The Recall Desk

Archive

September 2017 recalls

342 recalls were announced in September 2017.

What the numbers show

Critical
24
Severe
115
High
101
Moderate
92
Low
10

Of the 342 recalls this month scored against our rubric, 7% are Critical, 34% are Severe.

Which agencies issued them

301–342 of 342

  • HighFDA (Devices)·Z-3096-2017·2017-09-06

    Siemens AXIOM Artis zee and Q/Q.zen X-ray Systems Recalled for Cooling Leak

    Siemens is recalling 986 AXIOM Artis zee and Q/Q.zen angiography systems in the US due to a cooling system leak that can cause equipment failure.

    Product
    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3074-2017·2017-09-06

    Kentec Medical Recalls Pediatric Nasogastric Feeding Tubes Due to Radiopaque Stripe Issue

    Kentec Medical Inc is recalling specific lots of Polyurethane ENFit Ameritus NG Feeding Tubes because the radiopaque stripes may be inadequately detectable.

    Product
    POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, WITH SIDE PORT, REF Numbers: a) ENF-Y50P-40 b) ENF-Y50P-50 c) ENF-Y60P-40 d) ENF-Y60P-50 e) ENF-Y60P-90 f) ENF-Y80P-40 g) ENF-Y80P-50 h) ENF-Y80P-80 i) ENF-Y80P-90 For pediatric and Neonatal Use, ENFit ENTERAL USE ONLY,
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-3093-2017·2017-09-06

    Siemens AXIOM Artis zee and Q/Q.zen X-ray Systems Recalled for Cooling Leak

    Siemens is recalling 986 AXIOM Artis zee and Q/Q.zen angiography systems in the US due to a cooling system leak that could cause equipment failure.

    Product
    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3088-2017·2017-09-06

    Siemens AXIOM Artis zee and Q/Q.zen X-ray Systems Recalled for Cooling Leak

    Siemens is recalling 986 AXIOM Artis zee and Q/Q.zen angiography systems due to a cooling system leak that could cause equipment failure.

    Product
    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3095-2017·2017-09-06

    Siemens Medical Solutions Recalls AXIOM Artis zee and Q Angiography Systems

    Siemens Medical Solutions is recalling 986 AXIOM Artis zee and Q angiography systems in the US due to a cooling system leak that could cause equipment failure.

    Product
    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3099-2017·2017-09-06

    Siemens AXIOM Artis zee and Q/Q.zen X-ray Systems Recalled for Cooling Leak

    Siemens is recalling 986 AXIOM Artis zee and Q/Q.zen angiography systems in the US due to a cooling system leak that could cause equipment failure.

    Product
    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3090-2017·2017-09-06

    Siemens AXIOM Artis zee and Q/Q.zen X-ray Systems Recalled for Cooling Leak

    Siemens is recalling 986 AXIOM Artis zee and Q/Q.zen angiography systems in the US due to a cooling system leak that could cause equipment failure.

    Product
    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3089-2017·2017-09-06

    Siemens AXIOM Artis zee and Q/Q.zen X-ray Systems Recalled for Cooling Leak

    Siemens is recalling 986 AXIOM Artis zee and Q/Q.zen angiography systems in the US because a cooling system leak could cause equipment failure.

    Product
    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·17218·2017-09-06

    Kawasaki Recalls Brute Force 300 ATVs Due to Fuel Leak Fire Hazard

    Kawasaki is recalling about 20,000 Brute Force 300 ATVs because the fuel tap or carburetor can leak fuel, posing a fire hazard. No injuries have been reported.

    Product
    Brute Force 300 all-terrain vehicles (ATVs)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3071-2017·2017-09-06

    Smiths Medical CADD Medication Cassette Reservoir Recall for Manufacturing Defects

    Smiths Medical ASD Inc. is recalling CADD Medication Cassette Reservoirs due to potential incorrect pressure plates and tubing routing.

    Product
    CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented stopper included, REF 21-7002-24, Rx only, STERILE EO, Manufacturer Smiths Medical ASD, Inc.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3073-2017·2017-09-06

    Kentec Medical Recalls Pediatric Nasogastric Feeding Tubes Due to Radiopaque Stripe Defect

    Kentec Medical Inc is recalling specific lots of polyurethane ENFit nasogastric feeding tubes for pediatric and neonatal use because the radiopaque stripes are inadequately detectable.

    Product
    POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, REF Numbers: a) ENF-50P-40 b) ENF-50P-50 c) ENF-50P-80 d) ENF-60P-40 e) ENF-60P-50 f) ENF-60P-80 g) ENF-80P-40 h) ENF-80P-50 i) ENF-80P-80 j) ENF-100P-110 For pediatric and Neonatal Use, ENFit ENTERAL USE ONLY, RADIOPAQ
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-3079-2017·2017-09-06

    Recall of MEDLINE SIRUS Surgical Gowns Due to Inconsistent Sleeve Sealing

    Master & Frank (Pinghu) Co., Ltd. is recalling 2,160 units of MEDLINE SIRUS Surgical Gowns because inconsistent sleeve seam sealing may allow fluid to pass through.

    Product
    MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile Single-Use Gown; Sold in kit with Sterile Gown/Hand Towel/CSR Wrap and boxes of 18 Gowns.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-3081-2017·2017-09-06

    Alcon Recalls LuxOR Ophthalmic Microscope Floor Stands Due to Caster Defect

    Alcon is recalling 1,074 LuxOR microscope floor stands because casters may break or detach from the base after impact or stress.

    Product
    LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmic Microscope. LX3 Microscope Floor Stands are not stand-alone medical devices, but are used in combination with the LuxOR Ophthalmic Microscope and the LuxOR Ophthalmic Microscope with Q-VUE 3-D Assista
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3098-2017·2017-09-06

    Siemens AXIOM Artis zee and Q/Q.zen X-ray Systems Recalled for Cooling Leak

    Siemens is recalling 986 AXIOM Artis zee and Q/Q.zen angiography systems in the US due to a cooling system leak that can cause equipment failure.

    Product
    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1125-2017·2017-09-06

    Morton Grove Recalls Amoxicillin and Clavulanate Potassium Oral Suspension

    Morton Grove Pharmaceuticals is recalling 7,332 bottles of Amoxicillin and Clavulanate Potassium Oral Suspension due to a customer complaint of a blue nitrile glove fragment found in the product.

    Product
    Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg per 5 mL, 100 mL (when reconstituted) bottle, Rx Only, Manufactured By: Cipla Ltd. at Medispray Laboratories Pvt. Ltd., Kundaim Goa, India; Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054, NDC
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3036-2017·2017-09-06

    NeuroLogica Recalls Samsung GU60A Digital X-ray Systems for Radiation Exposure

    NeuroLogica Corporation is recalling 87 Samsung GU60A digital X-ray systems because unintended areas are exposed to radiation during the Stitching function.

    Product
    Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3100-2017·2017-09-06

    Smith & Nephew Recalls Polarstem Cardan Joints Due to Fracture Risk

    Smith & Nephew is recalling 402 Polarstem Cardan joints because the device may fracture or fail after multiple uses.

    Product
    smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON STERILE, QTY: (1), Rx only The subject cardan is used in conjunction with a curved stem impactor used to implant the POLARSTEM hip stem. The hip stem is mounted on the s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3384-2017·2017-09-06

    Newark Nut Stores Recalls Bourbon Street Mix for Undeclared Cashews

    Newark Nut Stores is recalling Bourbon Street Mix because it contains undeclared cashews, a common allergen. The recall follows a customer complaint.

    Product
    Bourbon Street Mix, 157 25 lbs cases and 2,509 one (1) lb bags.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0010-2018·2017-09-06

    Optovue iVue 500 Recalled for Missing 510(k) for Vault Mapping Software

    Optovue is recalling 326 iVue 500 devices because FDA determined a 510(k) is needed for the Vault Mapping software.

    Product
    iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0009-2018·2017-09-06

    Optovue iFusion and iVue Recalled for Missing 510(k) Approval

    Optovue is recalling 326 iFusion and iVue devices because FDA determined a 510(k) is needed for the Vault Mapping software.

    Product
    iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3468-2017·2017-09-06

    KIND Breakfast Dark Chocolate Cocoa Bars Recalled for Mislabeling

    KIND, LLC is recalling 4-count boxes of KIND Breakfast Dark Chocolate Cocoa Bars because the outer boxes may be mislabeled and contain KIND Breakfast PROTEIN Dark Chocolate Cocoa Bars.

    Product
    4-count boxes of KIND Breakfast Dark Chocolate Cocoa Bars 1.76 oz (50g) Outer Box: UPC: 60265220102-8
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3044-2017·2017-09-06

    Neusoft Medical NeuViz 64 CT Scanner Software Defect Recall

    Neusoft Medical Systems is recalling 234 NeuViz 64 CT scanners due to a software defect. The FDA mandated this recall for units distributed nationwide.

    Product
    Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version Product Usage: The Multi-Slice CT Sca
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3076-2017·2017-09-06

    BioMérieux Recalls VITEK 2 Compact 30 Software and Reagent Cards

    BioMérieux is recalling VITEK 2 Compact 30 software and reagent cards because a software update prevents test cards from finalizing results, potentially disrupting laboratory processing.

    Product
    VITEK¿ 2 Compact 30, REF numbers: 27530 and 27530R (clinical), and 27630 and 17630R (industry) software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1124-2017·2017-09-06

    Amphastar Recalls Ketorolac Injection Due to Crystallization

    Amphastar Pharmaceuticals is recalling Ketorolac Tromethamine Injection because crystallization was observed in retained samples.

    Product
    Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials, Rx only, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, CA 91730, NDC 0548-9021-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3083-2017·2017-09-06

    Med Tec Recalls CIVCO Rigid Arm Supports for Height Discrepancy

    Med Tec Inc is recalling CIVCO Rigid Arm Supports used in Posiboard-2 and Posirest assemblies due to a potential 17mm height difference.

    Product
    CIVCO Arm Support, REF 106047, distributed as: (a) Rigid Arm Support, Large, Set, Red (PN: 106047) (b) PB2-BDLRL (PN: 109040) (c) Rigid Adj. Arm Support, Large, Set (PN: 106048) (d) PSR2-CF-DLRL-2P Posirest-2 (PN: 106522) The Rigid Arm Supports are utilized on the Posibboa
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-3102-2017·2017-09-06

    Encore Medical Recalls Turon Glenoid Reamers Due to Dimensional Error

    Encore Medical is recalling five Turon Glenoid Reamers because the spherical radius cutting surface was manufactured with the wrong dimension, resulting in a larger surface than intended.

    Product
    MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: REF S-200956 - 5mm PIN, SIZE 46 REF S-200957 - 5mm PIN, SIZE 50 REF S-200958 - 5mm PIN, SIZE 58
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-3075-2017·2017-09-06

    BioMérieux Recalls VITEK 2 Compact 15 Software and Reagent Cards

    BioMérieux is recalling VITEK 2 Compact 15 software and reagent cards because they may fail to finalize test results after a software update.

    Product
    VITEK¿ 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3078-2017·2017-09-06

    Certified Safety Mfg Recalls Sterile Burn Sheets for Shredding Risk

    Certified Safety Mfg Inc is recalling sterile burn sheets included in first aid kits because they may shred, potentially failing to protect patients from infection.

    Product
    Burn Sheet, sterile - 60" x 96". Included in First Aid Kits: 36M - Delmarva Power/ACE - w/Logo, Certified Safety Manufacturing logo, and sold blank. product Usage: Provides sterile environment to protect patient from infection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3101-2017·2017-09-06

    Beckman Coulter UniCel DxH Slidemaker Stainer Recall for Fitting Seal Defect

    Beckman Coulter is recalling 310 UniCel DxH Slidemaker Stainer units because a fitting may not completely seal after installation.

    Product
    UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH Slidem
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1126-2017·2017-09-06

    Tris Pharma Recalls Morphine Sulfate Oral Solution Due to Leaking

    Tris Pharma is recalling 34,824 bottles of Morphine Sulfate Oral Solution because the liquid is leaking from the containers.

    Product
    MORPHINE SULFATE — MORPHINE SULFATE (MORPHINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3092-2017·2017-09-06

    Siemens AXIOM Artis zee and Q/Q.zen X-ray Systems Recalled for Cooling Leak

    Siemens is recalling 986 AXIOM Artis zee and Q/Q.zen angiography systems in the US because a cooling system leak could cause equipment failure.

    Product
    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0008-2018·2017-09-06

    Optovue iVue Recall for Missing 510(k) on Vault Mapping Software

    Optovue is recalling 326 iVue devices because FDA determined a 510(k) is needed for the Vault Mapping software.

    Product
    iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three dimensional imaging and measurement of anterior an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3097-2017·2017-09-06

    Siemens AXIOM Artis zee and Q/Q.zen X-ray Systems Recalled for Cooling Leak

    Siemens is recalling 986 AXIOM Artis zee and Q/Q.zen angiography systems in the US due to a cooling system leak that can cause equipment failure.

    Product
    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3094-2017·2017-09-06

    Siemens AXIOM Artis zee and Q/Q.zen x-ray systems recalled for cooling leak

    Siemens is recalling 986 AXIOM Artis zee and Q/Q.zen x-ray systems in the US because a cooling system leak could cause equipment failure.

    Product
    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3077-2017·2017-09-06

    Edwards Lifesciences Recalls Fogarty Adherent Clot Catheters Due to Balloon Size Error

    Edwards Lifesciences is recalling specific Fogarty Adherent Clot Catheters because the balloon diameter measures 6mm instead of the intended 10mm.

    Product
    Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The Fogarty adherent clot catheters are designed to effectively remove clot material in the peripheral vasculature. The catheters are indicated for the removal of emboli and thrombi from native art
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3084-2017·2017-09-06

    Alere iScreen Dx Urine Drug Screen Card Recalled for Labeling Error

    Ameditech Inc is recalling Alere iScreen Dx Urine Drug Screen Cards because the kit box label incorrectly identifies PCP instead of TCA as a drug analyte.

    Product
    Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 IFU insert. The Alere iScreen Dx Drug Screen Card is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes mon
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-3484-2107·2017-09-06

    Mary's Gone Crackers Recalled for Blue Plastic Liner Fragments

    Mary's Gone Crackers is recalling Original Crackers because pieces of blue grade plastic liner were found inside the packaged product.

    Product
    Mary's Gone Crackers Original Crackers: Organic, Gluten Free, Non-GMO, Vegan. 6.5 oz. (184 g) box; Ingredients: Whole grain brown rice, whole grain quinoa, brown flax seeds, brown sesame seeds, filtered water, sea salt, wheat free tamari (water, whole soybeans, salt, vinegar
    Category
    Food
    Distribution
    10 states
  • HighCPSC·17765·2017-09-05

    ASHERANGEL Recalls Children's Sleepwear for Flammability Violations

    ASHERANGEL is recalling about 950 children's nightgowns and pajama sets sold on Amazon.com because they fail federal flammability standards, posing a burn risk.

    Product
    Children's nightgowns and pajama sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·17V551000·2017-09-01

    2018 Prime Time Tracer Recalled for Incorrect Tire Pressure Placard

    Forest River is recalling 2018 Prime Time Tracer trailers because the Federal Placard may list incorrect tire pressure information, posing a crash risk.

    Product
    PRIME TIME — PRIME TIME TRACER
    Category
    Vehicle
    Distribution
    Distributed nationwide

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