The Recall Desk

Archive

July 2015 recalls

1,183 recalls were announced in July 2015.

What the numbers show

Critical
342
Severe
229
High
358
Moderate
233
Low
21

Of the 1,183 recalls this month scored against our rubric, 29% are Critical, 19% are Severe.

Which agencies issued them

101–200 of 1183

  • ModerateFDA (Drugs)·D-1266-2015·2015-07-29

    Wockhardt Recalls Famotodine Tablets Due to CGMP Deviations

    Wockhardt USA is recalling 539 drums of Famotodine Tablets, 20 mg, because the firm did not adequately investigate customer complaints.

    Product
    Famotodine Tablets, USP, 20 mg Tablets, For Repacking Only, Packaged in 6500 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0374-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2207-2015·2015-07-29

    Siemens Recalls ADVIA Centaur Tni-Ultra Assay Due to System Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Tni-Ultra Assay kits due to system-to-system bias between different ADVIA Centaur platforms.

    Product
    ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500 tests Product Usage: For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur/ADVIA Centaur XP/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1260-2015·2015-07-29

    Wockhardt Recalls Lisinopril Tablets Due to Complaint Investigation Failures

    Wockhardt USA is recalling specific lots of Lisinopril 30 mg tablets because the firm did not adequately investigate customer complaints.

    Product
    Lisinopril Tablets USP, 30 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-953-01) and B) 500 Count Bottles (NDC: 64679-953-05), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1273-2015·2015-07-29

    Wockhardt Recalls Zonisamide Capsules Due to Complaint Investigation Failures

    Wockhardt USA is recalling 84,542 bottles of Zonisamide 50 mg capsules because the firm did not adequately investigate customer complaints.

    Product
    Zonisamide Capsules, 50 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0946-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1259-2015·2015-07-29

    Wockhardt Recalls Lisinopril Tablets Due to CGMP Deviations

    Wockhardt USA Inc. is recalling Lisinopril Tablets USP, 20 mg, due to inadequate investigation of customer complaints. The recall covers nationwide distribution.

    Product
    Lisinopril Tablets USP, 20 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-941-01), B) 500 Count Bottles (NDC: 64679-941-05), and C) 1000 Count Bottles (NDC: 64679-941-06), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2180-2015·2015-07-29

    FDA Recalls Fiber Stripper Tools Due to Cleaning Validation Issues

    American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Tool, Stripper W/BLD, 44S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2169-2015·2015-07-29

    American Medical Systems Recalls Fiber Stripper Due to Sterilization Validation Issues

    American Medical Systems is recalling Fiber Strippers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Fiber Stripper, 910¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1249-2015·2015-07-29

    Wockhardt Recalls Clarithromycin Tablets Due to Complaint Investigation Failures

    Wockhardt USA is recalling 59,729 bottles of Clarithromycin 500 mg tablets because the firm did not adequately investigate customer complaints.

    Product
    Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-949-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2149-2015·2015-07-29

    Gardner Denver MEDI-PUMP Aspirator Recalled for Performance Defects

    Gardner Denver Thomas Inc. is recalling 160 MEDI-PUMP Aspirators because the vacuum pump may not perform to specification.

    Product
    THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1240 Product Usage: medical aspirator
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2125-2015·2015-07-29

    Perkinelmer WIZARD2 Gamma Counter Recalled for Barcode Label Error

    Perkinelmer is recalling 53 WIZARD2 gamma counters because a barcode label error may produce erroneous results.

    Product
    WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1267-2015·2015-07-29

    Wockhardt Recalls Famotidine Tablets Due to Complaint Investigation Failures

    Wockhardt USA LLC is recalling 1,002 drums of Famotidine Tablets, USP, 10 mg because the firm did not adequately investigate customer complaints.

    Product
    Famotodine Tablets, USP, 10 mg Tablets, For Repacking Only, Packaged in 50,000 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0972-00.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2129-2015·2015-07-29

    Perkin Elmer WIZARD2 Gamma Counters Recalled for Barcode Label Error

    Perkinelmer is recalling 18 WIZARD2 gamma counters because a barcode label error may produce erroneous results.

    Product
    Perkin Elmer WIZARD2 10-detector, 1000 samples Product Code: 2470-0200, 3470-0200 The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2157-2015·2015-07-29

    FDA Recalls Sureflex 200 Lithotripsy Fibers Due to Sterilization Validation Issues

    American Medical Systems is recalling Sureflex 200 Lithotripsy Fibers because validation data for cleaning and sterilization methods does not meet FDA guidance for reusable products.

    Product
    Sureflex 200 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1244-2015·2015-07-29

    Wockhardt Recalls Lisinopril Tablets Due to Complaint Investigation Failures

    Wockhardt USA is recalling specific lots of Lisinopril 2.5 mg tablets because the manufacturer did not adequately investigate customer complaints.

    Product
    Lisinopril Tablets USP, 2.5 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-927-01) and B) 500 Count Bottles (NDC: 64679-927-05), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1276-2015·2015-07-29

    Wockhardt Recalls Captopril Tablets Due to Inadequate Complaint Investigation

    Wockhardt USA is recalling Captopril 50 mg tablets because the manufacturer did not adequately investigate customer complaints.

    Product
    Captopril Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0904-01) and B) 1000 Count Bottles (NDC: 64679-0904-02), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2148-2015·2015-07-29

    EKOS EkoSonic Control Unit Recalled Due to Cable Recognition Failure

    EKOS Corporation is recalling 46 EkoSonic Control Units because the Connector Interface Cable was not recognized by the PT-3B control unit.

    Product
    The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular Device. The EkoSonic Endovascular System consists of three main components: -a single use EkoSonic Endovascular Device which is comprised
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2099-2015·2015-07-29

    Stryker Neptune 2 Waste Management System Recalled for Diverter Valve Failures

    Stryker is recalling the Neptune 2 Waste Management System due to installation failures of the diverter valve assembly during docking.

    Product
    0702-001-350Q, Diverter Valve Assembly 0702-001-000, Neptune 2 Rover Ultra (120V) 0702-001-000R, Repair Neptune 2 Rover 0702-002-000, Neptune 2 Rover Ultra (230V) 0702-002-000ES, Neptune 2 Rover (230V) Spanish 0702-002-000FI, Neptune 2 Ultra Rover (230V) Finnish 0702-002-0
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-2168-2015·2015-07-29

    American Medical Systems Recalls Fiber Stripper Due to Sterilization Validation Issues

    American Medical Systems is recalling Fiber Strippers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Fiber Stripper, 550¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2204-2015·2015-07-29

    Philips Recalls Head Holders for Ingenuity Core 128 CT Systems

    Philips Medical Systems is recalling 55 head holders shipped with Ingenuity Core 128 CT systems because they were not qualified for use on this specific model.

    Product
    Head Holder shipped with Ingenuity Core 128 Computed Tomography X-ray Systems. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    32 states
  • ModerateFDA (Drugs)·D-1252-2015·2015-07-29

    Wockhardt Recalls Metoprolol Succinate Extended-Release Tablets Due to CGMP Deviations

    Wockhardt USA Inc. is recalling specific lots of Metoprolol Succinate Extended-Release Tablets because the firm did not adequately investigate customer complaints.

    Product
    Metoprolol Succinate Extended-Release Tablets, USP, 200 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0737-02) and B) 500 Count Bottles (NDC: 64679-0737-03), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1257-2015·2015-07-29

    Wockhardt Recalls Lisinopril Tablets Due to Inadequate Complaint Investigation

    Wockhardt USA is recalling specific lots of Lisinopril 5 mg tablets because the firm did not adequately investigate customer complaints.

    Product
    Lisinopril Tablets USP, 5 mg Tablets,Packaged in A) 100 Count Bottles (NDC: 64679-928-01), B) 500 Count Bottles (NDC: 64679-928-05), and C) 1000 Count Bottles (NDC: 64679-928-06), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Wat
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1262-2015·2015-07-29

    Wockhardt Recalls Zolpidem Tartrate Tablets Due to Complaint Investigation Failures

    Wockhardt USA is recalling Zolpidem Tartrate 10 mg tablets because the company did not adequately investigate customer complaints, a violation of current Good Manufacturing Practices.

    Product
    Zolpidem Tartrate Tablets, 10 mg Tablets, CIV, Packaged in A) 100 Count Bottles (NDC: 64679-715-01) and B) 500 Count Bottles (NDC: 64679-715-04), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 0705
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2184-2015·2015-07-29

    FDA Recalls American Medical Systems Fiber Strippers Due to Sterilization Validation Issues

    American Medical Systems is recalling 16,710 disposable fiber strippers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Stripper, 0.6mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1246-2015·2015-07-29

    Wockhardt Recalls Extended Phenytoin Sodium Capsules Due to CGMP Deviations

    Wockhardt USA is recalling 53,894 bottles of Extended Phenytoin Sodium Capsules because the firm did not adequately investigate customer complaints.

    Product
    Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules, Packaged as A) 100 Count Bottles (NDC: 64679-720-01) and B) 1000 Count Bottles (NDC: 64679-720-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippan
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2182-2015·2015-07-29

    FDA Recalls Fiber Stripper Tools Due to Cleaning Validation Issues

    American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Tool, Stripper W/BLD, 28S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1270-2015·2015-07-29

    Wockhardt Recalls Metoprolol Succinate Extended-Release Tablets Due to CGMP Deviations

    Wockhardt USA Inc. is recalling Metoprolol Succinate Extended-Release Tablets, 100 mg, because the firm did not adequately investigate customer complaints.

    Product
    Metoprolol Succinate Extended-Release Tablets, USP, 100 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0736-02), B) 500 Count Bottles (NDC: 64679-0736-03), and C) 12 x 30 Tablet Dispenser Pack Cartons (NDC: 64679-0736-09), Rx Only. Manufactured by: Wockhardt Limited, Mu
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2155-2015·2015-07-29

    Cochlear Nucleus Sterile Silicone Template Recalled for Expiration

    Cochlear Americas is recalling 26 units of Nucleus Sterile Silicone Templates because expired product was distributed to specific US states.

    Product
    Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the sterile field to check the size of the periosteal pocket, the shape and depth of the implant well and appropriate positions for tie down holes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1269-2015·2015-07-29

    Wockhardt Recalls Lansoprazole Capsules Due to Inadequate Complaint Investigation

    Wockhardt USA is recalling specific lots of Lansoprazole Delayed-Release Capsules because the manufacturer did not adequately investigate customer complaints.

    Product
    Lansoprazole Delayed-Release Capsules, USP, 30 mg Capsules, Packaged in A) 30 Count Bottles (NDC: 64679-0670-01), B) 90 Count Bottles (NDC: 64679-0670-07), and C) 1000 Count Bottles (NDC: 64679-0670-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by:
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2171-2015·2015-07-29

    FDA Recalls Fiber Cleavers Due to Sterilization Validation Issues

    American Medical Systems is recalling 16,710 Fiber Cleavers because cleaning and sterilization validation data do not meet FDA guidance for reusable medical devices.

    Product
    1X1 Cleaving Tiles; The Fiber Cleaver is a reusable and sterilizable tool used to score the outer jacket on Endostat and SureFlex Fibers. The tool is a one piece pencil-like design with a sharpened blade at the end. The Fiber Cleaver is a SureFlex TM Reusable Laser Lithotri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2159-2015·2015-07-29

    FDA Recalls Sureflex 365 Lithotripsy Fibers Due to Sterilization Validation Issues

    American Medical Systems is recalling 16,710 Sureflex 365 Lithotripsy Fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Sureflex 365 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1272-2015·2015-07-29

    Wockhardt Recalls Metoprolol Succinate Tablets Due to Complaint Investigation Failures

    Wockhardt USA is recalling Metoprolol Succinate Extended-Release Tablets because the firm did not adequately investigate customer complaints.

    Product
    Metoprolol Succinate Extended-Release Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0734-02), B) 500 Count Bottles (NDC: 64679-0734-03), C) 8000 Count Pouches, For Repacking Only (NDC: 64679-734-08) and D) 12 x 30 Tablet Dispenser Pack Cartons (NDC: 64
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2101-2015·2015-07-29

    Cook Inc. Recalls Flexor RTPS Guiding Sheaths Due to Dilator Length Complaints

    Cook Inc. is voluntarily recalling Flexor RTPS Guiding Sheaths and Ring Transjugular Intrahepatic Access Sets because users reported the included dilators were too long.

    Product
    Flexor RTPS Guiding Sheath Product Usage: The Flexor RTPS Guiding Sheaths are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices. These curved sheaths are manufactured from material incorporating a stainl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1274-2015·2015-07-29

    Wockhardt Recalls Zonisamide Capsules Due to Inadequate Complaint Investigation

    Wockhardt USA is recalling Zonisamide Capsules, 25 mg, because the firm did not adequately investigate customer complaints.

    Product
    Zonisamide Capsules, 25 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0945-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1251-2015·2015-07-29

    Wockhardt Recalls 15 mg Lansoprazole Capsules Due to Complaint Investigation Failures

    Wockhardt USA is recalling 848 pouches of 15 mg Lansoprazole Delayed-Release Capsules because the firm did not adequately investigate customer complaints.

    Product
    Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, For Repackaging Only, Packaged in 4500 Count Pouches, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-140-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2126-2015·2015-07-29

    Perkinelmer Recalls WIZARD2 Gamma Counters Due to Barcode Label Error

    Perkinelmer is recalling 53 WIZARD2 gamma counters because a barcode label error may produce erroneous results.

    Product
    WIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050 The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1248-2015·2015-07-29

    Wockhardt Recalls Azithromycin Tablets Due to Complaint Investigation Failures

    Wockhardt USA Inc. is recalling Azithromycin Tablets, USP, 250 mg because the firm did not adequately investigate customer complaints.

    Product
    Azithromycin Tablets, USP, 250 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0961-01), B) 3,500 Count Pouches (NDC: 64679-961-08), and C) 3 x 6 Tablet Card Cartons (NDC: 64679-961-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhard
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2205-2015·2015-07-29

    Philips Recalls Head Holders Shipped with Ingenuity CT Systems

    Philips Medical Systems is recalling 66 head holders shipped with Ingenuity CT systems because they were not qualified for use on this specific model.

    Product
    Head Holder shipped with Ingenuity CT Computed Tomography X-ray Systems
    Category
    Medical Device
    Distribution
    32 states
  • ModerateFDA (Drugs)·D-1265-2015·2015-07-29

    Wockhardt Recalls Famotodine Tablets Due to Complaint Investigation Failures

    Wockhardt USA is recalling Famotodine Tablets 20 mg because the company did not adequately investigate customer complaints, a CGMP deviation.

    Product
    Famotodine Tablets, USP, 20 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-936-01), B) 100 Count Bottles(NDC: 64679-936-02), and C) 1000 Count Bottles (NDC: 64679-936-03), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1277-2015·2015-07-29

    Wockhardt Recalls Captopril Tablets Due to Complaint Investigation Failures

    Wockhardt USA is recalling 68,969 bottles of Captopril 100 mg tablets because the firm did not adequately investigate customer complaints.

    Product
    Captopril Tablets, USP, 100 mg Tablets, Packaged in 100 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0905-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2124-2015·2015-07-29

    Perkin Elmer WIZARD2 Gamma Counter Recalled for Barcode Label Error

    Perkinelmer is recalling 63 WIZARD2 gamma counters worldwide due to a barcode label error that may produce erroneous results.

    Product
    Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2103-2015·2015-07-29

    Allergan Recalls Natrelle Tissue Expanders Due to Expired Shelf Life

    Allergan is recalling Natrelle 133 and CUI Series Tissue Expanders because the shipped products were beyond their 47-month shelf life.

    Product
    Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2208-2015·2015-07-29

    Silhouette Suture Brochure Recalled for Incomplete Risk Information

    Silhouette Lift, Inc. is recalling Silhouette Suture brochures because they omit a complete list of risks and side effects, potentially misleading patients about product safety.

    Product
    Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to fixate the cheek subdermis in an elevated position.
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-2181-2015·2015-07-29

    FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues

    American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Tool, Stripper W/BLD, 44S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, correspond
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2150-2015·2015-07-29

    Gardner Denver MEDI-PUMP Aspirator Recalled for Performance Defects

    Gardner Denver Thomas Inc is recalling 370 units of the MEDI-PUMP Aspirator, Model 1242, because the vacuum pump may not perform to specification.

    Product
    THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1242 Product Usage: medical aspirator
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1256-2015·2015-07-29

    Wockhardt Recalls Amlodipine Besylate Tablets Due to CGMP Deviations

    Wockhardt USA is recalling Amlodipine Besylate 10 mg tablets because the firm did not adequately investigate customer complaints.

    Product
    Amlodipine Besylate Tablets, 10 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-423-01) and B) 1000 Count Bottles (NDC: 64679-423-02, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 U
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1255-2015·2015-07-29

    Wockhardt Recalls Amlodipine Besylate Tablets Due to CGMP Deviations

    Wockhardt USA is recalling Amlodipine Besylate 5 mg tablets because the firm did not adequately investigate customer complaints.

    Product
    Amlodipine Besylate Tablets, 5 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-422-01) and B) 1000 Count Bottles (NDC: 64679-422-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1258-2015·2015-07-29

    Wockhardt Recalls Lisinopril Tablets Due to Inadequate Complaint Investigation

    Wockhardt USA is recalling Lisinopril 10 mg tablets because the firm did not adequately investigate customer complaints. The recall covers multiple lot numbers distributed nationwide.

    Product
    Lisinopril Tablets USP, 10 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-929-01), B) 500 Count Bottles (NDC: 64679-929-05), and C) 1000 Count Bottles (NDC: 64679-929-06), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 W
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1254-2015·2015-07-29

    Wockhardt Recalls Zonisamide Capsules Due to Inadequate Complaint Investigation

    Wockhardt USA LLC is recalling 491,360 bottles of Zonisamide Capsules, 100 mg, because the firm did not adequately investigate customer complaints.

    Product
    Zonisamide Capsules, 100 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0990-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2183-2015·2015-07-29

    FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues

    American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Tool, Stripper W/BLD, 28S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, correspond
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2163-2015·2015-07-29

    FDA Recalls Sure F!ex Laser Fibers Due to Cleaning Validation Issues

    American Medical Systems is recalling 16,710 Sure F!ex laser fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    365¿M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resecti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2158-2015·2015-07-29

    FDA Recalls Sureflex 273 Lithotripsy Fibers Due to Cleaning Validation Issues

    American Medical Systems is recalling Sureflex 273 Lithotripsy Fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Sureflex 273 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1275-2015·2015-07-29

    Wockhardt Recalls Captopril Tablets Due to CGMP Deviations

    Wockhardt USA is recalling Captopril Tablets, USP, 25 mg due to inadequate investigation of customer complaints.

    Product
    Captopril Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0903-01) and B) 1000 Count Bottles (NDC: 64679-0903-02), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2165-2015·2015-07-29

    Fiber Stripper Recalled for Cleaning and Sterilization Validation Issues

    American Medical Systems is recalling Fiber Strippers because validation data for cleaning and sterilization methods does not meet FDA guidance for reusable products.

    Product
    Fiber Stripper, 200¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2151-2015·2015-07-29

    Gardner Denver Thomas Recalls Medi-Pump Aspirators Due to Performance Issues

    Gardner Denver Thomas is recalling 508 Medi-Pump aspirators because the vacuum pump may not perform to specification.

    Product
    THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1243 Product Usage: medical aspirator
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1243-2015·2015-07-29

    Wockhardt Recalls Amlodipine Besylate Tablets Due to CGMP Deviations

    Wockhardt USA LLC is recalling Amlodipine Besylate 2.5 mg tablets because the firm did not adequately investigate customer complaints.

    Product
    Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-421-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2172-2015·2015-07-29

    FDA Recalls Fiber Stripper Tools Due to Cleaning Validation Issues

    American Medical Systems is recalling Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Tool, StripperW/BLD, 10S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2098-2015·2015-07-29

    CooperSurgical Recalls Milex Vaginal-Hymenal Silicone Dilators Due to Labeling Error

    CooperSurgical is recalling 40 kits of Milex Vaginal-Hymenal Silicone Dilators because the outer carton labels contain an incorrect expiration date.

    Product
    Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage: The CooperSurgical Milex Vaginal-Hymenal Silicone Dilators are used for progressive vaginal dilation therapy involving the treatment of vaginismus (muscular spasm of the vagina) and conditions that re
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1271-2015·2015-07-29

    Wockhardt Recalls Metoprolol Succinate Tablets Due to CGMP Deviations

    Wockhardt USA Inc. is recalling Metoprolol Succinate Extended-Release Tablets because the firm did not adequately investigate customer complaints.

    Product
    Metoprolol Succinate Extended-Release Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0735-02), B) 500 Count Bottles (NDC: 64679-0735-03), C) 4000 Count Pouches, For Repacking Only (NDC: 64679-0735-08), and D) 12 x 30 Tablet Dispenser Pack Cartons (NDC:
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2147-2015·2015-07-29

    CooperSurgical Recalls Infant Heel Warmers for Lack of FDA Clearance

    CooperSurgical is recalling infant heel warmers sold under CooperSurgical and Fisher brands because they were marketed without FDA 510(k) clearance.

    Product
    Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and Fisher brand as follows : CooperSurgical PN 20418 WARMGEL INFANT HEEL WARMER - PRISM BOX OF 100; PN 24401 LIQUID INFANT HEEL WARMER - PRISM BOX OF 100; and Fisher Brand. PN 24647 FISHER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1263-2015·2015-07-29

    Wockhardt Recalls Azithromycin Tablets Due to Complaint Investigation Failures

    Wockhardt USA LLC is recalling Azithromycin Tablets, USP, 500 mg because the firm did not adequately investigate customer complaints.

    Product
    Azithromycin Tablets, USP, 500 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0964-01) and B) 3 x 3 Tablet Card Cartons (NDC: 64679-964-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2203-2015·2015-07-29

    Philips Recalls Head Holders for Ingenuity Core CT Systems

    Philips is recalling 79 head holders shipped with Ingenuity Core CT systems because they were not qualified for use on this specific model.

    Product
    Head Holder shipped with Ingenuity Core Computed Tomography X-ray Systems. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    32 states
  • ModerateFDA (Devices)·Z-2104-2015·2015-07-29

    Allergan Recalls Natrelle Tissue Expanders for Expired Shelf Life

    Allergan is recalling Natrelle CUI Series Tissue Expanders because the shipped products were beyond their shelf life. The recall involves 23 units total, with 16 distributed in the US.

    Product
    Natrelle CUI Series Tissue Expanders. Product Usage: Natrelle CUI Series Tissue Expander has been designed for temporary implantation to develop a skin flap. The device is used for reconstructive correction of a defect or to provide cover for a prosthetic implant. The CUI Tis
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2130-2015·2015-07-29

    Perkin Elmer WIZARD2 Gamma Counter Recalled for Barcode Label Error

    Perkinelmer is recalling 179 WIZARD2 gamma counters because a barcode label error may produce erroneous results.

    Product
    Perkin Elmer WIZARD2 1-detector,3", 1000 samples Product Code: 2480-0010 The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2127-2015·2015-07-29

    Perkin Elmer WIZARD2 Gamma Counters Recalled for Barcode Label Error

    Perkinelmer is recalling 54 WIZARD2 gamma counters worldwide due to a barcode label error that may produce erroneous results.

    Product
    Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100 The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2164-2015·2015-07-29

    FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues

    American Medical Systems is recalling Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Fiber Stripper, 150¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2160-2015·2015-07-29

    FDA Recalls Sureflex 550 Lithotripsy Fibers Due to Sterilization Validation Issues

    American Medical Systems is recalling Sureflex 550 Lithotripsy Fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Sureflex 550 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1253-2015·2015-07-29

    Wockhardt Recalls Tamsulosin Hydrochloride Capsules Due to CGMP Deviations

    Wockhardt USA Inc. is recalling Tamsulosin Hydrochloride Capsules because the firm did not adequately investigate customer complaints, a Current Good Manufacturing Practice (CGMP) deviation.

    Product
    Tamsulosin Hydrochloride Capsules, USP*, 0.4 mg Capsules, Packaged in A) 100 Count Bottles (NDC: 64679-516-02) and B) 500 Count Bottles (NDC: 64679-516-03), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2100-2015·2015-07-29

    Cook Inc. Recalls Ring Transjugular Intrahepatic Access Set Due to Dilator Length

    Cook Inc. is voluntarily recalling 661 Ring Transjugular Intrahepatic Access Sets and Flexor RTPS Introduce Sheaths because the dilators are too long.

    Product
    Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transjugular Intrahepatic Access Sets are intended for transjugular liver access in diagnostic and interventional procedures. The Ring Transjugular Intrahepatic Access Set consists of the following components:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2186-2015·2015-07-29

    FDA Recalls American Medical Systems Fiber Strippers for Validation Issues

    American Medical Systems is recalling 16,710 disposable fiber strippers because cleaning and sterilization validation data do not meet new FDA guidance for reusable products.

    Product
    Stripper, 0.3mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2096-2015·2015-07-29

    Safety PICC Insertion Tray Recalled for Incorrect Non-Sterile Packaging Item

    Custom Healthcare Systems is recalling Safety PICC Insertion Trays because the outer packaging contains an incorrect non-sterile saline flush syringe.

    Product
    Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-2192-2015·2015-07-29

    Hardy Diagnostics Recalls HardyCHROM VRE Agar Due to Lack of Clearance

    Hardy Diagnostics is recalling HardyCHROM VRE Agar because it lacks FDA 510(k) clearance. The product was distributed to one customer in South Carolina.

    Product
    HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage 2 to 8 degrees C on receipt Chromogenic medium for stool pathogen screening.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-2201-2015·2015-07-29

    Myoscience iovera Smart Tip Recalled for Incorrect Expiration Date Labeling

    Myoscience Inc. is recalling iovera 155 Smart Tips because the expiration dates on the outer boxes and pouches are incorrect.

    Product
    iovera 155 Smart Tip; Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count respectively) iovera Smart Tips are individually packaged in Tyvek PET pouches, which are then packaged into 5 or 10 pack boxes and shipper boxes. Product Usage: Cyrogenic Surgical Device Th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1278-2015·2015-07-29

    Purdue Pharma Recalls Intermezzo Sublingual Tablets for Dissolution Failures

    Purdue Pharma is recalling Intermezzo (zolpidem tartrate) sublingual tablets because they failed to meet dissolution specifications.

    Product
    Intermezzo (zolpidem tartrate), sublingual tablet 3.5 mg, 1 tablet per pouch, 30 pouches per carton, Rx only, Distributed by Purdue Pharma L.P. Stamford, CT 06901-3431, NDC 59011-265-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V470000·2015-07-28

    Chrysler Recalls 2015 Chrysler 200 Vehicles for Electrical Connector Defect

    Chrysler is recalling 77,971 model year 2015 Chrysler 200 vehicles because a defective electrical connector may cause intermittent power failures, potentially leading to the vehicle stalling without warning.

    Product
    CHRYSLER — CHRYSLER 200
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V473000·2015-07-28

    Altec Recalls 2006-2015 Aerial Devices Due to Outrigger Interlock Defect

    Altec Industries is recalling 2,514 aerial devices from 2006-2015 because the outrigger interlock system may fail to detect proper deployment, risking boom instability and injury.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V477000·2015-07-28

    Newmar Recalls Toy Haulers Due to Unprotected Fuel System Fire Risk

    Newmar is recalling specific All Star and Canyon Star toy haulers because unprotected plastic wrap around the fuel system could burn if exposed to an ignition source.

    Product
    NEWMAR — NEWMAR ALL STAR, CANYON STAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V472000·2015-07-28

    Honda Recalls 2016 HR-V Vehicles for Missing Tire Placard

    Honda is recalling 11,511 model year 2016 HR-V vehicles because they may be missing the required tire and loading information placard.

    Product
    HONDA — HONDA HR-V
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V468000·2015-07-27

    Chrysler Recalls 2015 Ram 4500 and 5500 Trucks for Suspension Defect

    Chrysler is recalling 199 model year 2015 Ram 4500 and 5500 pickup trucks due to a front suspension weld defect that may reduce vehicle stability and increase crash risk.

    Product
    RAM — RAM 5500, 4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V467000·2015-07-27

    Dodge Charger Recall for Overly Sensitive Side Impact Sensors

    Chrysler is recalling 2011-2014 Dodge Chargers because overly sensitive side impact sensors may cause air bags to deploy unexpectedly, increasing crash risk.

    Product
    DODGE — DODGE CHARGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V462000·2015-07-24

    Forest River Recalls 2007-2015 Glaval Bus Titan II for Electrical Fire Risk

    Forest River is recalling 2007-2015 Glaval Bus Titan II vehicles due to a misrouted electrical cable that may cause a loose connection or arching, increasing the risk of a vehicle fire.

    Product
    GLAVAL BUS — GLAVAL BUS TITAN II
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V464000·2015-07-24

    Ford Recalls 2015-2016 Vehicles Due to Parking Brake Defect

    Ford is recalling specific 2015-2016 models because the parking brake may not fully engage, increasing the risk of the vehicle rolling away on a slope.

    Product
    FORD — FORD, LINCOLN EXPLORER, MKT, MKS, FLEX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V463000·2015-07-24

    General Motors Recalls 2013-2016 Cadillac ATS for Sunroof Defect

    General Motors is recalling 2013-2016 Cadillac ATS vehicles because the sunroof may close automatically if the switch is pressed inadvertently, posing a risk of personal injury.

    Product
    CADILLAC — CADILLAC ATS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·104-2015·2015-07-23

    Brown Packing Recalls Veal Trimmings Due To Possible E. Coli Contamination

    Brown Packing Company is recalling raw veal trimmings that may be contaminated with E. coli O157:H7 and non-O157 STEC. No illnesses have been reported.

    Product
    Brown Packing Recalls Veal Products Due To Possible E. Coli Contamination
    Category
    Food
    Distribution
    8 states
  • HighCPSC·15196·2015-07-23

    UPPAbaby Recalls 2015 Strollers and RumbleSeats Due to Choking Hazard

    UPPAbaby is recalling 2015 CRUZ and VISTA strollers and RumbleSeats because the foam bumper bar can break off, posing a choking hazard to children.

    Product
    UPPAbaby 2015 CRUZ, 2015 VISTA strollers and 2015 RumbleSeat
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·15V461000·2015-07-23

    Chrysler Recalls 2013-2015 Vehicles for Radio Software Vulnerability

    Chrysler is recalling specific 2013-2015 Ram, Jeep, Dodge, and Chrysler vehicles because radio software vulnerabilities allow unauthorized remote access to vehicle control systems, increasing crash risk.

    Product
    RAM — RAM, JEEP, DODGE 5500, 1500, CHEROKEE, VIPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15197·2015-07-23

    Briggs & Stratton Recalls Simplicity Riding Mowers Due to Projectile Risk

    Briggs & Stratton is recalling about 2,800 Simplicity riding mowers and garden tractors because the chute deflector can fail, posing a risk of injury from projectiles.

    Product
    Briggs & Stratton Simplicity Riding Mowers, Garden Tractors and Mower Decks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·15195·2015-07-23

    Husqvarna Recalls Lawn Tillers Due to Unintended Movement Risk

    Husqvarna is recalling approximately 24,000 Ariens, Husqvarna, Jonsered, and Poulan Pro tillers because the transmission shift rod can cause the machine to move unintentionally, posing a risk of injury.

    Product
    Lawn and garden tillers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·15743·2015-07-23

    Polaris Recalls Youth RZR Vehicles Due to Fuel Pump Fire Hazard

    Polaris is recalling about 4,300 Youth RZR 170 EFI vehicles because a fuel pump retaining ring can leak, posing a fire hazard.

    Product
    Polaris Youth RZR recreational off-highway vehicle
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V457000·2015-07-22

    Kenworth Trucks Recalled for Reversed Air Brake Line Installation

    PACCAR is recalling 2016 Kenworth trucks because reversed air brake lines may prevent the redundant braking system from working correctly during a failure.

    Product
    KENWORTH — KENWORTH T660, T680, T880, T440
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2063-2015·2015-07-22

    Elekta MOSAIQ Oncology Software Recalled for Incorrect Stereotactic Field Size

    Elekta is recalling MOSAIQ Oncology Information System software due to a defect that sends incorrect field sizes to treatment machines for stereotactic plans using cones.

    Product
    MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Drugs)·D-1236-2015·2015-07-22

    Kremers Urban Recalls Nitroglycerin Patches Due to Impurity Failure

    Kremers Urban Pharmaceuticals is recalling Nitroglycerin Transdermal Systems because they failed impurity specifications during stability testing.

    Product
    Nitroglycerin Transdermal System 0.2 mg/hr (10 cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only, Manufactured for: Kremers Urban Pharmaceuticals Inc., Princeton, NJ, 08540, USA, By LTS Lohmann Therapie Systeme AG, Anderach, Federal Republic of Germany, NDC 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2082-2015·2015-07-22

    FDA Recalls Autopen Classic Automatic Insulin Delivery Pens Due to Dial Defect

    Owen Mumford USA is recalling Autopen Classic Automatic insulin delivery pens because the dose dial fails to stay set, preventing patients from administering their medication.

    Product
    Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-sterile automatic subcutaneous injection device which delivers insulin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2060-2015·2015-07-22

    Zimmer Recalls ZNN Antegrade Femoral Nail Due to Potential Denting

    Zimmer, Inc. is recalling eight ZNN Antegrade Femoral Nail units because a single distributed unit may have been dented, posing a risk of implant fatigue.

    Product
    ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device.
    Category
    Medical Device
    Distribution
    2 states

Looking for a different month? Back to 2015.