Archive
896 recalls were announced in June 2016.
Of the 896 recalls this month scored against our rubric, 6% are Critical, 24% are Severe.
Which agencies issued them
Well Care Compounding Pharmacy is recalling Estradiol Valerate 10mg/mL vials because FDA inspections found GMP violations that may affect sterility.
Mercedes-Benz is recalling certain 2016 SLK and SL models because low-beam headlights may be aimed incorrectly, potentially reducing driver visibility.
Philips Healthcare is recalling Brilliance iCT SP CT systems due to software defects that cause incorrect scan lengths and dose calculations.
Philips Healthcare is recalling 423 Brilliance 64 CT systems in the US due to software defects causing incorrect scan lengths and dose calculations.
Well Care Compounding Pharmacy is recalling Vitamin B Complex # 1 vials because FDA inspections found GMP violations that may affect sterility.
The Coca-Cola Company is recalling Honest Kids Super Fruit Punch because the label fails to list apple juice, a common allergen, as an ingredient.
Mercedes-Benz is recalling 2016 C300 4Matic vehicles because a software error may cause the electric power steering assist system to shut down, increasing crash risk.
Well Care Compounding Pharmacy is recalling M.l.C. 25mg/50mg/25mg/mL vials because FDA inspections found GMP violations that may affect sterility.
Well Care Compounding Pharmacy is recalling TRI-MIX # 2 vials because FDA inspections found violations that may affect sterility.
Well Care Compounding Pharmacy is recalling Vancomycin 50mg/mL ophthalmic solution due to FDA inspection findings of GMP violations that may impact sterility.
Dough Masters is recalling 7-Eleven Fresh To Go Sugar Cookies with M&M Chocolate Candy because they may contain undeclared peanuts.
Sedecal USA is recalling 145 mobile x-ray systems in the US due to a software defect that may apply adult exposure parameters to newborns.
Well Care Compounding Pharmacy is recalling Methylcobalamin 5mg/mL vials because FDA inspections found GMP violations that may affect sterility.
Werner Gourmet Meat Snacks is recalling Sweet Hot Crunch Mix because the label declares butter but fails to declare milk, a major allergen.
Ortho-Clinical Diagnostics is recalling VITROS 5600 systems due to a software defect that may cause sample aspiration errors, leading to inaccurate or contaminated test results.
Bakery Express is recalling 7-Eleven Fresh To Go Peanut Butter Cookies sold in Florida due to an undeclared peanut allergen.
Becton Dickinson is recalling 811,200 units of 10 mL syringes due to possible adulteration and non-conforming manufacturing practices.
Well Care Compounding Pharmacy is recalling M.I.C. /MB12/B6/DEXPLAN/L-CARN injection vials because FDA inspections found GMP violations that may affect sterility.
Well Care Compounding Pharmacy is recalling Testosterone Cypionate 200mg/mL vials because FDA inspections found GMP violations that may affect sterility.
Well Care Compounding Pharmacy is recalling M.l.C./B5/B6 injection vials due to FDA inspection findings of GMP violations that may impact sterility.
Medtronic is recalling RestoreSensor implantable neurostimulators because insufficient coupling during recharging can cause rapid battery depletion and loss of therapy.
Zimmer Biomet is recalling specific Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets due to incidents of radiolucent lines and loosening in implants.
GE Healthcare is recalling Revolution CT Patient Tables because the cradle can descend on its own, posing a crushing risk to large patients.
Bakery Express is recalling 7-Eleven Fresh To Go Sugar Cookies made with M&M Chocolate Candy because they contain an undeclared peanut allergen.
Hospira is recalling 2,567 Plum A+ infusion pumps because a calibration error caused false occlusion alarms. The devices were distributed in the U.S. and 13 foreign countries.
Nissan is recalling specific 2016 Leaf and Sentra vehicles because a wiring harness connector may disconnect, preventing the passenger air bag from deploying in a crash.
Baxter Healthcare is voluntarily recalling Actifuse ABX and MIS System bone void fillers because they may contain endotoxin levels above specification criteria.
Pulmuone Foods is recalling Noodles with Fire-roasted Black Bean Sauce because the product contains undeclared milk.
Materialise USA LLC is recalling a patient-specific knee surgical guide set because the femur guide does not match the patient, preventing proper use during surgery.
Well Care Compounding Pharmacy is recalling 869 vials of Glutathione 100mg/mL due to FDA-identified GMP violations that may compromise sterility.
Synthes (USA) Products LLC is recalling 244 DePuy Synthes 8.0 mm Flexible Shaft Reamers because they failed biological safety evaluations for cytotoxicity.
Well Care Compounding Pharmacy is recalling Methyl B12 vials because FDA inspections found violations that may affect sterility.
Well Care Compounding Pharmacy is recalling Itraconazole/Mupirocin/Triamcinolone nasal spray because FDA inspections found GMP violations that may affect sterility.
Well Care Compounding Pharmacy is recalling Testosterone Cypionate 10mg/mL vials because FDA inspections found GMP violations that may affect sterility.
Lee Seed Company is recalling Yogurt Super Soynuts because the product contains undeclared milk, posing a risk to individuals with milk allergies.
Philips Healthcare is recalling Brilliance iCT Computed Tomography X-Ray Systems due to software defects that cause incorrect scan lengths and dose calculations.
Novo Nordisk is recalling 723 Norditropin FlexPro pens due to a potential assembly fault that may cause the pen to block during the air shot step.
Philips Healthcare is recalling Ingenuity Core CT systems due to software defects that cause incorrect scan lengths and dose calculations.
Brainlab AG is recalling 27 ExacTrac Vero 3.5 systems due to potentially incorrect positioning when using Implanted Marker Detection.
Sony is recalling Panasonic lithium-ion battery packs for VAIO laptops because they can overheat, posing burn and fire hazards. No injuries have been reported.
Well Care Compounding Pharmacy is recalling Testosterone Cypionate 100mg/mL vials because FDA inspections found GMP violations that may affect sterility.
Pulmuone Foods is recalling Korean Noodles in a Savory Black Bean Sauce because the product contains undeclared milk.
Nuvi Global Corporation is recalling StemVitae Multivitamin bottles due to undeclared whey protein containing milk and soy lecithin.
Frozen Inc. is recalling 24 oz German Chocolate Dessert Bar Cakes because the product does not list pecans on the label.
Hospira is recalling 1,490 Plum 360 infusion pumps because a calibration error may cause false proximal occlusion alarms.
Pulmuone Foods is recalling specific lots of noodles with Beijing Style Black Bean Sauce because they contain undeclared milk.
Karlsburger Foods is recalling 2 lb containers of Mesquite Seasoning Mix because they contain undeclared soy, a major food allergen.
Beckman Coulter is recalling Cholesterol OSR6x16 reagent because Dipyrone may cause erroneous, false low results in cholesterol assays.
Integrated Science Systems is recalling Sure Vue Staph kits due to customer complaints of weak reactions and false negative results.
Synthes (USA) Products LLC is recalling Norian Drillable Inject 10 CC-Sterile units because the internal rotary pouch may be labeled with the incorrect powder volume, though the actual contents are correct.
Synthes (USA) Products LLC is recalling 19 units of 1.5 mm Rapid Resorbable Orbital Floor Plates due to potential expiration date discrepancies on outer packaging labels.
Bayer Health Care LLC is recalling 37,512 bottles of Coppertone Sunscreen Lotion, Clearly Sheer, Broad Spectrum SPF 50, because the product contains undeclared Oxybenzone.
Pharmedium Services is recalling 240 bags of Potassium Chloride Injection due to a labeling error where Potassium Phosphate was printed on the label stock.
Synthes (USA) Products LLC is recalling 22 units of 1.5 mm Rapid Resorbable Orbital Floor Plates because outer package expiration dates may exceed subcomponent dates.
Philips Healthcare is recalling five DuraDiagnost stationary X-ray systems because the detector may incorrectly signal readiness, causing failed image acquisitions.
Aidarex Pharmaceuticals is recalling 292 bottles of Chlorhexidine Gluconate 0.12% Oral Rinse because the product failed impurity specifications.
Datascope is recalling Mega and Sensation Plus Intra-Aortic Balloon Catheter kits because they were packaged with the wrong instruction manual for the STATLOCK device.
Well Care Compounding Pharmacy is recalling 869 units of Hydrogen Peroxide 3% due to FDA inspection findings regarding sterility assurance.
Teleflex Medical is recalling 6,390 sterile tracheal tubes because some units labeled as 7mm may actually be 7.5mm.
Philips Healthcare is recalling 160 DigitalDiagnost stationary X-ray systems because the detector may incorrectly signal readiness, resulting in failed image acquisition.
Beckman Coulter is recalling Lipase OSR6x30 reagent because Dipyrone may cause erroneous false low results in lipase assays.
Ellipse A/S is recalling 14 Ellipse ND: YAG Laser applicators because they lack required instructions for calibration procedures and schedules.
Well Care Compounding Pharmacy is recalling 1-HCG 2000 IU/ML vials due to GMP violations that may affect sterility.
Beckman Coulter is recalling Triglyceride OSR6x118 assays because Dipyrone may cause false low results.
Well Care Compounding Pharmacy is recalling 869 vials of Methylcobalamin 12.5mg/mL due to FDA inspection findings of GMP violations that may impact sterility.
Greiner Bio-One is recalling 4 ml FX Sodium Fluoride/Potassium Oxalate tubes because they may contain low or no additives, potentially affecting glucose and lactate test results.
Beckman Coulter is recalling Uric Acid reagent (OSR6x98) because Dipyrone may cause erroneous, false low results in assays.
Philips Healthcare is recalling Ingenuity Elite CT systems due to software defects that cause incorrect scan lengths and dose calculations.
Stryker is recalling 189 Maestro Air Motor pneumatic cranial drill units because grease buildup may cause the orange grease to leak and contaminate surgical wounds.
Well Care Compounding Pharmacy is recalling Atropine Sulfate 0.5% Ophthalmic Drops due to FDA inspection findings of GMP violations that may impact sterility.
Well Care Compounding Pharmacy is recalling TRI-MIX # 6 vials because FDA inspections found violations that may affect product sterility.
Ellipse A/S is recalling 25 Ellipse ND: YAG Laser applicators because they lack required instructions for calibration procedures and schedules.
Stryker is recalling 21 FlowPort II Adapters because the arthroscope sits in the adapter 180 degrees in the wrong direction.
Well Care Compounding Pharmacy is recalling Phenylephrine 0.5% vials because FDA inspections found violations that may affect sterility.
Beckman Coulter is recalling Lactate OSR6x93 reagent because Dipyrone may cause erroneous false low results.
DePuy Synthes is voluntarily recalling Norian Drillable Inject 5 CC-Sterile units because the internal rotary pouch may be labeled with the incorrect powder volume, though the actual contents are correct.
Synthes (USA) Products LLC is recalling 14 units of 1.5 mm Rapid Resorbable Orbital Floor Plates because outer package expiration dates may exceed subcomponent dates.
Alcon is voluntarily removing specific lots of CENTURION FMS packs due to a molding irregularity that may reduce vacuum in the aspiration line.
DePuy Synthes is voluntarily recalling Norian Drillable Inject 3 CC-Sterile because the internal pouch may be labeled with the incorrect powder volume, though the actual contents are correct.
Remel Inc is recalling Oxoid Nitrocefin reagents because individual bottles may produce weak reactions, leading to delayed or false negative beta-lactamase test results.
Philips Healthcare is recalling Ingenuity CT systems due to software defects that cause incorrect scan lengths and dose calculations.
Medical Components, Inc dba MedComp is recalling specific lots of Tearaway Introducers because they are labeled with incorrect expiration dates.
Aidarex Pharmaceuticals is recalling Ceftriaxone for Injection due to out-of-specification intermediates during manufacturing.
G & M Co. is recalling approximately 3,586 pounds of beef products that may be contaminated with E. coli O157:H7. The products were shipped to retail locations in New Jersey and New York.
PJ Trailers is recalling 2015-2016 T1 single axle tilt trailers because a notch in the steel tongue may compromise its strength, increasing crash risk.
Micro Bird is recalling 79 model year 2015-2016 transit buses because water accumulation in window frames can cause glass to shatter in freezing conditions.
STIHL is recalling about 8,000 HSA 65 battery-powered hedge trimmers because they may operate unexpectedly, posing a laceration hazard.
Terex is recalling 2016 HR, HRX, LT, LTM, TL, TC, and TCX aerial devices because a hydraulic motor shaft may fail, causing unexpected boom rotation or winch movement.
KZRV is recalling 2016-2017 Spree travel trailers because incorrectly installed refrigerator vents may cause overheating and increase the risk of fire.
Grand Rapids Chair is recalling Sadie chairs and barstools because loose parts can create pinch points, posing a risk of finger injury.
Direct Distributors is recalling 4-inch air angle grinders because a safety switch failure can cause the tool to turn on unexpectedly, posing a laceration risk.
Triumph is recalling aftermarket adjustable brake levers for specific 2016-2017 motorcycles because they may contact the handlebar, preventing maximum braking force.
Vermeer is recalling 2014-2016 TG5000 trailers because incorrect pushrod lengths may cause parking brakes to engage unintentionally, increasing crash risk.
Spartan is recalling 2017 Gladiator and K3 motorhome chassis due to a potential electrical short in the engine control module that could cause the engine to stall.
Asian Jade Customs Brokerage is recalling approximately 762 pounds of imported dried pork sausage that was not inspected at the U.S. point of entry.
Nissan is recalling 2014-2016 Infiniti Q50 and Q50 Hybrid vehicles because a steering system error may alter responsiveness and increase crash risk.
Wilson Manifolds is recalling specific Peter Paul 22X01031GM 12/DC solenoid valves due to improper welding that may cause the piston to eject under pressure.
East Manufacturing is recalling 2016 Hybrid and Steel Dump trailers with overstated weight ratings that could lead to overloading and crashes.
Gulf Stream is recalling 2016-2017 Ameri-Lite and Super-Lite trailers because the Federal Certification label lists incorrect tire and wheel sizes, which could lead to installing the wrong replacement parts.
McNeilus is recalling 19 model year 2016 Bridgemaster V Concrete Mixers because bridge axle tube sleeves may crack, potentially causing the axle to detach and increasing crash risk.
Looking for a different month? Back to 2016.