Archive
1,113 recalls were announced in May 2018.
Of the 1,113 recalls this month scored against our rubric, 4% are Critical, 22% are Severe.
Which agencies issued them
Zimmer Biomet is recalling 54 Gentle Threads Interference Screws because overexposure to ethylene oxide sterilization may compromise the sterile barrier, increasing infection risk.
Straumann Manufacturing is recalling Emdogain multipacks because a raw material shelf life change was made without submitting data to demonstrate continued product efficacy.
TP Orthodontics is recalling 7 Jasper Vektor Class II Correction Appliances because they may break in the patient's mouth, posing a risk of injury.
Kroger Specialty Pharmacy is recalling Avonex 30 mcg/0.5 mL PFS Kits due to a lack of processing controls. The affected units were dispensed in five states between December 2017 and February 2018.
Vyaire Medical is recalling 20 AirLife Resuscitation Broselow Hinkle Kits because the mask component may stick, making it difficult to disconnect from the device.
Datascope Corporation is recalling four custom tubing kits because a seal defect may allow air to enter the housing, potentially collapsing the balloon and reducing blood flow.
Vyaire Medical is recalling 42 AirLife Pediatric Resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.
Boston Scientific is recalling 1,002 Uphold Vaginal Support Systems because the Capio sutures may break or detach.
Straumann Manufacturing is recalling Emdogain multipacks because a raw material shelf-life change was implemented without submitting data to demonstrate continued product efficacy.
Vyaire Medical is recalling 17,172 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Vygon U.S.A. is recalling the Maximum Barrier Tray (Product Code MCITX-1) because potential friction holes may affect the product's sterility.
Vyaire Medical is recalling 30 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Siemens Healthcare Diagnostics is recalling the Syva Emit 2000 Tacrolimus Assay because it may produce inaccurate results when patients take sulfasalazine or sulfapyridine.
Vyaire Medical is recalling 180 AirLife Infant Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
TP Orthodontics is recalling 119 Jasper Vektor Class II Correction Appliances because the devices have broken in patients' mouths, posing a risk of injury.
Vyaire Medical is recalling 2,982 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Greenbelt Greenhouse Ltd is recalling 546 packages of Pea Shoots Microgreens due to potential Listeria monocytogenes contamination. The product was distributed in Oregon and Washington.
Vygon U.S.A. is recalling 16,520 PICC Insertion Trays because potential friction holes may affect the sterility of the product.
Vyaire Medical is recalling 5,400 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Vyaire Medical is recalling AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
DePuy Orthopaedics is recalling two ATTUNE Revision CRS Femoral LT knee implants because burrs may be present on the extraction hole threads.
TP Orthodontics is recalling Jasper Vektor Class II Correction Appliances because they may break in the patient's mouth, posing a risk of injury.
Vyaire Medical is recalling 24 pediatric AirLife resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Vyaire Medical is recalling 1,260 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.
Vyaire Medical is recalling 1,800 pediatric AirLife resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Siemens Healthcare Diagnostics is recalling Dimension Sirolimus reagent cartridges because biotin can interfere with test results, potentially affecting patient care.
Vyaire Medical is recalling 180 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Vyaire Medical is recalling 900 AirLife Infant Resuscitation Devices because the mask may stick to the elbow, making it difficult to disconnect.
Kroger Specialty Pharmacy is recalling Revlimid 20 mg oral capsules because of a lack of processing controls. The recall affects specific lots distributed in MS, LA, AR, IL, and FL.
Vyaire Medical is recalling 18 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Vyaire Medical is recalling 6 AirLife Infant Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Boston Scientific is recalling Uphold LITE w/ Capio SLIM devices due to a potential for the Capio sutures to break or detach.
Vyaire Medical is recalling 150 AirLife Resuscitation replacement kits because the mask component may stick to the elbow, preventing disconnection.
Vyaire Medical is recalling 305,136 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.
Draeger Medical is recalling eight Fabius MRI anesthesia machines because automatic or manual ventilation may fail if the motor position is disturbed or the ventilator cover is damaged.
Vyaire Medical is recalling 3,600 AirLife Infant Resuscitators because the mask may stick to the elbow, making it difficult to disconnect.
Siemens Healthcare Diagnostics is recalling the Syva Emit 2000 Sirolimus Assay because it may produce inaccurate results when measuring patients taking sulfasalazine or sulfapyridine.
Bard Peripheral Vascular Inc is recalling 1551 units of the POWERPORT ClearVUE Slim catheter because the included Patient ID Card has incorrect port flushing instructions.
Vyaire Medical is recalling 198 AirLife Infant Resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.
Vyaire Medical is recalling 1,140 pediatric AirLife resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Bard Brachytherapy is recalling Iodine-125 radioactive seeds because incorrect dosage levels were mixed up and sent to two hospitals in California and Georgia.
Vyaire Medical is recalling 24 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Vyaire Medical is recalling 24 AirLife Pediatric Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Play and Park Structures is recalling about 150 SuperMax Triple Slides because a gap between the rails near the entrance poses an entrapment hazard to young children. No injuries have been reported.
Vyaire Medical is recalling 270 pediatric AirLife resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.
Vyaire Medical is recalling 2,262 AirLife Infant Resuscitation Devices because the mask may stick to the elbow, making it difficult to disconnect.
Siemens Healthcare Diagnostics is recalling one lot of Dimension Lipase Flex Reagent Cartridges due to calibration failure causing positive bias in test results.
Vyaire Medical is recalling 8,124 AirLife Infant Resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.
Vyaire Medical is recalling 797 AirLife Resuscitation Broselow Hinkle Kits because the mask may stick to the elbow, preventing disconnection.
Vyaire Medical is recalling 720 pediatric AirLife resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Kroger Specialty Pharmacy is recalling Copaxone 40 mg injections due to a lack of processing controls. The affected products were dispensed in five states between December 2017 and February 2018.
Vyaire Medical is recalling 180 AirLife Infant Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Boston Scientific is recalling 1,258 Capio CL sutures because they may break or detach during transvaginal procedures.
Greenbelt Greenhouse Ltd is recalling Fresh Microgreen Mix due to potential Listeria monocytogenes contamination. The product was distributed in Oregon and Washington.
Vyaire Medical is recalling 498 pediatric AirLife resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Blount Fine Foods is recalling approximately 720 pounds of Chicken Tortilla Soup because the product contains undeclared wheat and may be mislabeled.
Straumann Manufacturing is recalling specific lots of Emdogain because a raw material shelf life change was made without data proving the product remains effective.
Vygon U.S.A. is recalling 16,520 Neonatal PICC Trays because potential friction holes may affect the product's sterility.
Bard Peripheral Vascular Inc is recalling specific lots of POWERPORT ClearVUE catheters because the included Patient ID Card has incorrect port flushing instructions.
Badger Botanicals LLC is recalling specific Kratom products due to potential Salmonella contamination. The recall covers products manufactured between January 1, 2018, and April 12, 2018.
Siemens Healthcare Diagnostics is recalling certain IMMULITE assays because the instructions for use do not list the biotin concentration that causes interference, posing a risk of inaccurate test results.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Cyclosporine because the instructions for use incorrectly state the biotin non-interference level.
Kroger Specialty Pharmacy is recalling one lot of Pulmozyme inhalation solution because it lacks processing controls, which may affect product quality.
Sugarfina LLC is recalling Platinum Bling Rings because an internal audit found undeclared fish gelatin. The product was distributed in 16 states.
Stonewall Kitchen is recalling Basil Pesto Aioli because the product may contain undeclared eggs. The recall affects 732 units distributed in 20 states.
Siemens Healthcare Diagnostics is recalling ADVIA Salicylate reagent chemistry assays because various blood, urine, or cerebrospinal fluid assays may interfere with sulfasalazine and sulfapyridine, causing falsely elevated or depressed salicylate results.
TP Orthodontics is recalling Jasper Vektor Class II Correction Appliances because the devices may break in the patient's mouth, posing a risk of injury.
Boston Scientific is recalling 4,144 units of Capio Standard Box 4 sutures because they may break or detach during surgery.
Volkswagen is recalling 2011-2017 models including Tiguan, Golf, and CC because internal modifications may prevent them from meeting regulatory requirements, increasing crash risk.
NatureBox is recalling specific lots of Whole Wheat Chocolate Animal Cookies because they may contain undeclared soy lecithin.
Siemens Healthcare Diagnostics is recalling Dimension Glucose assays because they may produce inaccurate results when used with certain drugs.
Baxter Healthcare is recalling 444 Sigma Spectrum Infusion Pumps because technicians omitted required safety tests, potentially compromising air and occlusion detection.
Microline Surgical is recalling specific lots of ReNew Endocut Scissor Disposable Tips because the sterile barrier may be compromised.
Cook Inc. is recalling 886 connecting tubes because the cap-adapter assembly may not be adequately tightened, potentially leading to fluid leakage or air aspiration.
TP Orthodontics is recalling Jasper Vektor Class II Correction Appliances because the devices may break in the patient's mouth, posing a risk of injury.
Vyaire Medical is recalling 4,640 AirLife Infant Resuscitation Devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.
Vygon U.S.A. is recalling 16,520 PICC Insertion Trays because potential friction holes may affect the product's sterility.
Baxter Healthcare is recalling 444 Sigma Spectrum Infusion Pumps because technicians incorrectly documented that all final release tests were completed, when several were actually omitted.
National Foodworks Services is voluntarily recalling Soozie's Doozies Sugar Cinnamon Snickerdoodle Cookie Dough due to contamination with Staphylococcus aureus.
Vygon U.S.A. is recalling the Maximum Barrier Tray (Product Code AMS-9018CP) because potential friction holes may compromise product sterility.
Bob's Red Mill is recalling 100% Whole Wheat Bread Mix because the label fails to declare wheat, a major allergen.
Vygon U.S.A. is recalling 16,520 PICC Trays because potential friction holes may affect the sterility of the product.
Zimmer Biomet is recalling specific lots of Gentle Threads Interference Screws because they were overexposed to ethylene oxide sterilization, which may compromise the sterile barrier.
Cook Inc. is recalling 554 connecting tubes because the cap-adapter assembly may not be adequately tightened, potentially leading to fluid leakage or air aspiration.
Dr. Reddy's Laboratories is recalling Metoprolol Succinate Extended-Release Tablets because a foreign Clopidogrel tablet was found in a bottle.
Kent Quality Foods is recalling approximately 308,430 pounds of hot dog and sausage products because they contain undeclared soy, a known allergen.
Vyaire Medical is recalling 4,500 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.
Siemens Medical Solutions is recalling 92 units of Syngo.plaza software to fix date formatting and annotation issues that could lead to patient misdiagnosis.
Medtronic is recalling 39 ZEVO Anterior Cervical Plate System slot screws because they are 15mm long instead of the specified 17mm.
Vitalab Pharmacy is recalling specific lots of sterile injectable drugs because airflow patterns may not support aseptic production.
Ziegenfelder Company is recalling Sugar Free Twin Pops after Listeria monocytogenes was found in environmental samples at their Denver plant.
Siemens Healthcare Diagnostics is recalling specific IMMULITE assay lots because the instructions for use do not list the biotin concentration that causes interference, posing a risk of inaccurate test results.
Ninepoint Medical is recalling 152 NvisionVLE Low-Profile Optical Probes because the distal tips may detach from the probe shaft during use.
TP Orthodontics is recalling Jasper Vektor Class II Correction Appliances because the devices may break in the patient's mouth, posing a risk of injury.
TP Orthodontics is recalling Jasper Vektor Class II Correction Appliances because the devices have broken in patients' mouths, posing a risk of injury.
Cook Inc. is recalling 304 connecting tubes because the cap-adapter assembly may not tighten adequately, potentially causing fluid leakage or air aspiration.
Boston Scientific is recalling 60,538 units of Capio SLIM Box 5 sutures because they may break or detach during open surgery.
DePuy Orthopaedics is recalling a specific femoral revision implant because burrs may be present on the extraction hole threads.
TP Orthodontics is recalling 126 Jasper Vektor Class II Correction Appliances because the devices may break in the patient's mouth, posing a risk of injury.
Siemens Healthcare Diagnostics is recalling IMMULITE Vitamin B12 assays because biotin interference is not listed in the instructions for use.
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