Archive
533 recalls were announced in June 2013.
Of the 533 recalls this month scored against our rubric, 5% are Critical, 33% are Severe.
Which agencies issued them
Nora Apothecary is recalling Chlorhexidine Ophthalmic Solution 0.02% because FDA inspections raised concerns about quality control and sterility assurance.
Hong Lee Trading Inc. is recalling 30 cases of preserved apricots nationwide due to undeclared sulfites and Yellow #5 dye.
Nora Apothecary and Alternative Therapies, Inc. is recalling Methylcobalamin Injections due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Nora Apothecary is recalling Super Trimix #1 Penile Injection because FDA inspections raised concerns about quality control and sterility assurance.
Nora Apothecary and Alternative Therapies, Inc. is recalling 7 units of Dexamethasone Opth Soln 0.1% PF due to lack of assurance of sterility identified during an FDA inspection.
Nora Apothecary and Alternative Therapies, Inc. is recalling Methylcobalamin Injections due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Nora Apothecary is recalling Folic Acid Inj 5mg/ml due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Nora Apothecary and Alternative Therapies, Inc. is recalling Hydroxyprogesterone Inj 250mg/ml MDV, 5 ml Intramuscular due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Nora Apothecary is recalling Bimix Inj 30:1 syringes because FDA inspections raised concerns about quality control and sterility assurance.
Toyota is recalling 87,060 model year 2010 Prius and Lexus HS250h vehicles because nitrogen gas from the brake booster pump assembly could leak into the brake fluid, potentially reducing hydraulic pressure and increasing the risk of a crash.
Stoneridge Inc. is recalling specific ignition switches that may cause the starter to engage before the key is turned, risking injury or crashes.
Nora Apothecary and Alternative Therapies, Inc. is recalling Methylcobalamin Injections due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Nora Apothecary and Alternative Therapies, Inc. is recalling HCG Inj 500un/ml MDV, 5 ml Subcutaneous due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Nora Apothecary and Alternative Therapies, Inc. is recalling PGE-1 penile injections nationwide due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Nora Apothecary and Alternative Therapies, Inc. is recalling PGE-1 Penile Injections because FDA inspections raised concerns about quality control and sterility assurance.
Nora Apothecary is recalling Hydroxycobalamin Injections because FDA inspections raised concerns about quality control and sterility assurance.
Nora Apothecary is recalling Meperidine 100mg/ml MDV, 5ml vials due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Nora Apothecary is recalling Glutathione 200mg/ml injections nationwide due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Nora Apothecary is recalling PGE-1 Penile Injections because FDA inspections raised concerns about quality control and assurance of sterility.
Nora Apothecary and Alternative Therapies, Inc. is recalling Hydroxycobalamin Injection 2500 mcg/ml due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Nora Apothecary is recalling Gentamicin 24mg/60ml Irrigation because FDA inspections raised concerns about quality control and sterility assurance.
Nora Apothecary and Alternative Therapies, Inc. is recalling M.I.C.+B12 Inj MDV products due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Nora Apothecary is recalling Tobramycin Ophthalmic Solution because FDA inspections raised concerns about quality control and sterility assurance.
Nora Apothecary is recalling Trimix penile injections because FDA inspections raised concerns about quality control and sterility assurance.
Nora Apothecary is recalling Vancomycin Ophthalmic Solution because FDA inspections raised concerns about quality control and sterility assurance.
Nora Apothecary and Alternative Therapies, Inc. is recalling Methylcobalamin 5mg/ml Injection Syringes due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Nora Apothecary and Alternative Therapies, Inc. is recalling Renacidin Irrigation bladder irrigation products due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Nora Apothecary is recalling Hydroxycobalamin Injections because FDA inspections raised concerns about quality control and sterility assurance.
Nora Apothecary is recalling Trimix penile injections because FDA inspections raised concerns about quality control and sterility assurance.
Nora Apothecary is recalling HCG Inj 1250 un/ml MDV injections because FDA inspections raised concerns about quality control and sterility assurance.
Nora Apothecary and Alternative Therapies, Inc. is recalling Bimix Inj 30:0.5 MDV Penile Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Nora Apothecary is recalling Vancomycin Ophthalmic Solution due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Nora Apothecary is recalling Vancomycin Ophthalmic Solution because FDA inspections raised concerns about quality control and sterility assurance.
Nora Apothecary and Alternative Therapies, Inc. is recalling Papaverine Injections due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Nora Apothecary is recalling Bimix Inj 30:1 MDV penile injections because FDA inspections raised concerns about quality control and sterility assurance.
Nora Apothecary and Alternative Therapies, Inc. is recalling Pyridoxine 100mg/ml Injections due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Nora Apothecary and Alternative Therapies, Inc. is recalling Tobramycin Ophthalmic Solution due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Nora Apothecary is recalling Lidocaine 2% Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.
7-Eleven Stores of Oklahoma is recalling 1,873 Oatmeal Raisin Cookies due to undeclared egg, soy, and milk.
Tropical Valley Foods is recalling next by Nature brand Dark Chocolate Bananas because the product contains undeclared walnuts and milk.
AngioDynamics is recalling Micro Introducer Kits because the packaged sheath or dilator may be the incorrect French size.
Ideations DiveAlert is recalling specific scuba signaling devices that may malfunction and restrict air flow, posing a drowning risk to divers.
Zimmer, Inc. is recalling 69 units of NEXGEN Complete Knee Solution Tibial Drills because the outside diameter may be oversized, preventing them from passing through the drill guide.
Heart Sync, Inc. is recalling Vermed Radiotransparent Defibrillation Electrodes because a supplier defect may prevent the device from delivering appropriate electrical shocks to patients.
Stryker Orthobiologics is recalling 414 Aliquot Plungers because the catheter may break during removal from the needle. The issue is attributed to user error, and the correction involves revised instructions.
Canon Inc. is recalling 384 RK-F2 Ref-Keratometers because the device may display abnormal refractive power values in approximately 5% of cases.
Nora Apothecary and Alternative Therapies, Inc. recalled HCG injection products because FDA inspection findings raised concerns about quality control and sterility assurance. The products were distributed nationwide.
Nephron Pharmaceuticals is recalling EZ Breathe Medication Cups because a component may dislodge, creating a potential choking hazard.
Nephron Pharmaceuticals is recalling AsthmaNefrin Starter Kits because a component may dislodge and cause a choking hazard.
Polymer Technology Systems is recalling PTS Glucose Test Strips because internal testing showed under-recovery of glucose, which could lead to inaccurate readings.
Nora Apothecary is recalling 72 units of Trimix Penile Injection nationwide due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Stryker Orthobiologics is recalling 12 units of the Aliquot Beveled Needle due to reported catheter breakage during vertebroplasty procedures.
Intuitive Surgical is recalling 8mm Precise Bipolar Forceps used with the da Vinci Surgical System because a component may dislodge, preventing proper cautery connection and causing loss of function.
Beckman Coulter is recalling AU2700 and AU5400 Clinical Chemistry Analyzers because tubing connections may leak concentrated detergent.
AngioDynamics is recalling VenaCure EVLT NeverTouch Procedure Kits because the packaged micro Introducer may be the wrong French size.
Nature's Candy, Inc. is recalling 25 lb bulk boxes of Maple Macadamia Nuts in California and Colorado due to potential Salmonella contamination.
Talenti Gelato is recalling 16 fl oz Roman Raspberry Sorbetto containers in Indiana due to undeclared pecans.
Nora Apothecary is recalling Trimix penile injections because FDA inspections raised concerns about quality control and sterility assurance.
Nora Apothecary is recalling Trimix penile injections because FDA inspections raised concerns about quality control and the assurance of sterility.
Nora Apothecary is recalling PHMB Ophthalmic Solution 0.02% because FDA inspections raised concerns about quality control and sterility assurance.
Fisher & Paykel Healthcare is recalling 1,407 ICON CPAP units because they may become inoperable, interrupting treatment for obstructive sleep apnea.
Intuitive Surgical is recalling 8mm Maryland Bipolar Forceps used with the da Vinci Surgical System because the cautery plug insert may dislodge, preventing proper cable connection and causing loss of cautery function.
RaySearch Laboratories AB is recalling RayStation Therapy Treatment Planning System software versions 2.0, 2.5, and 3.0 because imported medical images may be offset by one pixel, potentially leading to incorrect dose calculations.
Elekta, Inc. is recalling Integrity 3.0 multileaf collimators because incorrect static tolerances may prevent the detection of unexpected movement during radiation beam delivery.
Alphatec Spine is recalling the Leucadia Autolok Polyaxial Pedicle Screw System because a tolerancing issue may prevent the rod from locking rigidly, potentially compromising spinal stability.
Heart Sync, Inc. is recalling C100-Physio defibrillation electrodes due to a supplier issue that may prevent the device from delivering appropriate electrical shocks.
Nephron Pharmaceuticals is recalling EZ Breathe Atomizers because a component may dislodge, creating a choking hazard.
Stryker Orthobiologics is recalling 17 units of the Aliquot Plunger, 8", due to reported catheter breakage during vertebroplasty procedures.
Intuitive Surgical is recalling 8mm Fenestrated Bipolar Forceps used with the da Vinci Surgical System because the cautery plug insert may dislodge, preventing proper cable connection and causing loss of cautery function.
TZ Medical Inc. is recalling P-211-M1 and P-214-M1 defibrillation electrodes because they may contain a defective white wire on the connector assembly.
Stryker Orthobiologics is recalling 69 Aliquot Catheters due to reported breakage during vertebroplasty procedures attributed to use errors.
Nora Apothecary and Alternative Therapies, Inc. is recalling Methylcobalamin Injections due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Physicians Total Care is recalling specific lots of Camila 0.35 mg tablets because testing detected an impurity called N-Butyl-Benzene Sulfonamide.
Becton Dickinson is recalling 610 BBL DrySlide PYR Kits because they were placed in incorrect packaging for distribution to laboratories.
Alpine Biomed Aps is recalling Natus neurology Dantec KEYPOINT.NET version 2.20 software due to a software bug. The recall affects 871 installed licenses distributed worldwide.
Beckman Coulter is recalling Lactate Reagent Lot M206209 because it may fail to report numerical values for high lactate concentrations.
Intel-GE Care Innovations LLC is recalling QuietCare monitoring systems because customers reported receiving duplicate alerts. The recall affects 1,722 units distributed in the US and Great Britain.
Orthopedic Alliance LLC is recalling 50 units of loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician for every surgery.
Spinal Solutions is recalling 24 units of 45 mm screws because directions for use and surgical techniques were not provided to every physician.
National Food & Beverage, Inc. is recalling Red Bone Alley Wasabi Sauce due to undeclared metabisulfite. The product was distributed in Florida, Georgia, and South Carolina.
Intel-GE Care Innovations is recalling 46 QuietCare-Networked devices due to duplicate alerts. The devices are used to monitor senior housing residents.
Alere San Diego, Inc. is recalling 3,975 hCG Combo Cassette kits because some were packaged with the wrong product insert.
Spinal Solutions is recalling Copperhead IBFD loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician.
Spinal Solutions is recalling 72 units of 60 mm Rods because directions for use and surgical techniques were not provided to every physician.
Stryker Orthobiologics is recalling 19 units of the Aliquot Diamond Needle due to reported catheter breakage during vertebroplasty procedures.
Orthopedic Alliance LLC is recalling 37 Bipolar Caps because directions for use and surgical techniques were not provided to every physician for every surgery.
Intuitive Surgical is recalling 1,374 user manual addenda for the da Vinci Surgical System to remove an indication and amend warnings for Transoral Surgery.
Stryker Orthobiologics is recalling 35 units of the Aliquot Beveled Needle because the catheter may break during removal. The issue is attributed to user error, and the correction involves updating the Directions for Use.
Orthopedic Alliance LLC is recalling 57 units of loaner bins and sterilization trays because surgical instructions were not provided to every physician.
Intuitive Surgical is recalling 50,000 boxes of Tip Cover Accessories for the da Vinci Surgical System to clarify existing labeling and related cautions.
Spinal Solutions is recalling 52 units of 50 mm screws because directions for use and surgical techniques were not provided to every physician.
Teva Pharmaceuticals is recalling Camrese oral contraceptives because an impurity called N-Butyl-Benzene Sulfonamide was detected during testing.
Intuitive Surgical is recalling 8mm cannulas to clarify existing labeling information and operating procedures.
Mylan Pharmaceuticals is recalling 3,048 bottles of Ropinirole hydrochloride tablets because 3 mg bottles were incorrectly labeled as 4 mg.
Becton Dickinson is recalling BBL DrySlide Oxidase Kits because they were placed in incorrect packaging for distribution to laboratories.
Spinal Solutions is recalling 106 Set Screws (Item #BG3010) because directions for use and surgical techniques were not provided to every physician.
Orthopedic Alliance LLC is recalling loaner bins and sterilization trays for orthopedic implants and instruments because directions for use and surgical techniques were not provided to every physician for every surgery.
The Anspach Effort, Inc. is recalling 1,827 3mm Diamond Ball burrs because three batches may have diamond grit larger than intended.
Intuitive Surgical is recalling da Vinci instrument flush ports to clarify existing labeling and operating procedures.
Orthopedic Alliance LLC is recalling 26 loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician for every surgery.
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