Archive
577 recalls were announced in June 2018.
Of the 577 recalls this month scored against our rubric, 3% are Critical, 25% are Severe.
Which agencies issued them
Angiodynamics Inc. is recalling 5 boxes of RS 5F DL XPP Kits because a component may contain unsafe levels of bacterial endotoxins.
Angiodynamics Inc. is recalling 3 boxes of RS - TANDEM 5F DL BIOFLO MIDLINE catheters because a component may contain unsafe levels of bacterial endotoxins.
Angiodynamics Inc. is recalling 104 boxes of RS 5F DL BIOFLO PASV kits because a component may contain unsafe levels of bacterial endotoxins.
Angiodynamics Inc. is recalling 17 boxes of Bio-Stable 5F kits because a component may contain unsafe levels of bacterial endotoxins.
Shadow Holdings DBA Bocchi Labs is recalling the Acne Shave 3 Step Shaving System due to CGMP deviations that may result in bacterial contamination.
Sun Med, LLC is recalling 350 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially allowing the port to detach during use and impacting air delivery.
Angiodynamics Inc. is recalling 11 boxes of RS 5F DL BIOFLO PASV kits because components may contain unsafe levels of bacterial endotoxins.
TRW is recalling air bag control units in certain Hyundai and Kia vehicles because electrical overstress may prevent air bags and seat belt pretensioners from deploying in a crash.
Sun Med, LLC is recalling 361 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially allowing the port to detach and impacting air delivery.
Pious Lion is recalling 4 oz bags of White Maeng DA Kratom because the North Carolina Department of Agriculture found the product contains Salmonella.
The Seaberg Company is recalling SAM XT-M tourniquets because internal testing found stitches securing the buckle could fail, posing a risk of serious injury or death.
Angiodynamics Inc. is recalling 2 boxes of RS 5F DL BIOFLO PASV kits because components may contain unsafe levels of bacterial endotoxins.
Philips is recalling 20 Brilliance 16 P CT systems because the patient support head holder may contact the back ISO shelter wall, posing a risk of serious injury.
Allergan is recalling Taytulla softgel capsules because the tablets are out of sequence. This affects 168,768 blister cards distributed nationwide.
The Seaberg Company is recalling SAM XT-C tourniquets because internal testing showed stitches securing the buckle might fail, posing a risk of serious injury or death.
Medline Industries is recalling specific lots of READYFLUSH PROTECT flushable personal cleaning cloths because of microbial contamination in a non-sterile product.
Shadow Holdings DBA Bocchi Labs is recalling X-Jow Pain Gel because CGMP deviations may have allowed bacterial contamination.
Sun Med, LLC is recalling 1,742 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially allowing the port to detach during use and impacting air delivery.
Shadow Holdings DBA Bocchi Labs is recalling Acne Shave Shave Cream due to CGMP deviations that may allow bacterial contamination.
Philips is recalling two Brilliance 16 CT systems because the patient support head holder may contact the back ISO shelter wall, posing a risk of serious injury.
Inopak Ltd is recalling Option Systems Antibacterial Foaming Hand Wash because FDA analysis found out-of-specification microbial counts.
H-E-B is recalling Hill Country Fare Neapolitan ice cream in Texas and Mexico because it may contain broken metal pieces.
Angiodynamics Inc. is recalling 7 boxes of RS 5F DL BIOFLO PASV kits because components may contain unsafe levels of bacterial endotoxins.
H-E-B is recalling EconoMax Vanilla ice cream in Texas and Mexico due to potential broken metal pieces.
Angiodynamics Inc. is recalling BioFlo PICC Nursing Kits because a component may contain unsafe levels of bacterial endotoxins.
Angiodynamics Inc. is recalling 15 boxes of RS TANDEM 5F DL BIOFLO PICC kits because components may contain unsafe levels of bacterial endotoxins.
H-E-B is recalling EconoMax Neopolitan ice cream in Texas and Mexico because it may contain broken metal pieces.
Angiodynamics Inc. is recalling 50 boxes of Bio-Stable 5F kits because components may contain unsafe levels of bacterial endotoxins.
H-E-B is recalling Hill Country Fare Fudge Revel 4.5 quarts because the product may contain broken metal pieces.
PharMEDium Services is recalling 2,800 hydromorphone syringes nationwide because some units were found to be superpotent or subpotent.
Angiodynamics Inc. is recalling BioFlo PICC nursing kits because a component may contain unsafe levels of bacterial endotoxins.
Angiodynamics Inc. is recalling RS 5F DL XPP kits because a component may contain unsafe levels of bacterial endotoxins.
The Seaberg Company is recalling SAM XT-C tourniquets because internal testing showed stitches securing the buckle could fail, posing a risk of serious injury or death.
Angiodynamics Inc. is recalling 36 boxes of 5F DL BIOFLO PASV kits because components may contain unsafe levels of bacterial endotoxins.
Angiodynamics Inc. is recalling BioFlo PICC nursing kits because a component may contain unsafe levels of bacterial endotoxins.
Sun Med, LLC is recalling 113 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially allowing the port to detach during use.
Angiodynamics Inc. is recalling 298 boxes of Bio-Stable 5F kits because a component may contain unsafe levels of bacterial endotoxins.
Angiodynamics Inc. is recalling 13 boxes of RS Tandem 5F DL Xcela PICC catheters because a component may contain unsafe levels of bacterial endotoxins.
Angiodynamics Inc. is recalling 12 boxes of RS 5F DL BIOFLO PICC kits because a component may contain unsafe levels of bacterial endotoxins.
Maquet Cardiopulmonary Ag is recalling specific lots of Aortic Arterial Cannulas because the de-airing plugs may break during removal.
Angiodynamics Inc. is recalling 17 boxes of CAN 5F SINGLE XCELA PICC kits because a component may contain unsafe levels of bacterial endotoxins.
Angiodynamics Inc. is recalling 2 boxes of CAN 5F DL BIOFLO PASV PICC Nursing Trays because a component may contain unsafe levels of bacterial endotoxins.
Roche Diabetes Care is recalling specific lots of Accu-Chek Aviva Plus test strips because they may produce biased results or fail to detect blood, potentially leading to incorrect user actions.
Angiodynamics Inc. is recalling BioFlo Midline kits because a component may contain unsafe levels of bacterial endotoxins.
Angiodynamics Inc. is recalling Bio-Stable 5F kits because a component may contain unsafe levels of bacterial endotoxins.
Zimmer Biomet is recalling 16 units of 75mm tibial tray implants that may be incorrectly labeled as 79mm. This error could lead to surgical delays or the need for immediate revision surgery.
Roche Diabetes Care is recalling Accu-Chek Performa test strips because they may produce biased results or fail to detect blood samples, potentially leading to incorrect user actions.
Sun Med, LLC is recalling 60 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially allowing the port to detach during use.
Ion Beam Applications S.A. is recalling 12C medical devices because using non-IBA accessories or unauthorized modifications may pose a safety risk.
Shearers Foods is recalling Meijer Dill Pickle Flavored Classic Crunch Potato Chips because milk was not declared on the label.
Siemens Healthcare Diagnostics is recalling specific lots of Dimension Gentamicin Flex reagent cartridges because they may produce inaccurate test results at the low end of the measurement range.
Angiodynamics Inc. is recalling Bio-Stable 5F kits because components may contain unsafe levels of bacterial endotoxins.
New Century Snacks LLC is recalling Tropical Trail Mix because some bags contain Yogurt Trail Mix, which includes undeclared milk, soy, wheat, and cashews.
Datascope Corporation is recalling 27 pediatric cardiopulmonary bypass tubing kits because the over-pressure safety valve may fail to allow flow.
Sun Med, LLC is recalling STAT-Check Manual Resuscitators because the patient port retaining ring may not fully seat, allowing the port to detach and impact air delivery.
Bugatti is recalling 2018 Chiron vehicles because an incorrectly installed heat shield may reduce side air bag performance, increasing injury risk.
Angiodynamics Inc. is recalling 27 boxes of CAN 5F Dual Xcela PICC kits because a component may contain unsafe levels of bacterial endotoxins.
Sun Med, LLC is recalling 40 cases of Medline Adult Manual Resuscitators because a retaining ring may not seat fully, allowing the patient port to detach and impact air delivery.
Angiodynamics Inc. is recalling 20 boxes of RS TANDEM 5F DL BIOFLO PASV catheters because a component may contain unsafe levels of bacterial endotoxins.
H-E-B is recalling Hill Country Fare Vanilla ice cream in 4.5-quart containers because the product may contain broken metal pieces.
H-E-B is recalling Rainbow Sherbet quarts because they may contain broken metal pieces. The product was distributed in Texas and Mexico.
Divvies LLC is recalling 447 Semi-Sweet Peppermint Bars sold nationwide online because the product may contain traces of milk.
Angiodynamics Inc. is recalling 7 units of RS TANDEM 5F DL XPP kits because components may contain unsafe levels of bacterial endotoxins.
Sun Med, LLC is recalling 60 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, allowing the port to detach and impact air delivery.
H-E-B is recalling Hill Country Fare Cookies and Cream cookies because they may contain broken metal pieces.
Gillig is recalling 2001-2018 Low Floor transit buses because turn signals may flash slowly, reducing visibility and increasing crash risk.
Ion Beam Applications is recalling Proteus ONE and Proteus Plus medical devices because unauthorized modifications or third-party accessories may pose a safety risk.
Werner is recalling about 78,000 telescoping aluminum ladders because they can break while in use, posing a fall hazard.
SDQ Trading Inc. is recalling BISCUIT FOOD Cheese Biscuits because the product contains undeclared milk. The recall affects retailers in New York.
Meijer is voluntarily recalling Dark Chocolate Covered Almonds because the product contains undeclared coconut, a major food allergen.
Morley Candy Makers is recalling Sanders Milk Chocolate Covered Fudge Bites because they contain undeclared almonds, a tree nut allergen.
H-E-B is recalling Orange & Cream Swirl Sherbet quarts because they may contain broken metal pieces.
H-E-B is recalling Hill Country Fare Strawberry Revel 4.5 quarts because the product may contain broken metal pieces.
Shadow Holdings DBA Bocchi Labs is recalling Acne Shave Post-Shave Moisturizer because products may be contaminated with bacteria due to CGMP deviations.
H-E-B is recalling specific quart containers of Creamy Creations Strawberry & Cream Swirl Sherbet because they may contain broken metal pieces.
Sugarfina is recalling Sugar Cookies due to an undeclared egg allergen. The product was distributed in the U.S. and the United Arab Emirates.
Newly Weds Foods Inc is recalling specific lots of commercial breaders and batters because they may contain foreign plastic material.
Roche Diagnostics is recalling 35 cobas e 801 immunoassay analyzers because a tilted syringe plunger may crack, leading to impaired syringe function.
Angiodynamics Inc. is recalling 23 boxes of BioFlo Midline kits because a component may contain unsafe levels of bacterial endotoxins.
Angiodynamics Inc. is recalling 20 boxes of Bio-Stable 5F kits because a component may contain unsafe levels of bacterial endotoxins.
Siemens Healthcare Diagnostics is recalling specific lots of Dimension Vista Gentamicin Flex reagent cartridges because they may produce inaccurate results at low concentrations.
H-E-B is recalling 18,630 quarts of No Sugar Added Strawberry Sherbet because the product may contain broken metal pieces.
Sun Med, LLC is recalling 80 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially causing the port to detach and impacting air delivery.
H-E-B is recalling Hill Country Fare Chocolate 4.5 quarts because the product may contain broken metal pieces.
Angiodynamics Inc. is recalling BioFlo PICC nursing kits because a component may contain unsafe levels of bacterial endotoxins.
Angiodynamics Inc. is recalling RS Tandem 5F DL Bioflo Pasv catheters because components may contain unsafe levels of bacterial endotoxins.
Shimadzu Medical Systems is recalling 17 Sonialvision Safire II angiographic x-ray systems because the irradiation time and integral dose displays may reset to zero during serial radiography.
Sun Med, LLC is recalling 30 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially allowing the port to detach and impacting air delivery.
Angiodynamics Inc. is recalling Bio-Stable 5F kits because components may contain unsafe levels of bacterial endotoxins.
R.A.B. Food Group LLC is recalling Manischewitz Dark Chocolate covered Potato Chips due to undeclared peanut, tree nut, and milk allergens.
H-E-B is recalling 11,670 quarts of Creamy Creations Fruit Punch Sherbet because the product may contain broken metal pieces.
Maquet Cardiopulmonary Ag is recalling specific lots of Aortic Arterial Cannulas because the de-airing plugs may break during removal.
Angiodynamics Inc. is recalling Xcela 5FDL-55cm Maximal Barrier Nursing Kits because a component may contain unsafe levels of bacterial endotoxins.
Datascope Corporation is recalling eight Maquet Cardiopulmonary Bypass Custom Tubing kits because the over-pressure safety valve may fail to allow flow.
Datascope Corporation is recalling 10 units of Maquet Cardiopulmonary Bypass Custom Tubing kits because the over-pressure safety valve may fail to allow flow.
Angiodynamics Inc. is recalling 86 boxes of Microintroducer Kits because a component may contain unsafe levels of bacterial endotoxins.
Sun Med, LLC is recalling 110 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially detaching the port and impacting air delivery to the patient.
H-E-B is recalling Creamy Creations No Sugar Added Orange Sherbet quarts because they may contain broken metal pieces.
Roche Diabetes Care is recalling Accu-Chek Inform II test strips because they may produce errors or biased results, potentially leading to incorrect user actions.
Zeiss is recalling specific laser scanning microscopes because the laser shutter may not close completely, allowing reflected beams to exceed Class I safety limits.
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