Archive
831 recalls were announced in August 2019.
Of the 831 recalls this month scored against our rubric, 2% are Critical, 30% are Severe.
Which agencies issued them
Wise Pharmacy is recalling Acetylcysteine 2% Otic Drops due to a lack of processing controls. The product was distributed in Colorado, Texas, and Wyoming.
Bento Sushi is recalling specific bowls of fully cooked pink salmon in teriyaki sauce because they may contain small metal fragments.
ImprimisRx NJ is recalling 246 bottles of Timolol-Dorzolamide-Latanoprost ophthalmic drops because the medication was found to be subpotent.
Wise Pharmacy is recalling 14 vials of compounded Papaverine/Phentolamine/Alprostadil/Atropine injectable due to a lack of processing controls.
Burlington Medical is recalling seven Overlap Vests because the protective material may provide inadequate protection against scatter radiation.
Growers Express is recalling Green Giant Fresh Butternut Squash Diced due to a positive Listeria monocytogenes test result.
Burlington Medical is recalling 2,190 thyroid collars because the protective material may provide inadequate protection against scatter radiation, potentially exposing users to increased health risks.
GE Healthcare is recalling 82 Senographe Pristina mammography systems because the biopsy positioner may slip when the gantry is rotated during a procedure.
Elekta Inc is recalling Monaco RTP System software versions 5.10 and 5.11 due to a defect that causes incorrect Monitor Unit scaling when specific plan parameters are changed.
Burlington Medical is recalling Porta Shield radiation protection products because the material may provide inadequate protection against scatter radiation.
Burlington Medical is recalling 23 Frontal Quick Drop OR Aprons because the protective material may provide inadequate protection against scatter radiation.
Burlington Medical is recalling 51 Full Wrap Support Belt Aprons because the protective material may provide inadequate protection against scatter radiation.
Burlington Medical is recalling 210 thyroid collars because the protective material may provide inadequate protection against scatter radiation, potentially exposing users to increased health risks.
ImprimisRx NJ is voluntarily recalling 405 bottles of Timolol-Latanoprost P-F ophthalmic drops because the medication was found to be subpotent.
Tropical Nut & Fruit Company is recalling Truly Good Foods Edamame Beans because the label is missing the required allergen statement.
Burlington Medical is recalling 48 radiation protection aprons because the protective material may provide inadequate shielding, potentially exposing users to scatter radiation.
Encore Medical is recalling 21 Flexible Drill Shafts because a manufacturing error may prevent the shaft from capturing the drill bit pin, potentially causing the bit to come loose during surgery.
Super Store Industries is recalling Sunnyside Farms Peach Yogurt due to potential coconut contamination. The product was distributed in California.
Burlington Medical is recalling two half aprons because the protective material may provide inadequate protection against scatter radiation, potentially exposing users to higher radiation levels.
Growers Express is recalling fresh butternut squash due to a positive Listeria monocytogenes test result from a random sample.
Dolfin S.A. is recalling Dark Chocolate with Pink Peppercorns because the product may contain undeclared milk. Consumers with milk allergies should not eat the product.
Growers Express is recalling Trader Joe's Zucchini Spirals after a positive Listeria monocytogenes test result was reported by the Massachusetts Department of Public Health.
Burlington Medical is recalling three radiation protection hoods because the protective material may not adequately shield users from scatter radiation.
Inovo, Inc. is recalling 690 Single Luman Conservers because the pressure gauge may dislodge from the mount, creating a leak.
Growers Express is recalling Green Giant Fresh Brussels Sprouts after a positive Listeria monocytogenes test result was found in a retail sample.
Burlington Medical is recalling nine Frontal Stretch Buckle Closure Aprons because the protective material may provide inadequate protection against scatter radiation.
Growers Express is recalling Signature Farms Cauliflower Crumbles after a positive Listeria monocytogenes test result from a Massachusetts retail sample.
Burlington Medical is recalling Frontal Aprons with Quick Drop Velcro Closure because the protective material may provide inadequate protection against scatter radiation.
Terumo is recalling 52 Capiox NX19 Oxygenators because they may contain a non-functioning arterial thermistor component.
GE Healthcare is recalling 16 Pristina Serena breast biopsy accessories because the positioner may slip when the machine rotates during a procedure.
Wilson-Cook Medical is recalling Acuject Variable Injection Needles due to a potential for occluded needles. The affected units were distributed to China.
Growers Express is recalling Green Giant Fresh Butternut Squash Cubed due to a positive Listeria monocytogenes test result from a retail sample.
Burlington Medical is recalling 39 radiation protection sleeves because the material may provide inadequate protection against scatter radiation.
Centurion Medical Products is recalling 80 Sheridan Endotracheal Tubes due to an increased incidence of the connector becoming disconnected from the tube.
Burlington Medical is recalling 37 radiation protection kilts because the protective material may provide inadequate shielding against scatter radiation.
Burlington Medical is recalling 49 radiation protection caps because the protective material may not adequately shield users from scatter radiation.
Burlington Medical is recalling 807 thyroid collars because the protective material may provide inadequate protection against scatter radiation, potentially increasing long-term health risks.
Teleflex Medical is recalling 3,700 Rusch EasyCath Kits because they may not be sterile. The kits were distributed nationwide to eight states.
Growers Express and Peak cauliflower florets are recalled after a positive Listeria monocytogenes test result from a Massachusetts retail sample.
Growers Express and Peak cauliflower florets are being recalled after a positive Listeria monocytogenes test result was found in a random sample.
Burlington Medical is recalling 104 Frontal Apron Velcro Closures because the protective material may provide inadequate protection against scatter radiation.
Burlington Medical is recalling 310 two-piece full wrap vests and kilts because the protective material may provide inadequate shielding against scatter radiation.
Burlington Medical is recalling 23 thyroid collars because the protective material may provide inadequate protection against scatter radiation, potentially increasing health risks for users.
Growers Express is recalling Trader Joe's Butternut Squash Spirals after a positive Listeria monocytogenes test result was found in a random sample.
Burlington Medical is recalling two radiation protection aprons because the protective material may provide inadequate shielding, potentially exposing users to scatter radiation.
Burlington Medical is recalling 129 two-piece radiation protection vests and kilts because the protective material may provide inadequate shielding against scatter radiation.
Burlington Medical is recalling six Frontal Support Belt Aprons because the protective material may provide inadequate protection against scatter radiation.
Diversified Foods and Seasonings LLC is recalling frozen macaroni and cheese due to a risk of choking from plastic foreign material.
Burlington Medical is recalling 332 lead apron products because the protective material may provide inadequate protection against scatter radiation.
Burlington Medical is recalling seven Peak Vests because the protective material may provide inadequate protection against scatter radiation, potentially exposing users to higher radiation levels.
Terumo is recalling 16 Capiox NX19 Oxygenators with a non-functioning arterial thermistor component. The units were distributed in Michigan, Japan, and Belgium.
Siemens Healthcare Diagnostics Inc is recalling Stratus CS Acute Care cTNI TestPaks due to a potential for increased false positive results.
Burlington Medical is recalling 22 radiation protection vests because the protective material may provide inadequate shielding against scatter radiation.
Growers Express is recalling Green Giant Fresh Ramen Soup Bowls after a positive Listeria monocytogenes test result from a Massachusetts retail sample.
Seattle Manufacturing Corporation is recalling Kobah Ice Axes because the spike or head can detach from the handle, posing serious injury and fall risks.
Terumo is recalling 78 Capiox NX19 Oxygenators exported to Japan and Belgium because they may contain a non-functioning arterial thermistor component.
Growers Express is recalling Green Giant Cauliflower Sweet Potato Crumbles after a positive Listeria monocytogenes test result was found in a retail sample.
Growers Express is recalling Green Giant Fresh Zucchini Noodles after a positive Listeria monocytogenes test result from a Massachusetts retail sample.
Pharma Pac is recalling specific lots of Neomycin Ophthalmic Ointment due to insufficient quality assurance controls in the manufacturing facility.
Wise Pharmacy is recalling 84 vials of compounded Papaverine/Phentolamine/Alprostadil injectable due to a lack of processing controls.
Wise Pharmacy is recalling 32 vials of compounded Papaverine/Phentolamine/Alprostadil injectable due to a lack of processing controls. The product was distributed in Colorado, Texas, and Wyoming.
Wise Pharmacy is recalling specific lots of compounded Papaverine/Phentolamine/Alprostadil injectable vials due to a lack of processing controls.
Wise Pharmacy is recalling 27 vials of Dexamethasone Sodium Phosphate Injection because of a lack of processing controls. The product was distributed in Colorado, Texas, and Wyoming.
Wise Pharmacy is recalling Tobramycin Irrigation 80 mg/1000 mL Solution due to a lack of processing controls. The product was distributed in Colorado, Texas, and Wyoming.
Wise Pharmacy is recalling Alprostadil 100 mcg/mL Injectable vials due to a lack of processing controls. The product was distributed in Colorado, Texas, and Wyoming.
Wise Pharmacy is recalling 97 vials of compounded Papaverine/Phentolamine/Alprostadil injectable due to a lack of processing controls.
Alto Development Corp is recalling Ultra-Flex MYO/Wire pacing wires to update instructions for use to ensure consistency with the M-21 loop electrode.
Piramal Critical Care is recalling Gablofen (baclofen injection) due to the presence of an unknown impurity observed during shelf life.
Philips is recalling 229 Azurion Interventional Fluoroscopic X-ray Systems because a software defect may cause radiation levels too low for diagnostic images.
Agfa N.V. is recalling four DR 800 digital radiography systems because the exposed area of fluoroscopic exams may not match the active detector area.
NingBo Huize Commodity Co., Ltd. is recalling 20,160 units of Pink Lemonade Scented Antibacterial Hand Gel because stability testing was not conducted.
Hycor Biomedical Inc is recalling 207 units of the AUTOSTAT II IgM Rheumatoid Factor test kit due to reports of higher than anticipated positivity rates, which may cause false positive results.
NingBo Huize Commodity Co., Ltd. is recalling Tootsie Roll POP Orange Scented Antibacterial Hand Gel because stability testing was not conducted.
Lupin Pharmaceuticals is recalling Kaitlib Fe chewable tablets because long-term stability testing showed out-of-specification impurities or degradation.
Wise Pharmacy is recalling Gentamicin Irrigation Solution due to a lack of processing controls. The affected product was distributed in Colorado, Texas, and Wyoming.
NingBo Huize Commodity Co., Ltd. is recalling ICEE Peach Scented Antibacterial Hand Gel because stability testing was not conducted on the product.
Major Pharmaceuticals is recalling 828 cartons of Divalproex Sodium Extended-Release Tablets because they were exposed to high humidity during packaging.
Wise Pharmacy is recalling 8 vials of Papaverine/Phentolamine Injectable due to lack of processing controls. The product was distributed in Colorado, Texas, and Wyoming.
American Health Packaging is recalling Doxycycline Hyclate 100 mg tablets because they failed to meet dissolution specifications. The affected lot was distributed nationwide.
Ralston Group is recalling 534 Maximum Pelvic Trainer units because the device was incorrectly listed with the FDA and lacks a required 510(k) submission.
NingBo Huize Commodity Co., Ltd. is recalling Tootsie Roll Fruit Chews Vanilla Scented Antibacterial Hand Gel because stability testing was not conducted.
NingBo Huize Commodity Co., Ltd. is recalling ICEE Lemon Lime Scented Antibacterial Hand Gel because stability testing was not conducted on the product.
NingBo Huize Commodity Co., Ltd. is recalling DOTS Scented Antibacterial Hand Gel Lime because stability testing was not conducted on the product.
NingBo Huize Commodity Co., Ltd. is recalling 35,500 units of Accent Care hand sanitizer because stability testing was not conducted.
NingBo Huize Commodity Co., Ltd. is recalling SPF 30 Sunscreen Lotion because stability testing was not conducted on the manufactured product.
NingBo Huize Commodity Co., Ltd. is recalling 50,000 units of hand sanitizer because stability testing was not conducted.
NingBo Huize Commodity Co., Ltd. is recalling Tootsie Roll POP Chocolate Scented Antibacterial Hand Gel because stability testing was not conducted.
NingBo Huize Commodity Co., Ltd. is recalling CHARMS Blow Pop Cherry Scented Antibacterial Hand Gel because stability testing was not conducted on the product.
NingBo Huize Commodity Co., Ltd. is recalling Tootsie Roll POP Grape Scented Antibacterial Hand Gel because stability testing was not conducted.
NingBo Huize Commodity Co., Ltd. is recalling CHARMS Blow Pop Scented Antibacterial Hand Gel because stability testing was not conducted on the OTC products.
NingBo Huize Commodity Co., Ltd. is recalling Good to Go Hand Sanitizer because stability testing was not conducted on the product.
NingBo Huize is recalling Dippin' Dots Scented Birthday Cake Antibacterial Hand Gel because stability testing was not conducted on the product.
NingBo Huize Commodity Co., Ltd. is recalling Dubble Bubble Scented Antibacterial Hand Gel because stability testing was not conducted on the product.
NingBo Huize Commodity Co., Ltd. is recalling Dippin' Dots Scented Antibacterial Hand Gel because stability testing was not conducted on the product.
NingBo Huize Commodity Co., Ltd. is recalling Tootsie Roll Fruit Chews Lime Scented Antibacterial Hand Gel because stability testing was not conducted.
NingBo Huize Commodity Co., Ltd. is recalling Dots Scented Antibacterial Hand Gel because stability testing was not conducted on the product.
NingBo Huize Commodity Co., Ltd. is recalling ICEE Cherry Scented Antibacterial Hand Gel because stability testing was not conducted on the product.
Xhale Assurance is recalling 701,272 Nasal Alar SpO2 Sensors because the Instructions for Use are missing steps for checking and changing the application site.
NingBo Huize Commodity Co., Ltd. is recalling Lemon Hand Sanitizer because stability testing was not conducted on the product.
NingBo Huize Commodity Co., Ltd. is recalling ICEE Blue Raspberry Scented Antibacterial Hand Gel because stability testing was not conducted on the product.
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