Archive
588 recalls were announced in November 2013.
Of the 588 recalls this month scored against our rubric, 2% are Critical, 18% are Severe.
Which agencies issued them
Hyundai is recalling 21,207 2007-2008 Entourage vehicles because front lower control arms may fracture due to corrosion, increasing the risk of a crash.
Fallon Wellness Pharmacy is recalling 241 prefilled Bevacizumab syringes because third-party testing suggests sterility test results may have been inaccurate.
Chrysler is recalling 2008-2012 RAM 4500 and 5500 trucks because the left tie rod assembly may break, potentially causing loss of steering control.
Synthes USA HQ, Inc. is recalling 319 units of the Sternal Zip Flex System because the application instrument may cut the implant, leading to loosening.
Western Nut Company is recalling specific lots of roasted and salted inshell peanuts because they contain unacceptable levels of aflatoxin.
Pentax Medical is recalling 76 OF-B194 Gas/Water Feeding Valves due to a manufacturing defect that may cause improper CO2 gas stoppage during endoscopic procedures.
Chrysler is recalling specific 2008-2012 Dodge RAM trucks because the left tie rod assembly may break, potentially causing loss of steering control and increasing crash risk.
Chrysler is recalling 2013 Dodge Avenger, Chrysler 200, and 2014 Jeep Compass and Patriot vehicles due to abrasive debris in engine bearings that may cause oil pressure loss and engine failure.
Edwards Lifesciences is recalling EMBOL-X Glide Protection Systems because the cannula tip may deform. The recall covers 12,034 units distributed in the US and Canada.
Chrysler is recalling specific Dodge Ram trucks because the left tie rod assembly may break, potentially causing a loss of steering control and increasing crash risk.
Xoran Technologies is recalling 320 Mini CT Scanners because they failed to meet internal specifications for dose rate, with complaints indicating rates both high and low.
Chrysler is recalling 2013 Dodge Dart vehicles because front seat side airbags may not be properly installed, potentially failing to deploy in a crash.
Siemens is recalling RAPIDPoint and RAPIDLab blood gas analyzers because users may enter wrong patient IDs, leading to sample misidentification.
Kellogg Canada is recalling Pringles Salt and Vinegar Potato Chips because the packaging failed to declare milk as an ingredient, violating Canadian labeling regulations.
GE Healthcare is recalling Centricity PACS-IW software due to issues that could display incorrect patient images or under-report dose values, posing a safety risk to patients.
Siemens is recalling RAPIDLab 1200 Series blood gas analyzers because users may enter the wrong patient ID, leading to sample misidentification.
Stryker is recalling 67 TPS Micro Drivers because silicone potting failed to cure properly, which could cause material leakage or electrical malfunction.
Siemens Healthcare Diagnostics Inc. is recalling RAPIDPoint 400 series blood gas analyzers because users may enter incorrect patient IDs, leading to sample misidentification.
Siemens is recalling RAPIDLab and RAPIDPoint blood gas analyzers because users can enter wrong patient IDs, risking sample misidentification.
Baxter Healthcare is recalling 49,344 units of Vented Spike Adapters because potential tears in the pouch could compromise sterility.
Price Chopper Supermarkets is recalling 10-inch apple pies because they contain undeclared eggs. The recall affects pies sold in New York, Connecticut, and Vermont.
Xoran Technologies is recalling Minicat CT Scanners that failed to meet specifications for dose rate, potentially affecting patient safety.
Toshiba is recalling 427 Aplio MX Diagnostic Ultrasound Systems because the transducer head may overheat during specific imaging modes.
Carestream Health is recalling 180 DRX-Revolution Mobile X-ray Systems because the power plug generates sparks and becomes warm to the touch.
Globus Medical is recalling MicroFuse Putty because the sterility assurance level cannot be verified. The product is a bone graft extender used in medical procedures.
Toshiba is recalling 477 Xario XG Diagnostic Ultrasound Systems because the transducer head may overheat during specific imaging modes.
Toshiba is recalling 17 diagnostic ultrasound systems because the transducer head may overheat under specific operating modes, posing a burn risk to patients.
Medtronic is recalling Activa PC and RC deep brain stimulators due to a potential for overstimulation or stimulation in the wrong area during device recovery.
Fujinon Inc is recalling 12 ultrasonic endoscopes due to missing set screws that secure the biopsy inlet port.
Siemens is recalling RAPIDPoint 405 blood gas analyzers because users may enter incorrect patient IDs, leading to sample misidentification.
Barrel O' Fun Snack Foods Co. is recalling Snack Artist BBQ Flavored Potato Chips because they contain undeclared milk.
Intuitive Surgical is recalling 1,090 da Vinci Si Surgical Systems because improper restraints during transport could cause the monitor to become loose from its mount.
Siemens is recalling RAPIDLab 1265 blood gas analyzers because users may enter wrong patient IDs, leading to sample misidentification.
Medtronic is recalling RestoreUltra and RestoreSensor neurostimulators because they may deliver over-stimulation or stimulation to the wrong area under specific conditions.
Toshiba is recalling 430 diagnostic ultrasound systems because the transducer head may overheat under specific operating conditions.
DePuy Spine is recalling 102 units of Pipeline LS Dilators and Holding Clips because they were used for neuromonitoring, a function for which the devices are not FDA cleared.
Xoran Technologies is recalling 320 MiniCAT CT Scanners because the gantry may fail to rotate while emitting radiation.
bioMerieux, Inc. is recalling 90 units of chromID Salmonella Agar because Salmonella strains may grow as white colonies instead of the expected pink to mauve color, potentially leading to missed detections.
S.A.E. Afikim is recalling 69 Breeze C electric scooters because an electrical contact may fail, potentially preventing the driver from stopping the vehicle.
Philips is recalling 13 Ingenuity TF PET/CT systems due to software issues that could require patients to be re-injected with PET radiopharmaceuticals during rescans.
American Importing Co, Inc. is recalling Amport Foods Chocolate Raisins because a package of Milk Chocolate Peanuts was erroneously labeled as Milk Chocolate Raisins.
Siemens is recalling RAPIDLab 1245 blood gas analyzers because users may enter wrong patient IDs, potentially leading to sample misidentification.
Zimmer, Inc. is recalling NexGen CR-Flex Mobile Bearing Tibial Components because the packaging bags adhere to the device surfaces.
Medtronic Vascular is recalling Valiant and Talent Thoracic Stent Grafts with Captivia Delivery Systems because the graft cover is difficult to flush during preparation.
Cordis is recalling 29,395 Optease Vena Cava Filters because a printing error on one unit caused it to be implanted upside down, requiring an additional procedure.
Integra Limited is recalling specific Camino Intracranial Pressure Monitoring Catheters and Kits because they lack required labeling indicating they are unsafe in MRI environments.
Zimmer, Inc. is recalling NexGen Femoral Components because the packaging bags adhere to the device surfaces. The recall covers 11,694 units distributed worldwide.
Philips is recalling 371 BrightView XCT gamma cameras because the Flat Panel Detector may not remain securely latched in the stowed position.
HemoCue AB is recalling HemoCue Hb 201 Microcuvettes due to a production-related issue causing punctured single-pack pouches.
Zimmer, Inc. is recalling NexGen femoral components because the packaging bags adhere to the device surfaces.
Zimmer, Inc. is recalling Sidus Heads because the packaging bags adhere to the device surfaces. No units were distributed in the United States.
Zimmer, Inc. is recalling Natural-Knee Flex Femoral Components because the low-density polyethylene packaging bags adhere to the polished device surfaces.
Zimmer, Inc. is recalling Multipolar Bipolar Cup Metal Shell implants because the packaging bag adheres to the device surface.
DePuy Spine is recalling 105 Pipeline LS Access System dilators and holding clips because they were used for neuromonitoring, a function for which the devices are not cleared.
Xoran Technologies is recalling 320 Minicat CT Scanners because they failed to meet specifications for dose rate. The devices were distributed worldwide and in the US.
Sysmex America Inc is recalling 193 pocH-100i Automated Hematology Analyzers because the thermal printer may omit digits or decimal points in printed results.
HemoCue AB is recalling Urine Albumin Microcuvettes due to a production issue causing punctured single-pack pouches.
Xoran Technologies is recalling 320 MiniCAT CT Scanners because they failed to meet specifications for dose rate.
DePuy Spine is recalling 100 units of Pipeline LS Dilators because they were used for neuromonitoring, a function for which the device is not FDA cleared.
Small Bone Innovations is recalling 2,036 radial and ulnar stem implants due to a risk of sterile packaging breach.
Zimmer, Inc. is recalling Metasul Head implants because the low-density polyethylene packaging bags adhere to the device surfaces.
Zimmer, Inc. is recalling CPT Femoral Stems because the low-density polyethylene packaging bags adhere to the polished device surfaces.
Zimmer, Inc. is recalling Natural-Knee II Femoral Components because the low-density polyethylene packaging bags adhere to the polished device surfaces.
Zimmer, Inc. is recalling knee implant components because the packaging bags adhere to the device surfaces.
Xoran Technologies is recalling 320 MiniCAT CT Scanners because they failed to meet specifications for dose rate. The devices may operate at dose rates higher or lower than required.
DePuy Spine is recalling 118 Pipeline LS Dilators and Holding Clips because they were used for neuromonitoring, a function for which the devices are not FDA cleared.
Intuitive Surgical is recalling specific da Vinci Single Site instruments because they were shipped without the correct user manual revision, which contains necessary instructions, warnings, and precautions.
Maquet Medical Systems USA is recalling 63 CARDIOHELP Base Units because they may display error messages and have touch screens that turn black.
Intuitive Surgical is recalling da Vinci Single Site Bipolar Maryland Forceps and curved needle drivers shipped with incorrect user manuals.
Beckman Coulter is recalling LH 750 and LH 780 hematology analyzers because check valves may fail, causing air or liquid leaks.
Zimmer, Inc. is recalling 5,103 Gender Solutions Patello-Femoral Components because the packaging bags adhere to the device surfaces.
Zimmer, Inc. is recalling CoCr heads used in total hip replacements because the packaging bags adhere to the device surfaces.
Carestream Health is recalling 23 DRX Revolution Mobile X-Ray Systems because a software update without detector calibration can cause image artifacts.
Baxter Healthcare is voluntarily recalling 3,200 units of CLEARLINK Extension Sets due to potential pinholes in the packaging that could breach the sterile barrier.
Atossa Genetics is recalling ForeCYTE Breast Health Test kits due to FDA concerns regarding instructions for use and promotional claims.
DePuy Spine is recalling 198 Pipeline LS Holding Clips because they were used for neuromonitoring, a function for which the device is not FDA cleared.
GE Healthcare is recalling 623 Centricity PACS Workstations due to software workflow interruptions that may prevent exams from closing correctly in the system.
Zimmer, Inc. is recalling Versys Beaded Fullcoat Femoral Stems because the packaging bag adheres to the polished device surface.
One World Technologies is recalling Ryobi P113 battery chargers because they can overheat, posing fire and burn risks to consumers.
Kia is recalling 2006-2012 Sedona vehicles in specific states because front lower control arms may break due to corrosion, increasing crash risk.
Infinity Green is recalling about 2,000 Candelabra LED Bulbs because they can overheat and catch fire. Consumers should stop using them and contact the company for a refund.
Cooper Crouse-Hinds is recalling specific ceiling boxes that can crack and cause light fixtures to fall, posing an impact hazard.
Elite is recalling 2006-2013 cargo trailers with Fastec door locks that may jam, potentially trapping occupants inside.
SK Innovation is recalling Econix DPF-A diesel particulate filters manufactured in August 2009 because missing maintenance instructions may cause the filter to melt, potentially leading to a fire.
Carlisle Transportation Products is recalling specific Black Rock CrossTrax trailer wheels because the lips may crack and separate, potentially causing rapid tire air loss and increasing crash risk.
BMW is recalling 2,608 motorcycles because rear wheel drive bearings and axles may wear due to incorrect tolerances, potentially affecting handling and increasing crash risk.
Honda is recalling 2007-2008 Odyssey vehicles because the Vehicle Safety Assist System may apply brakes unexpectedly, increasing the risk of a rear-end crash.
Mercedes-Benz is recalling 130 model year 2013 SL63, SL550, and SL65 vehicles because the occupant classification system may fail to detect very light passengers, potentially disabling the side air bag.
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