Bugatti Recalls Veyron Models Due to Corroding Underbody Aluminum Plates

    Bugatti is recalling 2006-2013 Veyron models because underbody aluminum plates may corrode and detach, posing a road hazard to other vehicles.

    Product
    BUGATTI — BUGATTI VEYRON, VEYRON GRAND SPORT, VEYRON SUPER SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0770-2016·2016-03-23

    Wilderness Family Naturals Coconut Milk Powder Recalled for Milk Contamination

    Wilderness Family Naturals is recalling Organic Coconut Milk Powder and related products due to potential milk contamination.

    Product
    Morning Star Disaster Supplies Broccoli Potato Soup Mix, Net Wt 6.91 oz (196 g). UPC 853328-006014, Foil Bag Wilderness Family Naturals Quick Meal Broccoli Potato Soup Mix, Net Wt 6.91, (196 g). UPC 898392-007963, Foil Bag
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·16V167000·2016-03-23

    Chrysler Recalls 2015-2016 Ram 1500 Trucks for Steering Assist Loss

    Chrysler is recalling 2015-2016 Ram 1500 trucks because contamination on the electric power steering circuit board may cause a short, resulting in the loss of power steering assist.

    Product
    RAM — RAM 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1110-2016·2016-03-23

    Zimmer Manufacturing Recalls 6 Degree COCR Femoral Heads for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling 209 units of 6 Degree COCR Femoral Heads due to insufficient sealer calibration data. The affected sterile products were distributed nationwide in the US.

    Product
    Product 12 consists of all product under product code JDI , and same usage: Item no: 902602935 6 DEGREE COCR FEM HEAD 28 902602835 6 DEGREE COCR FEM HEAD 28 902603235 6 DEGREE COCR FEM HEAD 32 902603335 6 DEGREE COCR FEM HEAD 32 902603600 6 DEGREE COCR FEM HEAD 36 902603
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1129-2016·2016-03-23

    Zimmer Free-Lock Tube and SCP Plate Recall for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling 285 units of Free-Lock Tube & SCP Plate devices due to insufficient sealer calibration data affecting sterility.

    Product
    Product 31 consists of all product under product code: KTT and same usage: Item no: 118113003 FREE-LOCK TUBE & SCP PLAT 118113502 FREE-LOCK TUBE & SCP PLAT 118113503 FREE-LOCK TUBE & SCP PLAT 118114002 FREE-LOCK TUBE & SCP PLAT 118114003 FREE-LOCK TUBE & SCP PLAT 1181145
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1161-2016·2016-03-23

    Zimmer Manufacturing Recalls Trilogy Acet Shells Due to Calibration Issues

    Zimmer Manufacturing B.V. is recalling 2,063 units of Trilogy Acet Shells used in total hip arthroplasty due to insufficient sealer calibration data.

    Product
    Product 63 consists of all product under product code: LPH and same usage: Item no: 620004020 TRILOGY ACET SHELL 40MM O 620004220 TRILOGY ACET SHELL 42MM O 620004420 TRILOGY ACET SHELL 44MM O 620004620 TRILOGY ACET SHELL 46MM O 620004621 TRILOGY ACET SHELL 46MM O 62000482
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1185-2016·2016-03-23

    Stryker Recalls 36 Non-Powered Stretchers Due to Hydraulic Jack Assembly Defect

    Stryker is recalling 36 non-powered stretchers because hydraulic jack assemblies were manufactured with incorrect oil, increasing the risk of leaks or jack drift.

    Product
    Transport Stretcher, and Head and Neck Surgery Stretcher Non-powered stretcher
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1152-2016·2016-03-23

    Zimmer NexGen Taper Plug Recalled for Insufficient Sealer Calibration Data

    Zimmer Manufacturing B.V. is recalling 1,767 NexGen Taper Plugs used in total knee arthroplasty due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 54 consists of all product under product code: JWH and same usage: Item no: 596009900 NEXGEN TAPER PLUG for use in total knee arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1133-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Knee Fluted Rods Due to Sealer Calibration

    Zimmer Manufacturing B.V. is recalling 49 units of sterile I/B II Knee Fluted Rods due to insufficient sealer calibration data.

    Product
    Product 35 consists of all product under product code: JWH and same usage: Item no: 522007300 I/B II KNEE FLUTED ROD, 1 for use in total knee arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1162-2016·2016-03-23

    Zimmer Manufacturing Recalls Unipolar Endo Femoral Heads Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling specific unipolar endo femoral heads used in hip arthroplasty due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 64 consists of all product under product code: JDI and same usage: Item no: 902605101 UNIPOLAR ENDO FEM HEAD 51MM For use in hemi hip arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1141-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Intramedullary Nails Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling 1,102 sterile intramedullary nails distributed nationwide. The recall is due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 43 consists of all product under product code: HSB and same usage: Item no: 224001016 M/DN R-F IM NAIL 10MM DIA 224001018 M/DN R-F IM NAIL 10MM DIA 224001020 M/DN R-F IM NAIL 10MM DIA 224001022 M/DN R-F IM NAIL 10MM DIA 224001024 M/DN R-F IM NAIL 10MM DIA 2240010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1163-2016·2016-03-23

    Zimmer Versa-FX II Keyless Bone Fixation Devices Recalled for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling 5,538 units of Versa-FX II Keyless bone fixation devices due to insufficient sealer calibration data affecting sterility.

    Product
    Product 65 consists of all product under product code: KTT and same usage: Item no: 119413594 VERSA-FX II KEYLESS SHORT 119413595 VERSA-FX II KEYLESS SHORT 119413596 VERSA-FX II KEYLESS SHORT 119413004 VERSA-FX II KEYLESS TUBE 119413005 VERSA-FX II KEYLESS TUBE 119413006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1128-2016·2016-03-23

    Zimmer Manufacturing Recalls Free-Lock Lag Screws Due to Sterility Concerns

    Zimmer Manufacturing B.V. is recalling 3,500 units of Free-Lock Lag Screws and related bone fixation products due to insufficient sealer calibration data affecting sterility.

    Product
    Product 30 consists of all product under product code: KTT and same usage: Item no: 118100527 FREE-LOCK LAG SCREW, 12.7 118100535 FREE-LOCK LAG SCREW, 12.7 118100540 FREE-LOCK LAG SCREW, 12.7 118100542 FREE-LOCK LAG SCREW, 12.7 118101022 FREE-LOCK LAG SCREW, 12.7 1181010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1169-2016·2016-03-23

    Zimmer Versis Press Fit Hip Components Recalled for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling 2,388 Versis Press Fit hip arthroplasty components due to insufficient sealer calibration data, raising concerns about the sterility of the devices.

    Product
    Product 71 consists of all product under product code: JDI and same usage: Item no: 783401000 VERSYS PRESS FIT LD/FX ST 783401100 VERSYS PRESS FIT LD/FX SZ 783401200 VERSYS PRESS FIT LD/FX SZ 783401300 VERSYS PRESS FIT LD/FX SZ 783401400 VERSYS PRESS FIT LD/FX SZ 78340150
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1182-2016·2016-03-23

    McKesson Medical Imaging Software Recalled for Potential Image Display Errors

    McKesson is recalling Horizon Medical Imaging and Radiology software due to a design deficiency that may cause incorrect patient images to be displayed.

    Product
    McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1179-2016·2016-03-23

    CareFusion Recalls Alaris VersaSafe Infusion Sets Due to Leakage

    CareFusion is recalling 5,760 Alaris VersaSafe Infusion Sets distributed in Michigan because the split septum port may separate or leak.

    Product
    Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1150-2016·2016-03-23

    Zimmer NexGen Osteotomy Cortical Bone Screws Recalled for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling NexGen Osteotomy Cortical Bone Screws due to insufficient sealer calibration data, raising concerns about the sterility of the devices.

    Product
    Product 52 consists of product code: HWC and same usage: Item no: 525004530 NEXGEN OSTEOTOMY CORT BON 525004540 NEXGEN OSTEOTOMY CORT BON 525006545 NEXGEN OSTEOTOMY CORT BON 525006560 NEXGEN OSTEOTOMY CORT BON 525006565 NEXGEN OSTEOTOMY CORT BON for use in total knee ar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1176-2016·2016-03-23

    CHG Hospital Beds Recalls Spirit Select Beds Due to Alarm Defect

    CHG Hospital Beds is recalling 1,892 Spirit Select beds because the bed exit alarm may fail to function, potentially delaying assistance after a patient fall.

    Product
    The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0750-2016·2016-03-23

    Dawn's Potato Salad Recalled for Undeclared Allergens

    Dawn's Foods is recalling Deluxe and Deviled Egg Potato Salad due to mislabeling and potential undeclared milk, wheat, and soy.

    Product
    Dawn's Deluxe Potato Salad, Net Wt. 15 oz. (425g), UPC 32345-10015. Keep Refrigerated.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1137-2016·2016-03-23

    Zimmer Ion Implanted Femoral Stems Recalled for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling 17 ion implanted femoral stems used in hip arthroplasty due to insufficient sealer calibration data affecting sterility.

    Product
    Product 39 consists of all product under product code: JDI and same usage: Item no: 32902605800 ION IMPLANTED FEM 22MM LO 32902604900 ION IMPLANTED FEM 26MM ME 32902603900 ION IMPLANTED FEM 26MM SH For use in total or hemi hip arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0751-2016·2016-03-23

    Casper's Sea Salt Caramel Pretzel Ice Cream Recalled for Allergen Mislabeling

    Casper's Ice Cream is recalling Sea Salt Caramel Pretzel Ice Cream because it contains Caramel Cashew ice cream, presenting a potential allergen threat.

    Product
    Sea Salt Caramel Pretzel Ice Cream, Red Button Vintage Creamery, 56 fluid ounce, Paper Tub, 6 tubs per case, Distributed by Associated Foods, Inc. Utah; Manufactured by Caspers Ice Cream, Inc. Utah
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1172-2016·2016-03-23

    Roche Recalls Accu-Chek Inform II Base Units Due to Data Loss Risk

    Roche is recalling Accu-Chek Inform II Base Units because they may lose data or mismatch patient records when connected to specific Data Management Systems.

    Product
    Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Glucose Monitoring System Accu-Chek inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional heal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1094-2016·2016-03-23

    Pro-Dex Recalls Sterile Battery Packs for Surgical Screwdrivers

    Pro-Dex Inc is recalling sterile battery packs for the KLS Martin Max Driver because they may contain particulates within the sterile package.

    Product
    Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1184-2016·2016-03-23

    Stryker Recalls Prime Series Stretchers Due to Hydraulic Jack Oil Error

    Stryker is recalling 36 Prime Series Stretchers because hydraulic jack assemblies were filled with incorrect oil, increasing the risk of leaks or jack drift.

    Product
    Prime Series Stretchers (Fifth Wheel, Big Wheel and Zoom) Powered stretcher
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-1117-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Hip Arthroplasty Stems Due to Calibration Issues

    Zimmer Manufacturing B.V. is recalling sterile cemented femoral stems for hip arthroplasty due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 19 consists of all product code: JDI and same usage: Item no: 765301101 CEM FEM ST 11X120 NOCOAT 765301201 CEM FEM ST 12X125 NOCOAT 765301301 CEM FEM ST 13X130 NOCOAT 765301401 CEM FEM ST 14X135 NOCOAT 765301501 CEM FEM ST 15X140 NOCOAT 765301601 CEM FEM ST 16X145
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0753-2016·2016-03-23

    Faye's Texas Naturals Corn Relish Recalled for pH Testing Violations

    Faye's Texas Naturals is recalling 1,979 jars of Chili Petin Corn Relish because pH levels were not tested as required by acidified food regulations.

    Product
    Faye's Texas Naturals Chili Petin Corn Relish Net Wt. 10 oz./283.59 grams in glass jars; 123 S. Courthouse Square Goliad, Texas 77963 (361)645-3136 FAYESTEXASNATURALS.NET
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-1156-2016·2016-03-23

    Zimmer Manufacturing Recalls 119 Sterile Bone Fixation Appliances

    Zimmer Manufacturing B.V. is recalling 119 sterile bone fixation appliances due to insufficient sealer calibration data. The affected products were packaged between August 2010 and April 2013.

    Product
    Product 58 consists of all product under product code: HRS and same usage: Item no: 234800904 PROXIMAL DORSAL ULNA PLT 234800906 PROXIMAL DORSAL ULNA PLT 234800908 PROXIMAL DORSAL ULNA PLT 234800910 PROXIMAL DORSAL ULNA PLT 234801004 PROXIMAL DORSAL ULNA PLT 234801006 PRO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1140-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Femoral and Humeral Intramedullary Nails

    Zimmer Manufacturing B.V. is recalling 1,622 sterile femoral and humeral intramedullary nails due to insufficient sealer calibration data.

    Product
    Product 42 consists of all product under product code: HSB and same usage: Item no: 225224010 M/DN FEM IM NAIL 10MM DIA 225228010 M/DN FEM IM NAIL 10MM DIA 225230010 M/DN FEM IM NAIL 10MM DIA 225232010 M/DN FEM IM NAIL 10MM DIA 225234010 M/DN FEM IM NAIL 10MM DIA 2252360
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1135-2016·2016-03-23

    Zimmer Manufacturing Recalls Interlocking Intramedullary Screws Due to Calibration Issues

    Zimmer Manufacturing B.V. is recalling 1,777 sterile interlocking intramedullary screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 37 consists of all product under product code: HSB and same usage: Item no: 225302055 INTERLOCKING IM SCREW LG 225303055 INTERLOCKING IM SCREW LG 225304055 INTERLOCKING IM SCREW LG 225304555 INTERLOCKING IM SCREW LG 225305055 INTERLOCKING IM SCREW LG 225305555 IN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1102-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Bone Fixation Screws Due to Sealer Calibration

    Zimmer Manufacturing B.V. is recalling 154 sterile bone fixation screws distributed nationwide due to insufficient sealer calibration data.

    Product
    Product 4 consists of all products under product code HWC, and same usage: Item no: 47482002603 2.0 X 26 CORT SCREW CRUCI 47482002803 2.0 X 28 CORT SCREW CRUCI 47482003203 2.0 X 32 CORT SCREW CRUCI 47482003403 2.0 X 34 CORT SCREW CRUCI 47482003603 2.0 X 36 CORT SCREW CRUC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1171-2016·2016-03-23

    Sekisui Diagnostics Recalls Acetaminophen Assay Kits Due to Crystal Formation

    Sekisui Diagnostics is recalling 14,407 Acetaminophen L3K Assay kits because crystal formation in the reagent can cause samples to under-recover.

    Product
    Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosi
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1124-2016·2016-03-23

    Zimmer Distal Femoral Components Recalled for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling specific distal femoral components used in hip arthroplasty due to insufficient sealer calibration data.

    Product
    Product 26 consists of all product under product code: JWH and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL MEDIAL FEMORAL CON 234703208 DISTAL MEDIAL FEMORAL CON 234800504 DISTAL POSTERIOR/LATERAL 234800506 DISTAL POSTERIOR/LATERAL 234800508
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1121-2016·2016-03-23

    Zimmer Manufacturing Recalls Hip Stems Due to Insufficient Sealer Calibration Data

    Zimmer Manufacturing B.V. is recalling specific hip stem products because of insufficient sealer calibration data for items packaged in Building II between August 2010 and April 2013.

    Product
    Product 23 consists of all product code: JDI and same usage: Item no: 801100220 CPT 2 HIP STEM, X-OFFSET 801100320 CPT 3 HIP STEM, X-OFFSET 801100420 CPT 4 HIP STEM, X-OFFSET 801100005 CPT HIP STEM PETITE 801100700 CPT HIP STEM SZ 2 LONG 801100800 CPT HIP STEM SZ 3 LONG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1166-2016·2016-03-23

    Zimmer Versys Hip Implant Recall Due to Insufficient Sealer Calibration Data

    Zimmer Manufacturing B.V. is recalling 1,220 units of Versus hip implants due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 68 consists of all product under product code: JDI and same usage: Item no: 787101360 VERSYS CEM/REV/CALCAR 13X 787101361 VERSYS CEM/REV/CALCAR 13X 787101362 VERSYS CEM/REV/CALCAR 13X 787101363 VERSYS CEM/REV/CALCAR 13X 787101560 VERSYS CEM/REV/CALCAR 15X 78710156
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1155-2016·2016-03-23

    Zimmer Manufacturing Recalls Pressfit Femoral Stems Due to Sealer Calibration

    Zimmer Manufacturing B.V. is recalling sterile pressfit femoral stems used in hip arthroplasty due to insufficient sealer calibration data.

    Product
    Product 57 consists of all product code: JDI and same usage: Item no: 763401000 PRESSFIT FEM ST FX 10 X 115 763401100 PRESSFIT FEM ST FX 11 X 1 763401200 PRESSFIT FEM ST FX 12 X 1 763401300 PRESSFIT FEM ST FX 13 X 1 763401400 PRESSFIT FEM ST FX 14 X 1 763401500 PRESSFIT F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1107-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Orthopedic Fixation Devices Due to Calibration Issues

    Zimmer Manufacturing B.V. is recalling specific sterile orthopedic fixation devices due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 9 consists of all product under HRS, and same usage: Item no: 47494502601 4.5 BROAD SCP PLT, 26 HOL Product Usage: Temporary internal fixation devices designed to stabilize fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1147-2016·2016-03-23

    Zimmer NexGen All-Poly Patella Components Recalled for Calibration Issues

    Zimmer Manufacturing B.V. is recalling NexGen All-Poly Patella and related knee arthroplasty components due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 49 consists of all product under product code: JWH and same usage: Item no: 597206529 NEXGEN ALL-POLY PATELLA, 597206532 NEXGEN ALL-POLY PATELLA, 597206535 NEXGEN ALL-POLY PATELLA, 597206538 NEXGEN ALL-POLY PATELLA, 597206541 NEXGEN ALL-POLY PATELLA, 598801713 NE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1120-2016·2016-03-23

    Zimmer Manufacturing Recalls Hip Arthroplasty Components Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling specific hip arthroplasty components due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 22 consists of all product under product code: JDI and same usage: Item no: 811400218 CPT 12/14 COCR REVISION S 811400318 CPT 12/14 COCR REVISION S 811400420 CPT 12/14 COCR REVISION S 811400423 CPT 12/14 COCR REVISION S 811400426 CPT 12/14 COCR REVISION S 811400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1186-2016·2016-03-23

    Sorin Recalls Stockert Heater-Cooler 3T Units for Instruction Manual Updates

    Sorin Group USA is recalling 1,125 Stockert Heater-Cooler 3T units to update instruction manuals with water quality enhancements.

    Product
    Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85, H3T/120V/60Hz. Device Listing E572259
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1122-2016·2016-03-23

    Zimmer Manufacturing Recalls Distal Femoral Bone Fixation Appliances

    Zimmer Manufacturing B.V. is recalling 37 sterile distal femoral bone fixation appliances due to insufficient sealer calibration data.

    Product
    Product 24 consists of all product under product code: HRS and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL MEDIAL FEMORAL CON 234703208 DISTAL MEDIAL FEMORAL CON 234800504 DISTAL POSTERIOR/LATERAL 234800506 DISTAL POSTERIOR/LATERAL 234800508
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1096-2016·2016-03-23

    Collagen Matrix Recalls NuOSS Cancellous Dental Product Due to Size Error

    Collagen Matrix Inc is recalling 171 units of NuOSS Cancellous dental product shipped to Massachusetts because some units may have the incorrect size.

    Product
    NuOSS Cancellous Intended for use in dental surgery.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1144-2016·2016-03-23

    Zimmer Manufacturing Recalls Mini Magna-FX Cann Screws Due to Calibration Data Issues

    Zimmer Manufacturing B.V. is recalling 3,190 units of Mini Magna-FX Cann Screws because of insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 46 consists of all product under product code: HWC and same usage: Item no: 114204012 MINI MAGNA-FX CANN SCREW 114204016 MINI MAGNA-FX CANN SCREW 114204020 MINI MAGNA-FX CANN SCREW 114204024 MINI MAGNA-FX CANN SCREW 114204028 MINI MAGNA-FX CANN SCREW 114204032 MI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1114-2016·2016-03-23

    Zimmer Manufacturing Recalls Bipolar Hip Liners Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling 8,773 units of bipolar liners and shells for hip arthroplasty due to insufficient sealer calibration data.

    Product
    Product 16 consists of all product under poduct code: KWY and same usage: Item no: 500103822 BIPOLAR LINER 38MM OD X 2 500103922 BIPOLAR LINER 39MM OD X 2 500104022 BIPOLAR LINER 40/41MM OD 500104026 BIPOLAR LINER 40MM OD X 2 500104222 BIPOLAR LINER 42/43 OD X 500104226
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1106-2016·2016-03-23

    Zimmer Manufacturing Recalls 3.5mm Cortical Screws Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling 99 units of 3.5mm cortical screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 8 consists of all products under product code HWC, and same usage: Item no: 47483501201 3.5MM CORT. SCREW 12MM LN 47483501401 3.5MM CORT. SCREW 14MM LN 47483501601 3.5MM CORT. SCREW 16MM LN 47483501801 3.5MM CORT. SCREW 18MM LN 47483503601 3.5MM CORT. SCREW 36MM LN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1105-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Cortical Screws Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling 109 sterile 3.5mm cortical screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 7 consists of all products under product code HWC, and same usage: Item no: 47234801435 3.5MM CORT SCR X 14MM 47234801635 3.5MM CORT SCR X 16MM 47234806535 3.5MM CORT SCR X 65MM 47234807035 3.5MM CORT SCR X 70MM 47234807535 3.5MM CORT SCR X 75MM 47234808035 3.5MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0747-2016·2016-03-23

    CJ Extra Fancy Long Grain Enriched Rice Recalled Due to Rodent Urine

    CJ Distribution is recalling 80 lb. bags of long grain rice after FDA inspection found rodent urine stains on pallets.

    Product
    CJ Extra Fancy Long Grain Enriched Rice. NET WT. 80 lbs (36.20 kg); nylon bag; Product of USA. Item number RG80
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1099-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Bone Fixation Screws Due to Sealer Calibration

    Zimmer Manufacturing B.V. is recalling sterile 1.5 x 6 Cortical Screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 1 consists of all product under , product code: JWH and same usage: Item no: 47481500601 1.5 X 6 CORT SCREW HEX/SE Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod ma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1132-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Knee Patella Components Due to Sealer Calibration

    Zimmer Manufacturing B.V. is recalling 512 sterile I/B II Knee Domed Patella components for total knee arthroplasty due to insufficient sealer calibration data.

    Product
    Product 34 consists of all product under product code: JWH and same usage: Item no: 522001700 I/B II KNEE DOMED PATELLA 522001800 I/B II KNEE DOMED PATELLA 522001900 I/B II KNEE DOMED PATELLA for use in total knee arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1103-2016·2016-03-23

    Zimmer Manufacturing Recalls 2.7mm Cortical Screws Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling 60 sterile 2.7mm cortical screws due to insufficient sealer calibration data. The products were distributed nationwide in the US.

    Product
    Product 5 consists of all products under product code HWC, and same usage: Item no: 47482701001 2.7MM CORT. SCREW 10MM, S 47482701201 2.7MM CORT. SCREW 12MM, S 47482701401 2.7MM CORT. SCREW 14MM, S 47482701601 2.7MM CORT. SCREW 16MM, S 47482701801 2.7MM CORT. SCREW 18M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1127-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Femoral Heads Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling specific sterile femoral heads used in hip arthroplasty due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 29 consists of all product under product code: LPHand same usage: Item no: 32902603800 FEMORAL HEAD +0.5 X 22 MM 32902604810 FEMORAL HEAD +3.5 X 22 MM 32902604845 FEMORAL HEAD +7.0 X 22 MM For use in total or hemi hip arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide

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