The Recall Desk

Archive

December 2015 recalls

614 recalls were announced in December 2015.

What the numbers show

Critical
17
Severe
215
High
208
Moderate
133
Low
41

Of the 614 recalls this month scored against our rubric, 3% are Critical, 35% are Severe.

1–100 of 614

  • HighUSDA FSIS·150-2015·2015-12-31

    Jafflz Sandwiches Recalled Due to Cooling Process Deviation

    Du Monde Gourmet is recalling Jafflz pocket sandwiches due to a possible cooling process deviation that could allow harmful bacteria to grow.

    Product
    Jafflz LLC — Du Monde Gourmet Recalls Jafflz Sandwich Products Due To Possible Cooling/Process Deviation
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·15V890000·2015-12-31

    Compass Recalls Horse Trailers with Defective Water Heaters

    Compass Conversions is recalling specific 2014 and 2015 horse trailers due to a gas valve defect that may cause water to overheat, posing a scalding risk.

    Product
    PLATINUM — PLATINUM, BLOOMER HORSE TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0442-2016·2015-12-30

    Biomerieux Etest PIP/TAZO/CON-4 PTC 256 Recalled for Erroneous Results

    Biomerieux is recalling Etest PIP/TAZO/CON-4 PTC 256 antimicrobial susceptibility tests due to the potential for reporting false susceptible results for Piperacillin/Tazobactam.

    Product
    Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests US. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0286-2016·2015-12-30

    United Trading Center Recalls Golden Medium Raisins for Undeclared Sulfites

    United Trading Center Inc. is recalling 6 cases of Golden Medium Raisins because they contain undeclared sulfites. The product was distributed in New York and Pennsylvania.

    Product
    TRC Golden Medium Raisins Packed by: The Raisin Company (PTY) LTD FActory AT: Noagspaal, Marchand, South Africa PO BOx 77, Marchand 8873 Produce of South Africa
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0482-2016·2015-12-30

    Cardica Recalls MicroCutter Xchange 30 Blue Cartridges Due to Firing Defect

    Cardica, Inc. is recalling MicroCutter Xchange 30 Blue Cartridges because they may fail to fire staples completely, potentially causing incomplete tissue transection or anastomosis during surgery.

    Product
    MicroCutter Xchange 30 Blue Cartridge, FG-025320; The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE 30 Blue Curved Tip Cartridge contain 316L stainless steel staples. The cartridges are used with the MicroCutter XCHANGE 30 Stapler, which is a single patient devic
    Category
    Medical Device
    Distribution
    16 states
  • SevereFDA (Devices)·Z-0483-2016·2015-12-30

    Cardica Recalls MicroCutter Xchange 30 Blue Curved Tip Cartridges

    Cardica, Inc. is recalling MicroCutter Xchange 30 Blue Curved Tip Cartridges because incomplete staple firing may result in incomplete tissue transection or anastomosis during surgery.

    Product
    MicroCutter Xchange 30 Blue Curved Tip Cartridge. Model Number: FG-025321; The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE 30 Blue Curved Tip Cartridge contain 316L stainless steel staples. The cartridges are used with the MicroCutter XCHANGE 30 Stapler, which
    Category
    Medical Device
    Distribution
    16 states
  • SevereNHTSA·15V887000·2015-12-30

    BMW Recalls Two 2016 Models for Steering Gearbox Defect

    BMW is recalling two 2016 vehicles (one MINI Cooper Convertible, one BMW X1) because incorrect steering gearbox parts may cause loss of vehicle control.

    Product
    BMW — BMW, MINI X1, COOPER CONVERTIBLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0440-2016·2015-12-30

    Biomerieux Recalls Etest PIP/TAZO/CON-4 PTC Antimicrobial Susceptibility Tests

    Biomerieux is recalling Etest PIP/TAZO/CON-4 PTC antimicrobial susceptibility tests due to the potential for reporting erroneous results, specifically false susceptible results for Piperacillin/Tazobactam.

    Product
    Etest¿ PIP/TAZO/CON-4 PTC 256 -pack of 30 tests US. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0448-2016·2015-12-30

    Aesculap Flexible Orthopedic Instrument Tray Set Recalled for Breakage Risk

    Aesculap, Inc. is recalling flexible orthopedic instrument tray sets because the shafts may break during surgery, potentially leaving fragments in patients.

    Product
    Tray Set containing multiple instruments and may contain the flexible bone awl, flexible drill and/or flexible screw driver in varying amounts depending on order. Tray set is not sealed. These instruments are intended for use during the implantations of the A-Space SIBD and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0543-2016·2015-12-30

    Philips Recalls Cardinal Health Tiny Toes Infant Heel Warmers

    Philips Electronics North America is recalling Cardinal Health Tiny Toes infant heel warmers because they may cause first and second degree burns.

    Product
    Cardinal Health Tiny Toes; 11470-010T Infant heel warmer
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0285-2016·2015-12-30

    United Trading Center Recalls Golden Raisins for Undeclared Sulfites

    United Trading Center Inc. is recalling 16-ounce packages of Basma golden raisins because they contain undeclared sulfites. The product was distributed in New York and Pennsylvania.

    Product
    Basma 3 Chris Court Dayton, New Jersey 08810 Tel.:7323559600 Fax: 7323559644 16 oz package This golden raisin product is labeled in a foreign language.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0422-2016·2015-12-30

    Aesculap Flexible Screw Driver Recalled Due to Potential Shaft Breakage

    Aesculap, Inc. is recalling 37 Flexible Screw Driver SJ706R units because the flexible shaft may break during surgery, posing a risk of fragments remaining in patients.

    Product
    Flexible Screw Driver SJ706R; Non Sterile; B Braun; Aesculap; Aesculap AG These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0435-2016·2015-12-30

    Salted Smoked Split Herring Recalled for Being Uneviscerated

    P East Trading Corporation is recalling salted smoked split herring in bulk wooden boxes because the product was found to be uneviscerated.

    Product
    Salted Smoked Split Herring in bulk wooden boxes, Net Wt. 18 lbs., Product of Canada --- No label provided for bulk product.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0424-2016·2015-12-30

    Aesculap Flexible Drill Recalled Due to Potential Shaft Breakage During Surgery

    Aesculap, Inc. is recalling 13 Flexible Drill instruments (SJ723R) because the flexible shaft may break during orthopedic spinal surgery, posing a risk of surgical delay or retained fragments.

    Product
    Flexible Drill; SJ723R; NON STERILE; B Braun Aesculap; Aesculap AG These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0475-2016·2015-12-30

    Arthrosurface Total Toe Instrument Kit Recalled for Sterilization Failure

    Arthrosurface is recalling 3 Total Toe Instrument Kits because a hex driver component failed to pass half-cycle sterilization due to a design oversight.

    Product
    Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number: 9000-3002 The component in question is the hex driver (part number 2009-4001).
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0441-2016·2015-12-30

    Biomerieux Recalls Etest PIP/TAZO/CON-4 PTC 256 Antimicrobial Susceptibility Tests

    Biomerieux is recalling Etest PIP/TAZO/CON-4 PTC 256 antimicrobial susceptibility tests due to the potential for reporting false susceptible results for Piperacillin/Tazobactam.

    Product
    Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests WW. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0436-2016·2015-12-30

    Draeger Recalls Optional PS500 Power Supply Units for Ventilators

    Draeger Medical is recalling 2,422 optional PS500 power supply units for Evita V500 and Babylog VN500 ventilators due to unexpectedly short battery run times.

    Product
    Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a ventilation unit intended for the ventilation of neonatal and pediatric patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0456-2016·2015-12-30

    BD Vacutainer K2 EDTA Blood Collection Tubes Recalled for Stopper Defect

    Becton Dickinson is recalling 4.8 million blood collection tubes because stoppers may not be fully inserted, posing a risk of blood exposure.

    Product
    BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. Product Usage: BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0471-2016·2015-12-30

    Biomet Black Mamba Suture Passer Recalled for Weld Defect

    Biomet is recalling 50 Black Mamba Suture Passers because a weld defect may cause the instrument's jaw to fail to actuate properly.

    Product
    Black Mamba Suture Passer
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-0459-2016·2015-12-30

    Siemens Reagent Management System Recalled for Electrical Hazard

    Siemens is recalling four Reagent Management System units because a missing safety cover exposes an electrical termination block, creating a shock hazard.

    Product
    Reagent Management System (RMS) Dimension EXL with LM STM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension¿ clinical chemistry system. The RMS doubles the available storage of refrigerated Flex¿ reagent cartridges on the Dimension¿ s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0470-2016·2015-12-30

    Hardy Diagnostics Recalls FB Broth Due to Potential Contamination

    Hardy Diagnostics is recalling FB Broth (Lot 15231) because of potential Burkholderia fungorum contamination. The product was distributed in California, Wisconsin, Maryland, and Utah.

    Product
    FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria broth for the enriched cultivation of Neisseria spp., Haemophilus spp., Streptococcus spp., Corynebacterium spp., and other fastidious bacteria from clinical specimens.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0463-2016·2015-12-30

    Boston Scientific Recalls IntellaTip MiFi XP Catheters Due to Tip Bends

    Boston Scientific is recalling IntellaTip MiFi XP catheters because the rate of distal tip bends and kinks exceeded anticipated levels during routine monitoring.

    Product
    IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 OUS; Material Number: M004EPM4790N40; Catalog number: EPM4790N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0458-2016·2015-12-30

    Siemens Reagent Management System Recalled for Electrical Hazard

    Siemens is recalling 106 Reagent Management System units because a missing safety cover exposes an electrical hazard on the compressor.

    Product
    Reagent Management System (RMS) Dimension EXL with LM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension¿ clinical chemistry system. The RMS doubles the available storage of refrigerated Flex¿ reagent cartridges on the Dimension¿ syste
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0460-2016·2015-12-30

    Siemens Reagent Management System Recalled for Electrical Hazard

    Siemens is recalling Reagent Management System (RMS) modules for the Dimension RxL Max clinical chemistry system because some units have missing safety covers on electrical termination blocks.

    Product
    Reagent Management System (RMS) Dimension RxL Max w/o HM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension¿ clinical chemistry system. The RMS doubles the available storage of refrigerated Flex¿ reagent cartridges on the Dimension¿ syst
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0551-2016·2015-12-30

    Terumo Recalls Winged Infusion Sets Due to Improper Bonding

    Terumo Medical Corp is recalling 80,500 units of Surflo Winged Infusion Sets distributed in California due to potential improper bonding between the tube and luer.

    Product
    Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0461-2016·2015-12-30

    Siemens Reagent Management System Recalled for Electrical Safety Hazard

    Siemens is recalling 151 Reagent Management System units because missing safety covers expose electrical termination blocks, creating a shock hazard.

    Product
    Reagent Management System (RMS) Dimension RxL Max HM STM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension¿ clinical chemistry system. The RMS doubles the available storage of refrigerated Flex¿ reagent cartridges on the Dimension¿ sy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·16718·2015-12-30

    KTM Recalls 2015-2016 Freeride 250R Motorcycles Due to Fuel Leak Fire Risk

    KTM North America is recalling about 550 model year 2015 and 2016 Freeride 250R off-road motorcycles because fuel can escape from the tank breather assembly, posing a fire and injury risk.

    Product
    KTM Competition/Closed Course Off-Road Motorcycles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0474-2016·2015-12-30

    Becton Dickinson Recalls Enterococcus Screen Agar QUAD Plates

    Becton Dickinson is recalling 770 units of Enterococcus Screen Agar QUAD Plates due to potential breakthrough growth of Enterococcus faecalis near the end of shelf life.

    Product
    Enterococcus Screen Agar QUAD Plate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0419-2016·2015-12-30

    Fat Bastard Gourmet Chick Dip Recalled for Undeclared Honey

    The Family Jewels LLC is recalling Fat Bastard Gourmet Chick Dip because it contains undeclared honey, a major food allergen.

    Product
    Fat Bastard Gourmet Chick Dip Honey Roasted Hickory Smoke Sassy Barbecue, Net Wt. 12 Fl. Oz. (375 ml), UPC 8 91929 12702 8. The responsible firm name on the label is The Family Jewels, Montreal, MO 65591.
    Category
    Food
    Distribution
    4 states
  • HighNHTSA·15V886000·2015-12-30

    Micro Bird Recalls 2015 School Buses for Stop Arm Decal Issue

    Micro Bird is recalling 66 model year 2015 school buses because the stop arm decal may peel off, reducing visibility and increasing crash risk.

    Product
    MICRO BIRD — MICRO BIRD MB II SCHOOL BUS, G5 SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0424-2016·2015-12-30

    Reser's Potato Salad Recalled for Possible Listeria Contamination

    Reser's Fine Foods is recalling Winn Dixie Old Fashioned Potato Salad due to possible Listeria monocytogenes contamination.

    Product
    Winn Dixie Old Fashioned Potato Salad, Net Wt. 16oz (1 LB) 454g.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0392-2016·2015-12-30

    Boston Scientific Recalls Chariot Guiding Sheaths Due to Shaft Separation

    Boston Scientific is voluntarily recalling Chariot Guiding Sheaths after receiving complaints about shaft separation, which could lead to embolism of device fragments.

    Product
    Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene oxide: Product Description Material Number (UPN) Guiding Sheath 5F, 45 cm, ST, CC H74939277545110 Guiding Sheath 5F, 45 cm, MP, CC H74939277545210 Guiding Sheath 6F, 45 cm, ST, CC H74939277645110 G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0445-2016·2015-12-30

    CareFusion Recalls Alaris Pump SmartSite Infusion Sets Due to Leakage Risk

    CareFusion is recalling Alaris Pump SmartSite Infusion Sets because disconnection and leakage may occur during infusion.

    Product
    Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0467-2016·2015-12-30

    Siemens MAGNETOM MRI Systems Recalled for Quench Line Installation Errors

    Siemens is recalling MAGNETOM MRI systems due to potential quench line installation errors that could cause oxygen displacement or cold burns.

    Product
    MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0453-2016·2015-12-30

    Zimmer Universal Power System Handpieces Recalled for Malfunction

    Zimmer, Inc. is recalling 89 Universal Power System handpieces that may start by themselves when the power source is connected.

    Product
    Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Single Trigger Handpiece. Rx only Made in Switzerland
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-0450-2016·2015-12-30

    Biomet Recalls A.L.P.S. 4.0mm Cancellous Locking Screws Due to Thread Defect

    Biomet is recalling A.L.P.S. 4.0mm Cancellous Locking Screws because a single-lead thread design may cause screws to sit proud or back out, potentially requiring revision surgery.

    Product
    A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones.
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-0552-2016·2015-12-30

    Airways Development Recalls WaterPAP Positive Airway Pressure Devices

    Airways Development LLC is recalling 1,464 WaterPAP Positive Airway Pressure Devices due to a reported canister leak.

    Product
    Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0455-2016·2015-12-30

    CareFusion Recalls Alaris EtCO2 Module 8300 Due to Calibration Error

    CareFusion is recalling 157 Alaris EtCO2 Module 8300 units because they may have been tested with high CO2 concentrations, potentially causing incorrect measurements.

    Product
    Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR).
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0423-2016·2015-12-30

    Aesculap Flexible Bone Awl Recalled for Potential Shaft Breakage

    Aesculap, Inc. is recalling 41 Flexible Bone Awls (SJ607R) because the flexible shaft may break during surgery, posing a risk of fragments remaining in patients.

    Product
    Flexible Bone Awl; SJ607R; NON STERILE; B Braun Aesculap; Aesculap AG: These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·16068·2015-12-30

    Origin8 Recalls Folding Bicycles Due to Frame Breakage and Fall Hazard

    Origin8 is recalling F1, F3, and F7 folding bicycles because the frame welds can crack or fail, posing a fall hazard. Consumers should stop using the bikes and return them for a free replacement.

    Product
    Origin8 folding bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0452-2016·2015-12-30

    Zimmer Universal Power System Handpieces Recalled for Malfunction

    Zimmer, Inc. is recalling 87 Universal Power System handpieces because a malfunction could cause them to start unexpectedly when connected to a power source.

    Product
    Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trigger Handpiece. Rx only Made in Switzerland
    Category
    Medical Device
    Distribution
    32 states
  • ModerateFDA (Drugs)·D-0525-2016·2015-12-30

    Perrigo Recalls Equaline All Day Allergy Tablets Due to Impurity

    Perrigo is recalling Equaline All Day Allergy tablets because they contain an impurity called cetirizine monosaccharide ester.

    Product
    EQUALINE ALL DAY ALLERGY — EQUALINE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0469-2016·2015-12-30

    Instratek Recalls Angled Hook Blades for Endoscopic Tarsal Tunnel Decompression

    Instratek is recalling 39 sterile angled hook blades that do not fit into the handle of the Endoscopic Tarsal Tunnel Decompression system.

    Product
    Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0529-2016·2015-12-30

    Ameditech ProScreen 6 Panel Dip Drug Screen Recall for Reduced Reactivity

    Ameditech is recalling ProScreen 6 Panel Dip Drug Screen kits due to reduced reactivity for two specific benzodiazepine compounds.

    Product
    ProScreen 6 Panel Dip Drug Screen, Item No. PSD-6BUPO3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0439-2016·2015-12-30

    Biomerieux Recalls Etest Piperacillin/Tazobactam Tests Due to False Results

    Biomerieux is recalling Etest Piperacillin/Tazobactam tests because they may report false susceptible results for bacteria.

    Product
    Etest¿ Piperacillin/tazobactam (4 ug/mL) PTc0.016-256-pack of 30 tests WW Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0464-2016·2015-12-30

    Boston Scientific Recalls IntellaTip MiFi XP Catheters Due to Tip Bends

    Boston Scientific is recalling IntellaTip MiFi XP catheters because the rate of distal tip bends and kinks exceeded anticipated levels during routine monitoring.

    Product
    IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-8 Material Number: M004PM4500N40; Catalog number: PM4500N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for treat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0542-2016·2015-12-30

    Ameditech Recalls Thermo Fisher 8 Drug Cassettes Due to Reduced Reactivity

    Ameditech is recalling 100 Thermo Fisher 8 Drug Cassettes because they may show reduced reactivity for two specific benzodiazepine compounds.

    Product
    THERMO FISHER 8 DRUG CASSETTE, Item No. MTPA-8MBAU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0550-2016·2015-12-30

    Siemens Syngo Imaging XS PACS Recall for Incorrect Print Sizes

    Siemens is recalling 42 units of Syngo Imaging XS software because printouts may be in incorrect anatomical size when using unsupported printers.

    Product
    Syngo Imaging XS is a Picture Archiving and Communication System (PACS)
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0451-2016·2015-12-30

    Shimadzu Mobile X-ray Systems Recalled for Image Transfer Issues

    Shimadzu Medical Systems is recalling 297 Mobile X-ray systems because images may not transfer properly to the image server.

    Product
    Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and allows a technician to take a general digital radiography of patients in the hospital or medical facility who cannot move and outpatients in emergency.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0512-2016·2015-12-30

    Ameditech ImmuTest Cup 7-panel Drug Test Recall for Reduced Reactivity

    Ameditech is recalling ImmuTest Cup 7-panel drug tests because they may show reduced reactivity for two specific benzodiazepine compounds.

    Product
    ImmuTest Cup 7-panel w/ Adulteration, Item No. IMCA-7P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0549-2016·2015-12-30

    Philips Ingenuity CT System Recall for Perfusion Software Access Issue

    Philips is recalling 31 Ingenuity CT systems because the perfusion scan feature may be unavailable on specific software versions.

    Product
    Ingenuity CT Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0462-2016·2015-12-30

    Boston Scientific Recalls IntellaTip MiFi XP Catheters Due to Tip Bends

    Boston Scientific is recalling IntellaTip MiFi XP catheters because the rate of distal tip bends and kinks exceeded anticipated levels during routine monitoring.

    Product
    IntellaTip MiFi XP Asymmetric (N4) Curve, 7/110/2.5/8-8 OUS; Material Number: M004EPM4500N40; Catalog number: EPM4500N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0477-2016·2015-12-30

    Dental Dressing Recall for Missing Drug Component Percentages

    Rainbow Specialty & Health Products is recalling Dressit-X dental dressings because the labeling does not list the percentage of drug components.

    Product
    Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingredients: Eugenol Oil
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0491-2016·2015-12-30

    Ameditech CLIA RDTC 12-Panel Cup Recall for Reduced Benzodiazepine Reactivity

    Ameditech is recalling 10,320 CLIA RDTC 12-Panel Cup kits nationwide because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.

    Product
    CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12, DCC-81205-5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0479-2016·2015-12-30

    DePuy Mitek Recalls VAPR Tripolar Suction Electrodes Due to Button Color Error

    DePuy Mitek is recalling 127 VAPR Tripolar 90 Degree Suction Electrodes because the ablation and coagulation buttons are colored incorrectly. The wiring is correct, and the issue affects button color only.

    Product
    VAPR¿ TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028)
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0545-2016·2015-12-30

    Philips Brilliance iCT CT System Recalled for Perfusion Software Issue

    Philips is recalling 51 Brilliance iCT CT systems because the perfusion scan feature may be unavailable on specific software versions.

    Product
    Brilliance iCT Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0547-2016·2015-12-30

    Philips Ingenuity Core CT System Recalled for Perfusion Software Access Issue

    Philips Medical Systems is recalling 135 Ingenuity Core CT systems because a software upgrade may have restricted access to the basic axial perfusion feature for some users.

    Product
    Ingenuity Core Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0473-2016·2015-12-30

    Becton Dickinson Recalls Vancomycin Screen Agar Due to Growth Issues

    Becton Dickinson is recalling specific lots of Vancomycin Screen Agar because expired and in-date products may show breakthrough growth of vancomycin-susceptible Enterococcus faecalis near the end of shelf life.

    Product
    Vancomycin Screen Agar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0480-2016·2015-12-30

    Synaptive Medical BrightMatter Navigator System Recalled for RF Emission Exceedance

    Synaptive Medical is recalling eight BrightMatter Navigator Systems because they exceeded radio frequency emission limits. The devices were distributed to facilities in five US states.

    Product
    Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The Guide system is comprised of a cart labelled SYN-0024 and a cart labelled SYN-0025, Operator Cart. A planning and intraoperative guidance system to enable open and percutaneous computer a
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0488-2016·2015-12-30

    Ameditech 12-Panel Dip Drug Screen Recalled for Reduced Benzodiazepine Reactivity

    Ameditech is recalling 12-Panel Dip Drug Screen kits because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.

    Product
    12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP, PSD-6MTDBO300, PSD-10PPX, PSD-10MOX, 60960D, 61127D, DCC-81205-5, IMCA-10M5.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0466-2016·2015-12-30

    Synvasive Oscillating Saw Blades Recalled for Incorrect Cutting Width Labeling

    Synvasive Technology Inc is recalling 14 oscillating saw blades that incorrectly identify the cutting width as 25mm instead of 19mm.

    Product
    Zimmer Oscillating Flat - TS ST Hub; 75mm x 19mm x 1.00/1.27mm; Synvasive Part No. 11-4770: Part No. 19075127YT1; Lot No. 45104 and 43054 Description: STRYK_76542K_19X75X1.27T General and Plastic Surgery: The oscillating surgical saw blade is intended for use with p
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0468-2016·2015-12-30

    Siemens Factor VIII Chromogenic Assay Recalled for Irregular Curves

    Siemens Healthcare Diagnostics is recalling Factor VIII Chromogenic Assay kits due to irregular curves on specific Sysmex systems, which may cause erroneously increased results.

    Product
    Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD. --- CLASSIFICATION NAME: Test, Qualitative and Quantitative Factor Deficiency
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0454-2016·2015-12-30

    DePuy Spine Recalls Aegis Torque Handles Due to Assembly Defect

    DePuy Spine is recalling 16 Aegis Torque Handles because a manufacturing error may prevent them from fully assembling with the tightener shaft.

    Product
    Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0508-2016·2015-12-30

    Ameditech Immutest 11 Pnl Drug Screen Cup Recall for Reduced Reactivity

    Ameditech is recalling Immutest 11 Pnl Drug Screen Cups because they may show reduced reactivity for two specific benzodiazepine compounds.

    Product
    Immutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0498-2016·2015-12-30

    Ameditech DrugSmart Cup Recall for Reduced Benzodiazepine Reactivity

    Ameditech is recalling DrugSmart Cup drug tests because they may show reduced reactivity for two specific benzodiazepine compounds.

    Product
    DrugSmart Cup THC/COC/AMP//MET/OPI2/BZO, Item No. 60600D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0481-2016·2015-12-30

    Siemens Artis Fluoroscopic X-ray Systems Recalled for Display Soldering Defect

    Siemens is recalling 17 Artis fluoroscopic X-ray systems due to improper soldering in display modules that could cause video signal loss.

    Product
    Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0490-2016·2015-12-30

    Ameditech Benzodiazepine Test Kits Recalled for Reduced Reactivity

    Ameditech Inc is recalling 31,472 Benzodiazepine Strip Dip Card kits because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.

    Product
    BZO Strip Dip Card (300ng/ml)*, Item No. 100170
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0548-2016·2015-12-30

    Philips CT System Recall for Missing Perfusion Scan Feature

    Philips is recalling 177 Ingenuity Core 128 CT systems because the perfusion scan feature may be unavailable on specific software versions.

    Product
    Ingenuity Core 128 Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0449-2016·2015-12-30

    Zimmer NexGen Knee Implant Recalled for Missing Inner Package Seal

    Zimmer Manufacturing B.V. is recalling 179 NexGen System tibial components due to missing Tyvek seals on inner packaging, reported from Thailand.

    Product
    Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoat, Stemmed Size 3; Lot Number:62460264. Indicated for patients with severe knee pain and disability and is intended for mating with a UHMWPE articular surfa
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0497-2016·2015-12-30

    Ameditech DrugSmart Cup 10 Recall for Reduced Benzodiazepine Reactivity

    Ameditech is recalling DrugSmart Cup 10 units because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.

    Product
    DrugSmart Cup 10, Item No. 61093D-3C, 61085D, 61015D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0476-2016·2015-12-30

    Dental Dressing Recall Due to Missing Drug Component Percentages

    Rainbow Specialty & Health Products is recalling Dressol-X and Dressit-X dental dressings because the labels do not list the percentage of drug components.

    Product
    Dressol-X, Radiopaque D-502, NDC 11004-502-40, Dental Use Only, Active Ingredients: A.S.A. (Acetylsalicylic Acid) + Eugenol
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0465-2016·2015-12-30

    Boston Scientific Recalls IntellaTip MiFi XP Catheters Due to Tip Bends

    Boston Scientific is recalling IntellaTip MiFi XP catheters because the rate of distal tip bends and kinks exceeded anticipated levels during routine monitoring.

    Product
    IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 ; Material Number: M004PM4790N40; Catalog number: PM4790N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for tr
    Category
    Medical Device
    Distribution
    Distributed nationwide

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