Archive
745 recalls were announced in November 2015.
Of the 745 recalls this month scored against our rubric, 3% are Critical, 56% are Severe.
Which agencies issued them
Alcon Research, Ltd. is recalling five units of Custom Pak 9319-27 ophthalmic surgical devices because they contain latex gloves despite being labeled as latex-free.
GE Medical Systems is recalling MR Surgical Suite II Tables because a defect in the transfer release mechanism may prevent patient transfer between the MR and surgical tables.
Otto Bock is recalling the Triton Smart Ankle and iOS Galileo app due to a software issue that can cause unexpected foot movement, posing a fall risk.
Interactive Motion Technologies is recalling eight robotic hand accessories for the InMotion Arm rehabilitation robot due to a potential pinch hazard if protective covers are removed.
Krispy Kreme is recalling Chocolate Iced Custard Filled Doughnuts because they may contain glass. Consumers should not eat the product.
Baxter Healthcare Corp. is recalling 19,440 units of 15L Cycler Drainage Bags due to leakage from the inlet port. The products were distributed in the US and Canada.
CareFusion is recalling SmartSite Extension Sets because they may disconnect or leak. The recall affects 21,000 units distributed in the US and Canada.
GE Healthcare is recalling Centricity Universal Viewer versions 6.0 and higher because magnified projection X-ray images may display inaccurate distance measurements.
Krispy Kreme is recalling Original Glazed Doughnuts because they may contain foreign matter, specifically glass.
GE Healthcare is recalling Centricity PACS-IW software because it may display inaccurate distance measurements for magnified projection X-ray images.
Exactech is recalling eight Novation Element femoral hip implant stems that did not receive the specified Hydroxyapatite coating.
Krispy Kreme is recalling specific lots of Glazed Lemon Filled Doughnuts because they may contain glass.
Philips is recalling 1,553 HeartStart MRx Monitor/Defibrillators because automated tests may degrade capacitors and the low battery indicator may fail.
Resource Optimization & Innovation LLC is recalling 255 Regard Custom Surgical Packs due to flow restriction issues in the trifurcated IV set.
Valeant Pharmaceuticals is recalling specific bottles of Fenoglide (fenofibrate) 120 mg tablets because they failed 24-month dissolution testing.
Arrow International Inc is recalling 12,157 units of various PICC and midline catheter kits because the peel-away component hub tabs may prematurely detach during use.
Ivoclar A. G. is recalling specific lots of Helioseal F dental sealant because a production defect caused particles to be larger than defined, resulting in difficulties during extrusion.
Pyng Medical is recalling MATResponder and MATCombat tourniquets because some were not returned to the Ready position before packaging.
ELITech Clinical Systems is recalling specific reagents used on Selectra ProS and ProM systems due to potential drug interference. No complaints have been received.
Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems due to a software anomaly where user-modified parameters revert to default values during ADD installation.
Biomet Spine is recalling 17 MaxAn cervical spine screws because 4.5 mm units were mislabeled as 4.0 mm.
ELITech Clinical Systems is recalling Eon 100 reagents due to potential drug interference. No complaints have been received.
Barco Inc. is recalling specific surgical display models because user settings are lost when the systems are powered off and back on.
Dako North America Inc. is recalling specific lots of EnVision FLEX visualization reagent kits due to a buffer defect causing non-specific background staining that interferes with result interpretation.
Stryker Spine is recalling 41 units of the UniVise Spinous Process Fixation Plate System Inserter because the inner shaft does not fit through the device.
ELITech Clinical Systems is recalling Eon 300 reagents due to potential drug interference. No complaints have been received.
ELITech Clinical Systems is recalling Envoy 500 reagent kits due to potential drug interference. No complaints have been received.
Philips is recalling 264 GEMINI PET/CT systems because the CT subsystem's Spindle Block Servo Controllers may fail prematurely.
Bausch + Lomb is recalling Biotrue ONEday contact lenses because a manufacturing defect on the lens surface may cause visual disturbances like halos or poor vision.
Vintage Pharmaceuticals is recalling specific lots of Ranitidine Syrup because preservative levels failed stability specifications.
Steris Corporation is recalling 32 AMSCO 400 and AMSCO C Small Steam Sterilizers because a software defect prevents the foot pedal from operating the door.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 9, Lot 0954, due to an increase in wash error condition codes.
C.R. Bard is recalling 4,170 units of Antibacterial Hydro Personal Catheters because the unit label may incorrectly state the product code and size.
Forest River is recalling 2016 Coachmen Mirada motorhomes because the parking brake may fail to hold the vehicle or disengage properly, increasing crash and fire risks.
Van Hool is recalling 48 model year 2015-2016 TD925 and TDX25 motorcoaches because air brakes may take too long to release, potentially causing brake drag, heat buildup, or fire.
Maserati is recalling 135 model year 2016 GranTurismo vehicles because passenger side door latches may not be heat treated, increasing injury risk in a crash.
Spartan Motors is recalling 2014-2015 MetroStar and Defense Department chassis cabs because improperly tightened axle nuts may cause the driveshaft to disconnect.
Belle Investment Corporation is recalling Richie House boys' jackets due to drawstrings that pose an entanglement and strangulation hazard to children.
Ignite USA LLC is recalling about 130,000 Bueno by Contigo Kids Straw Tumblers because small straw pieces can break off and be swallowed or inhaled by children.
Thor Motor Coach is recalling specific Damon, Four Winds, and Thor motorhomes because a bolt on the electric entry steps may fracture, causing the steps to become unstable and increasing the risk of injury.
FontanaArte is recalling Sonmi pendant lamps because the glass shade can detach and fall, posing injury risks. Consumers should remove the shade and contact the company for repair.
PACCAR is recalling specific Peterbilt auto haulers because front tires have a lower speed rating than the vehicle's maximum speed, increasing crash risk.
BMW is recalling 2014-2015 MINI Cooper and Cooper S vehicles because incorrectly calibrated seat sensors may cause inappropriate airbag activation or deactivation during a crash.
SynTec is recalling S3B Track Mounted Seats because they may tilt rearward in a severe rear-end collision, posing a risk of injury.
Forest River is recalling 2010-2016 Surveyor recreational trailers because the Federal Certification Placard lists incorrect tire and rim sizes, which may lead to poor handling if incorrect tires are installed.
Cloverdale Foods is recalling beef and pork bratwurst mislabeled as beef frankfurters because it contains undeclared milk, a known allergen.
Boulder Natural Meats is recalling approximately 3,607 pounds of beef, pork, and poultry products due to misbranding and undeclared milk allergen.
Maple Leaf Foods is recalling approximately 4,030 pounds of boneless pork shoulders that entered the U.S. without inspection. The products were shipped to retail locations in California.
Outdoors RV is recalling 2015-2016 Timber Ridge, Glacier Peak, Wind River, and Black Stone trailers because liquid propane hoses and electrical wires may be pinched or scraped, increasing the risk of fire.
Fireworks Over America is recalling Space Monkey multi-effect fireworks because the lit firework can tip over and fire shells at bystanders, posing burn, fire, and impact hazards.
Athens Foods is recalling approximately 168 pounds of beef products because they contain undeclared soy, a known allergen. No adverse reactions have been reported.
Nissan is recalling specific 2015 Altima and 2016 Maxima vehicles because front brake caliper mounting bolts may not be properly tightened, which could reduce braking ability.
Collins is recalling 2006-2016 school buses with Ricon wheelchair lifts where pivot holes may allow bearings to move, risking platform failure.
Club Car is recalling about 11,600 Precedent gas golf and transport vehicles because a hose clamp can wear a hole in the fuel tank, posing a fire risk.
T3 Micro is recalling about 8,400 Twirl 360 curling irons because the clamp can detach, posing a burn hazard. Consumers should stop using the product and contact T3 for a free repair.
Dodgen is recalling 2006-2014 Mobility RVs with specific Ricon wheelchair lifts. Pivot holes may allow bearings to move, risking platform failure and injury.
Nova Bus is recalling 2010-2015 LFS and 2013-2015 LFS Artic transit buses because a passenger counter sensor may pinch a passenger's arm in the door.
Fresca Foods is recalling Sea Salt Crunchy Bean Snacks because ranch-flavored product containing undeclared milk was packaged in sea salt bags.
MCF Operating LLC is recalling Hellmann's Zesty Italian Dressing because it was manufactured with romano cheese that tested positive for Listeria monocytogenes.
JD & SN Inc. is recalling 5 syringes of Testosterone Propionate Injectable Solution due to a lack of assurance of sterility.
JD & SN Inc. is recalling Estradiol 18 mg pellets because the company cannot assure the sterility of the product. The recall covers all sterile human compounded drugs within their expiry date.
The FDA is recalling 9 vials of Chorionic Gonadotropin Injectable Solution from Moses Lake Professional Pharmacy due to a lack of assurance of sterility.
The FDA is recalling Estradiol pellets from JD & SN Inc. because the manufacturer cannot ensure the sterile compounded drugs are free of contamination.
Park Compounding Pharmacy is recalling specific vials of Caffeine + Sodium Benzoate 500mg/mL due to a lack of assurance of sterility.
JD & SN Inc. is recalling 6 syringes of Dexpantenol Injectable Solution because the FDA identified a lack of assurance of sterility.
JD & SN Inc. is recalling TRIMIX injectable solution because the agency could not ensure the product remained sterile. Patients should stop using the medication and contact their healthcare provider.
JD & SN Inc. is recalling 95 vials of Chorionic Gonadotropin because the FDA could not verify the sterility of the compounded drug.
Moses Lake Professional Pharmacy is recalling Estradiol Pellets because the FDA determined there is a lack of assurance of sterility for the compounded drug.
JD & SN Inc. is recalling 298 units of compounded testosterone pellets because the FDA cannot ensure the product is sterile.
The FDA is recalling 36 syringes of Methylcobalamin Injectable Solution because the manufacturer cannot ensure the product is sterile.
JD & SN Inc. is recalling a compounded injectable solution because the FDA could not ensure the product remained sterile. Patients should stop using the medication and contact their healthcare provider.
Park Compounding Pharmacy is recalling specific vials of Methylcobalamin 1000mcg/mL due to a lack of assurance of sterility.
Moses Lake Professional Pharmacy is recalling 355 testosterone pellets because the FDA cannot assure they are sterile. Patients should stop using the product and consult a healthcare provider.
JD & SN Inc. is recalling 8 syringes of Vitamin D3 Oil Injectable Solution due to a lack of assurance of sterility.
FDA is recalling a compounded injectable solution due to a lack of assurance of sterility. The product is distributed nationwide.
The FDA is recalling Estradiol pellets compounded by Moses Lake Professional Pharmacy because the firm cannot assure the sterility of the product.
Moses Lake Professional Pharmacy is recalling 30 syringes of compounded injectable cyanocobalamin because the product lacks assurance of sterility.
JD & SN Inc. is recalling 15 syringes of Trimix injectable solution because the FDA could not assure the sterility of the compounded drug.
JD & SN Inc. is recalling Hydroxocobalamin Injectable Solution because the agency cannot ensure the product is sterile. Patients should stop using the product and contact their healthcare provider.
Siemens Medical Solutions is recalling 158 radiation therapy machines due to a potential safety risk of the gantry colliding with patients or treatment tables.
The FDA is recalling 6 syringes of Pyridoxine HCL injectable solution from JD & SN Inc. due to a lack of assurance of sterility.
Moses Lake Professional Pharmacy is recalling compounded chorionic gonadotropin injectable solutions because the FDA cannot assure the sterility of the product.
Sincerely Nuts is recalling raw macadamia nuts found to be contaminated with Salmonella. The affected products were sold nationwide via online sales.
The FDA is recalling specific lots of compounded testosterone pellets from Moses Lake Professional Pharmacy because the manufacturer cannot ensure the products are sterile.
JD & SN Inc. is recalling 42 syringes of Chorionic Gonadotropin/Cyanocobalamin Injectable Solution due to a lack of assurance of sterility.
JD & SN Inc., dba Moses Lake Professional Pharmacy, is recalling Methylcobalamin Injectable Solution because the agency cannot assure the sterility of the compounded drug.
FDA is recalling specific lots of compounded testosterone pellets because they lack assurance of sterility. Patients should contact their healthcare provider.
JD & SN Inc. is recalling 116 mg testosterone pellets because the agency could not ensure the sterile compounded drugs were sterile.
FDA is recalling 64 syringes of compounded chorionic gonadotropin from Moses Lake Professional Pharmacy due to lack of assurance of sterility.
JD & SN Inc., dba Moses Lake Professional Pharmacy, is recalling 30 mL vials of an injectable solution containing vitamins, lidocaine, and other compounds due to a lack of assurance of sterility.
JD & SN Inc. is recalling 5 syringes of Hydroxocobalamine/Methylcobalamine Injectable Solution due to a lack of assurance of sterility.
JD & SN Inc. is recalling specific vials of Chorionic Gonadotropin injectable solution because the agency could not ensure the sterile human compounded drugs were sterile.
JD & SN Inc. is recalling specific syringes of Methylcobalamin Injectable Solution because the FDA cannot assure the sterility of the compounded drug.
JD & SN Inc. is recalling 184 syringes of compounded chorionic gonadotropin nationwide because the FDA could not ensure the product was sterile.
FDA is recalling Alprostadil Injectable Solution vials from Moses Lake Professional Pharmacy because the agency cannot assure the sterility of the compounded drug.
JD & SN Inc. is recalling EDETATE CALCIUM DISODIUM Injectable Solution due to a lack of assurance of sterility.
JD & SN Inc. is recalling 50 mg testosterone pellets because the FDA cannot ensure the sterile compounded drugs are free from contamination.
Moses Lake Professional Pharmacy is recalling 11 syringes of Medroxyprogesterone Acetate because the FDA determined there is a lack of assurance of sterility.
JD & SN Inc. is recalling 4 syringes of Vitamin D3 Oil Injectable Solution due to a lack of assurance of sterility.
Moses Lake Professional Pharmacy is recalling Estradiol 20 mg pellets because the FDA determined there is a lack of assurance of sterility.
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