The Recall Desk

Archive

November 2013 recalls

588 recalls were announced in November 2013.

What the numbers show

Critical
11
Severe
105
High
243
Moderate
221
Low
8

Of the 588 recalls this month scored against our rubric, 2% are Critical, 18% are Severe.

Which agencies issued them

301–400 of 588

  • ModerateFDA (Devices)·Z-0193-2014·2013-11-20

    Terumo Recalls Sarns Soft-Flow Aortic Cannulas Due to Particulate

    Terumo CVS is recalling 90 units of Sarns Soft-Flow Aortic Cannulas because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, angled tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD with 3/8" connector, 14" (36 cm) long. Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0258-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defect

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; UPG MX-RAD SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retriev
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0277-2014·2013-11-20

    Zimmer Recalls Hip Stems Due to Sterile Barrier Integrity Testing

    Zimmer, Inc. is recalling VerSys Hip System femoral stems because historic packaging validations indicated a need for additional testing to ensure sterile barrier integrity.

    Product
    VerSys¿ Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Heritage Hip System Revision Femoral Stems. Indicated for total hip arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0227-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; UNLIMITED READING LIC < 50K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0183-2014·2013-11-20

    Applied Medical Recalls Inzii Tissue Retrieval Bags Due to Packaging Punctures

    Applied Medical is voluntarily recalling Inzii Tissue Retrieval Bags because packaging punctures could compromise the sterile barrier, posing a theoretical risk to patients.

    Product
    Applied Medical's Inzii¿ 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as rec
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0215-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer.

    Product
    Carestream Vue PACS; Virtual PWR Reading Basic SW Workgroup The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, r
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0221-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; Virtual Reading Basic SW StandAlone The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retr
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0187-2014·2013-11-20

    St. Jude Medical Recalls Safire Duo Ablation Catheters Due to Connector Error

    St. Jude Medical is voluntarily recalling 46 Safire Duo Ablation Catheters because they have a cable connector configuration that differs from the intended design.

    Product
    Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx only, Sterile EO. Intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical atrial flutter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0213-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; Virtual PWR Reading Basic SW, Workgroup The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, re
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0250-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<25K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrie
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0232-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defect

    Carestream Health is recalling Vue PACS software because a defect may prevent some CT and MR images from loading in the viewer.

    Product
    Carestream Vue PACS; MX CLINIC SOFTWARE DICOM VIEWING The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0212-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defect

    Carestream Health is recalling Vue PACS software because specific multi-slice CT and MR images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; Virtual Access Plus SW, Workgroup The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrie
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0241-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defect

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; UPG MX-O SVR 15K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0260-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software versions 11.3.2.0, 11.3.2.4, and 11.4 because a defect may prevent some CT and MR images from loading in the viewer.

    Product
    Carestream Vue PACS; UPG MX-RAD SVR 75K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retriev
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Food)·F-0134-2014·2013-11-20

    Specialty Enzymes Recalls Protease Products Due to Chloramphenicol Contamination

    Specialty Enzymes & Biotechnologies is recalling specific protease products because they may contain low levels of chloramphenicol.

    Product
    Protease: APEX 10-7082 CENTURY 7-152 EB 2-14511 EB 5-16901 EB 8-14861 EB 9-14191 EXCLZYME EXCLZYME EN GLOBAL 8-658 HFN 7-7113 META 10-185 MHNHEM 2-158 PEPZYME AG PROTEASE - 1000 PROTEASE 250,000 SEB PRO FP 500 SEB PRO FP 600 SYS 7-7742 UT 11-216 N VEGPANZYME
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0127-2014·2013-11-20

    Dannon Recalls Light & Fit Nonfat Yogurt Due to Potential Yeast Contamination

    The Dannon Company is recalling Light & Fit Nonfat Yogurt because the product may contain yeast. Consumers should check their pantries for the specific affected lot.

    Product
    Dannon LIGHT & FIT¿ Nonfat Yogurt - 4 PACK of 6 oz cups. Vanilla UPC 36632 02721
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·F-0130-2014·2013-11-20

    Dannon Recalls Light & Fit Nonfat Yogurt Due to Potential Yeast Contamination

    The Dannon Company is recalling Light & Fit Nonfat Yogurt because the product may contain yeast. The recall affects 1,942 cases distributed to eight western states.

    Product
    Dannon LIGHT & FIT¿ Nonfat Yogurt - 4 PACK of 6 oz cups. Strawberry/Banana UPC 36632 02181.
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0248-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software versions 11.3.2.0, 11.3.2.4, and 11.4 because specific multi-slice images may fail to load in the viewer.

    Product
    Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<75K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrie
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Food)·F-0129-2014·2013-11-20

    Dannon Recalls Light & Fit Nonfat Yogurt Due to Potential Yeast Contamination

    The Dannon Company is recalling Light & Fit Nonfat Yogurt because the product may contain yeast. The recall affects 4,512 cases distributed across eight western states.

    Product
    Dannon LIGHT & FIT¿ Nonfat Yogurt - 4 PACK of 6 oz cups. Strawberry UPC 36632 02720.
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·F-0135-2014·2013-11-20

    Specialty Enzymes Recalls Cellulase and Protease Products for Chloramphenicol

    Specialty Enzymes & Biotechnologies is recalling cellulase and protease products because they may contain low levels of chloramphenicol.

    Product
    Cellulase & Protease: APEX 10-639 A DIGESEB DIGESEB PLUS DIGESEB SUPER EB 10-14171 EB 10-16192 EB 12-11331 EB 12-9205 EB 14-14201 EB 15-13662 EB 18-13081 EB 7-12831 EB 7-12901 EB 7-14211 EB 8-15731 EL 5-7212 ENZIGEST N FIZYME # 1209 N GLOBAL 8-658 HERB 10-69
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0211-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defect

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; VIRTUAL ACCESS SOFTWARE, WORKGROUP The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retri
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0229-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software versions 11.3.2.0, 11.3.2.4, and 11.4 because a software defect may prevent some CT and MR images from loading.

    Product
    Carestream Vue PACS; UNLIMITED READING LIC ADD 25K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrie
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0228-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defect

    Carestream Health is recalling Vue PACS software because a defect may prevent some CT and MR images from loading into the viewer under specific conditions.

    Product
    Carestream Vue PACS; UNLIMITED READING LIC ADD 10K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrie
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0249-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software versions 11.3.2.0, 11.3.2.4, and 11.4 because specific multi-slice images may fail to load in the viewer.

    Product
    Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<50K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrie
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0210-2014·2013-11-20

    Integra LifeSciences Recalls Mayfield Skull Clamps Due to Locking Issues

    Integra LifeSciences is recalling 37 Mayfield Skull Clamps because the locking knob may not unlock easily or the torque knob may malfunction.

    Product
    Composite Series Skull Clamp, one clamp per tote. The MAYFIELD¿ Skull Clamp (A3059) is a cranial stabilization device, designed to provide rigid skeletal fixation. The Skull Clamp is placed on the patient's skull to hold their head and neck securely in a particular position w
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-0243-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defect

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; UPG MX-O SVR 15K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0255-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defect

    Carestream Health is recalling Vue PACS software versions 11.3.2.0, 11.3.2.4, and 11.4 because specific multi-slice images may fail to load in the viewer.

    Product
    Carestream Vue PACS; MX WEB SW/25 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrie
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0251-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defects

    Carestream Health is recalling Vue PACS software versions 11.3.2.0, 11.3.2.4, and 11.4 because specific multi-slice images may fail to load in the viewer.

    Product
    Carestream Vue PACS; MX WEB SW/1 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retriev
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0189-2014·2013-11-20

    Baxter Recalls SIGMA SPECTRUM Infusion Pump LCD Screens for Discharge Failure

    Baxter Healthcare is recalling 346 SIGMA SPECTRUM Infusion Pump LCD screens that failed to withstand electrostatic discharge.

    Product
    SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision B) Product Usage: Intended to be used as a visual aid during the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0244-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0256-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; UPG MX-RAD SVR 7.5K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrie
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0276-2014·2013-11-20

    OrthoPediatrics Recalls 3.5mm Locking Screws Due to Packaging Labeling Error

    OrthoPediatrics Corp is recalling 3.5mm locking screws because the packaging description incorrectly identified them as 7.0mm screws, despite the correct part number.

    Product
    3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Femur Plating System combines implants and instruments in one convenient system. This system offers the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0245-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defect

    Carestream Health is recalling Vue PACS software because a defect may prevent some CT and MR images from loading in the viewer under specific conditions.

    Product
    Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0237-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 25K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrie
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0272-2014·2013-11-20

    Biotene Moisturizing Mouth Spray Recalled for Incorrect Ingredient Labeling

    GlaxoSmithKline is recalling Biotene Moisturizing Mouth Spray because the label lists sorbitol, but the product does not contain it.

    Product
    Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened with xylitol and sorbitol, GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108. Biotene Mouth Spray is used for the treatment of dry mouth
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0271-2014·2013-11-20

    Siemens syngo.plaza Image Processing System Recalled for Patient Data Merge Error

    Siemens is recalling 19 syngo.plaza image processing systems because a software function can cause unintended patient data merges when transferring data between systems.

    Product
    Siemens syngo.plaza image processing system image processing radiological system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0188-2014·2013-11-20

    Spacelabs elance Vital Signs Monitor Recalled Due to Sensor Connection Failure

    Spacelabs Healthcare is recalling 89 elance Vital Signs Monitors because they cannot connect to Spacelabs TruLink SpO2 sensors.

    Product
    Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0224-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defect

    Carestream Health is recalling Vue PACS software versions 11.3.2.0, 11.3.2.4, and 11.4 because specific multi-slice images may fail to load in the viewer.

    Product
    Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<7.5K EX/Y The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrie
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0246-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; UPG MX-O SVR 75K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0214-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defect

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; Virtual PWR Reading Basic SW, 8 Pack The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, ret
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0239-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 75K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrie
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0230-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defect

    Carestream Health is recalling Vue PACS software versions 11.3.2.0, 11.3.2.4, and 11.4 because specific multi-slice images may fail to load.

    Product
    Carestream Vue PACS; UNLIMITED READING LIC ADD 100K E/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrie
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0238-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer.

    Product
    Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 50K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrie
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0200-2014·2013-11-20

    Anspach Effort Recalls Pneumatic Systems Operating Manual and Product Catalog

    Anspach Effort, Inc. is correcting labeling on its Pneumatic Systems Operating Manual and Product Catalog because a claim regarding the device's capability to dissect biometals, bioplastics, and cement was found to be inaccurate.

    Product
    Product Catalog (part number 20-0020) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, all models and serial numbers. Product Usage: Indication for use is cutting an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0222-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defects

    Carestream Health is recalling Vue PACS software due to a defect that may prevent certain CT and MR images from loading in the viewer.

    Product
    Carestream Vue PACS; Unlimited Reading LIC<7.5K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0253-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defect

    Carestream Health is recalling Vue PACS software because a defect may prevent some CT and MR images from loading into the viewer under specific conditions.

    Product
    Carestream Vue PACS; MX WEB SW/10 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrie
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0240-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software due to a defect that may prevent some CT and MR images from loading in the viewer.

    Product
    Carestream Vue PACS; UPG MX-O SVR 7.5K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0225-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<15K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrie
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Food)·F-0133-2014·2013-11-20

    Specialty Enzymes Recalls Cellulase Products Due to Chloramphenicol Contamination

    Specialty Enzymes and Biotechnologies is recalling cellulase and protease products because they may contain low levels of chloramphenicol.

    Product
    Cellulase: ACTA 4-702 APEX 17-6262 APEX 6-9762 ARTH EB 10831 BETA GLUCANASE 1000 BROOK 8-352 CELLULASE 1000 CELLULASE 4000 CELLULASE CONC. CENTURY 7-152 CLENZSEB DIGESEB DIGESEB PB DIGESEB PLUS DIGESEB PLUS 401 DIGESEB SUPER DIGESEB SUPER 118 EB 10-14081 EB 1
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0131-2014·2013-11-20

    Dannon Recalls Light & Fit Nonfat Yogurt Due to Potential Yeast Contamination

    The Dannon Company is recalling Light & Fit Nonfat Yogurt because the product may contain yeast. The recall affects specific states and government facilities.

    Product
    Dannon LIGHT & FIT¿ Nonfat Yogurt - 4 PACK of 6 oz cups. Cherry UPC 36632 02180.
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0259-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; UPG MX-RAD SVR 50K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retriev
    Category
    Medical Device
    Distribution
    26 states
  • LowFDA (Devices)·Z-0198-2014·2013-11-20

    Anspach Effort Pneumatic Systems Operating Manual Labeling Correction

    Anspach Effort is correcting labeling on Pneumatic Systems Operating Manuals to remove unverified claims about cutting biometals, bioplastics, and cement.

    Product
    Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the Pneumatic Motor Systems including: BlackMax Motor Systems, MicroMax Systems and XMax Motor Systems all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereCPSC·14023·2013-11-19

    Viking Recalls Built-In Refrigerator Freezers Due to Fire Hazard

    Viking is recalling about 750 built-in side-by-side refrigerator freezers because electrical connectors can overheat, posing a fire hazard. Consumers should unplug the units and contact Viking for a free repair.

    Product
    Viking built-in side-by-side refrigerator freezers with in-door dispensers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·13V574000·2013-11-19

    Spartan Recalls 2013-2014 Utilimaster P80X Vehicles for Defrost Hose Issue

    Spartan Motors is recalling 586 Utilimaster P80X vehicles sold to UPS because a kinked coolant hose may prevent the windshield defrost system from working, reducing visibility.

    Product
    UTILIMASTER — UTILIMASTER P80X
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V575000·2013-11-19

    Space Craft Recalls Fifth Wheel Trailers Due to Door Lock Defect

    Space Craft is recalling 2006-2013 fifth wheel and travel trailers equipped with Fastec door locks that may jam, potentially trapping occupants inside.

    Product
    SPACE CRAFT — SPACE CRAFT FIFTH WHEEL TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V649000·2013-11-19

    Cruiser RV Recalls Trailers Due to Door Lock Jamming Hazard

    Cruiser RV is recalling 2006-2013 recreational trailers because a door lock defect may jam the deadbolt, potentially trapping occupants inside the vehicle.

    Product
    CRUISER RV — CRUISER RV RADIANCE, VIEWFINDER, SIGNATURE, ENTERRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V573000·2013-11-18

    Kenworth T800 and W900 Trucks Recalled for Brake System Defect

    PACCAR is recalling 2007-2014 Kenworth T800 and W900 trucks because brake chambers may take too long to apply or release, increasing crash risk.

    Product
    KENWORTH — KENWORTH W900, T800
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V572000·2013-11-18

    Suzuki Recalls 2013 SX4 Vehicles Due to Torque Converter Bolt Defect

    Suzuki is recalling 2013 SX4 vehicles with continuously variable transmissions because torque converter bolts may loosen, potentially causing the engine to stall and increasing crash risk.

    Product
    SUZUKI — SUZUKI SX4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V570000·2013-11-15

    BMW Recalls 2013 X3 xDrive Models for Instrument Panel Defect

    BMW is recalling 2013 X3 xDrive 28i/35i vehicles because a production error in the instrument panel could cause the airbag to deploy improperly during a crash.

    Product
    BMW — BMW X3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14020·2013-11-15

    Step2 Recalls Ride-On Wagon Toys Due to Fall Hazard

    Step2 is recalling about 14,000 Whisper Ride Touring Wagons because removable seat backs can detach, allowing children to fall out.

    Product
    Step2® Whisper Ride Touring Wagon™
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V571000·2013-11-14

    Honda Recalls 2014 Acura MDX AWD for Drive Shaft Bolt Issue

    Honda is recalling 2014 Acura MDX AWD vehicles because drive shaft bolts may not be properly tightened, which could allow the shaft to detach and increase crash risk.

    Product
    ACURA — ACURA MDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V568000·2013-11-14

    Volkswagen Recalls 2013-2014 Jetta Hybrid Vehicles for Gearbox Corrosion

    Volkswagen is recalling 2013-2014 Jetta Hybrid vehicles because gearbox corrosion may cause an electrical short and sudden loss of power, increasing crash risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN JETTA HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0111-2014·2013-11-13

    J M Smucker Recalls Cornmeal Products Due to Aflatoxin Levels

    J M Smucker is recalling specific lots of Martha White and White Lily cornmeal because aflatoxin levels exceeded FDA specifications.

    Product
    Martha White Buttermilk Cornmeal Self-Rising, White, Enriched NET WT 5 LB (2.26kg) Paper Bag Mfg Code 3152 511 BEST IF USED BY: 1-Feb-14; White Lily Buttermilk Cornmeal Self-Rising, White, Enriched NET WT 32 OZ (2 lb) 907g Paper Bag Mfg Code 3157 511 BEST IF USED BY: 6-Feb-14; M
    Category
    Food
    Distribution
    33 states
  • SevereFDA (Drugs)·D-66458-1·2013-11-13

    Sandoz Recalls Ropinirole Extended-Release Tablets Due to Cross-Contamination

    Sandoz is recalling specific lots of Ropinirole Extended-Release Tablets 2 mg due to potential cross-contamination with mycophenolate mofetil.

    Product
    Ropinirole, extended-release tablets, 2 mg, 90 count bottle, Rx only, Manufactured in India by Sandoz Private Ltd, for Sandoz Inc, Princeton, NJ 08540, NDC 0781-5780-92
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-66403-012·2013-11-13

    Mylan Recalls Amlodipine Besylate Tablets Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling Amlodipine Besylate Tablets 10 mg because they were produced with active ingredients not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate Tablets, USP 10 mg, packaged in a) 90-count bottles (NDC 0378-5210-77) and b) 500-count bottles (NDC 0378-5210-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-66403-002·2013-11-13

    Mylan Recalls Amlodipine and Benazepril Capsules Due to CGMP Deviations

    Mylan Pharmaceuticals is recalling specific lots of Amlodipine Besylate and Benazepril HCl capsules because they were not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate and Benazepril HCl Capsules, 2.5 mg/10 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A, NDC 0378-6895-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-66403-009·2013-11-13

    Mylan Recalls Amlodipine and Benazepril Capsules Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling Amlodipine Besylate and Benazepril HCl capsules because they were not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate and Benazepril HCl Capsules, 10mg/20mg, in 100 count bottles (NDC# 0378-6898-01) and 500 count bottles (NDC# 0378-6898-05) labeled in part ***Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.***
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0095-2014·2013-11-13

    American Laboratories Recalls Ultra Blend 102 Enzyme Powder Due to Contamination

    American Laboratories Inc is recalling Ultra Blend 102 enzyme powder due to potential Chloramphenicol contamination. The product was distributed to five states.

    Product
    Ultra Blend 102, powder, enzyme blend, packaged in 25 kg double poly bags inside fiber box. Product 73B, SI Item # 10678.
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-66403-005·2013-11-13

    Mylan Recalls Amlodipine Besylate Tablets Due to CGMP Deviations

    Mylan Pharmaceuticals is recalling Amlodipine Besylate Tablets, 5 mg, because they were produced with active ingredients not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate Tablets, USP, 5 mg, packaged in a) 90-count bottles (NDC 0378-5209-77) and b) 500-count bottles (NDC 0378-5209-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0118-2014·2013-11-13

    Irwin Naturals Recalls Dual Action Cleanse Due to Chloramphenicol Contamination

    Irwin Naturals is recalling Dual Action Cleanse and Daily Digestive Enzymes because they may be contaminated with chloramphenicol.

    Product
    Dual Action Cleanse by Cellular Research Formulas, 60 ct, Item AN027370, UPC 7 10363 27370 5, Item AN056592HFS, UPC 7 10363 56592 3; Item DR056439, UPC 7 10363 57369 0.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-66403-004·2013-11-13

    Mylan Recalls Ciprofloxacin Tablets Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling 521 bottles of Ciprofloxacin 250 mg tablets because they were not manufactured according to Good Manufacturing Practices.

    Product
    Ciprofloxacin Tablets, USP, 250 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-7097-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-66447-001·2013-11-13

    Irinotecan Hydrochloride Injection Recalled for Incorrect Formulation Calculation

    West-Ward Pharmaceutical Corp. is recalling Irinotecan Hydrochloride Injection because a calculation error resulted in drug levels higher than labeled.

    Product
    IRINOTECAN HYDROCHLORIDE — IRINOTECAN HYDROCHLORIDE (IRINOTECAN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0160-2014·2013-11-13

    Smiths Medical Recalls Portex Spinal Trays with Visual Particulate in Ampules

    Smiths Medical ASD, Inc. is recalling Portex Spinal Anaesthesia Trays because visual particulate was found in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection.

    Product
    Portex¿ Spinal Tray with Drugs 25g Whitacre; 15597-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar pu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-66403-003·2013-11-13

    Mylan Recalls Lamotrigine Tablets Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling 28,140 bottles of 200 mg Lamotrigine tablets because they were not manufactured according to Good Manufacturing Practices.

    Product
    Lamotrigine Tablets, USP, 200 mg, packaged in a) 60-count bottles (NDC 0378-4254-91) and b) 500-count bottles (NDC 0378-4254-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0116-2014·2013-11-13

    GE Pharma Recalls Creafuse Grape Due to DMAA Contamination

    GE Pharma LLC is recalling 480 units of Creafuse Grape, 600 Grams, because the product contains 1,3 dimethylamylamine (DMAA).

    Product
    Creafuse Grape, 600 Grams
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-66403-008·2013-11-13

    Mylan Recalls Amlodipine and Benazepril Capsules Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling specific lots of Amlodipine Besylate and Benazepril HCl capsules because they were not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-6899-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-66403-011·2013-11-13

    Mylan Recalls Ciprofloxacin Tablets Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling Ciprofloxacin 500 mg tablets because they were not manufactured according to Good Manufacturing Practices.

    Product
    Ciprofloxacin Tablets, USP, 500 mg,100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A, NDC 0378-7098-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-66318-001·2013-11-13

    Amgen Recalls Prolia Injection Due to Visible Cellulose Fibers

    Amgen is recalling 4,163 Prolia (denosumab) prefilled syringes because visible cellulose fibers were found during routine quality checks.

    Product
    PROLIA — PROLIA (DENOSUMAB)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-66403-010·2013-11-13

    Mylan Recalls Amlodipine and Benazepril Capsules Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling specific lots of Amlodipine Besylate and Benazepril HCl capsules because they were not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate and Benazepril HCl Capsules, 10 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-6900-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0113-2014·2013-11-13

    J M Smucker Recalls White Lily Corn Meal Due to Aflatoxin

    J M Smucker is recalling White Lily Corn Meal Self-Rising because aflatoxin levels exceeded FDA specifications in independent testing.

    Product
    White Lily Corn Meal Self-Rising, White, Enriched NET WT 5 lb (2.26kg) Paper Bag Mfg Code 3193 511 BEST IF USED BY: 12-Mar-14 Product labeled in part, INGREDIENTS: ENRICHED WHITE CORN MEAL, WHEAT FLOUR AND DEGERMINATED WHITE CORN MEAL***BAKING POWDER***SALT***CONTAINS: WHEAT ING
    Category
    Food
    Distribution
    33 states
  • SevereFDA (Food)·F-0094-2014·2013-11-13

    American Laboratories Recalls PC Blend 14 Enzyme Powder Due to Chloramphenicol

    American Laboratories Inc is recalling PC Blend 14 enzyme powder due to potential contamination with Chloramphenicol. The product was distributed to specific states.

    Product
    PC Blend 14, powder, enzyme blend, packaged in 9 kg and 25 kg double poly bags inside fiber box. Product 62A
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0117-2014·2013-11-13

    GE Pharma Recalls Creafuse Fruit Punch for DMAA Content

    GE Pharma LLC is recalling Creafuse Fruit Punch, 600 Grams, because the product contains 1,3 dimethylamylamine (DMAA).

    Product
    Creafuse Fruit Punch, 600 Grams
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0109-2014·2013-11-13

    Martha White Corn Meal Mix Recalled for Aflatoxin Levels

    J M Smucker Co is recalling Martha White Self-Rising Buttermilk Corn Meal Mix because independent testing found aflatoxin levels exceeding FDA specifications.

    Product
    Martha White¿ SELF-RISING BUTTERMILK CORN MEAL MIX White-Enriched Hot Rize NET WT 32 OZ (2 LB) 907g Paper Bag Mfg Code 3151 511 BEST IF USED BY: 31 JAN 14 Product labeled in part, INGREDIENTS: ENRICHED WHITE CORN MEAL, WHEAT FLOUR AND DEGERMINATED WHITE CORN MEAL***BAKING POWDER*
    Category
    Food
    Distribution
    33 states
  • HighFDA (Food)·F-0104-2014·2013-11-13

    Jim Dandy Enriched Quick Grits Recalled for Aflatoxin Contamination

    J M Smucker Co is recalling Jim Dandy Enriched Quick Grits because independent testing found aflatoxin levels exceeding FDA specifications.

    Product
    Jim Dandy¿ Enriched Quick Grits, 1lb paper box, Labeled in part INGREDIENTS: WHITE CORN GRITS***NACIN, THIAMIN, MONONITRATE, RIBOFLAVIN, FOLIC ACID. DISTRIBUTED BY: MARTHA WHITE FOODS, INC., P. O. BOX 751030 MEMPHIS, TN 38175***0 13300 12107 8***3143 511 BEST IF USED BY: 23-JAN-1
    Category
    Food
    Distribution
    33 states
  • HighFDA (Food)·F-0114-2014·2013-11-13

    Martha White Cornbread Recalled for Aflatoxin Contamination

    J M Smucker Co is recalling specific lots of Martha White Cotton Country Cornbread because aflatoxin levels exceeded FDA specifications.

    Product
    Martha White Cotton Country Cornbread, NET WT 6 OZ (170g) Paper Bag Mfg Code 3107 501 BEST IF USED BY: 17-Apr-14 Product labeled in part, INGREDIENTS: ENRICHED DEGERMINATED WHITE CORN MEAL, ENRICHED BLEACHED FLOUR***PARTIALLY HYDROGENATED SOYBEAN OIL, DEXTROSE, BAKING POWDER***
    Category
    Food
    Distribution
    33 states

Looking for a different month? Back to 2013.