Archive
1,186 recalls were announced in September 2015.
Of the 1,186 recalls this month scored against our rubric, 10% are Critical, 47% are Severe.
Which agencies issued them
The Compounding Pharmacy of America is recalling Nandrolone Decanoate 200 mg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Testosterone Enanthate 200 mg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.
Stryker Orthobiologics is recalling 9,805 Aliquot Delivery Kits because two instances of holes were found in the sterile packaging, which could compromise sterility.
Fiat is recalling 2015 500L vehicles because the passenger air bag may not deploy correctly, increasing injury risk in a crash.
The Compounding Pharmacy of America is recalling LIPO-VITE Injection vials because an FDA inspection found GMP violations that may affect sterility.
Nico Corp. is recalling six Myriad Console units because twisted cables may cause wire breaks or shorts, leading to unexpected aspiration increases during surgery.
Edwards Lifesciences is recalling pressure monitoring kits due to flow restriction in the IV set, which may prevent system priming or line flushing.
Biomet 3i is recalling 61 UCLA Abutment Hexed Castable Cylinders because they were mislabeled as a different model. The error affects one specific lot distributed worldwide.
Boston Scientific is issuing a field correction for WATCHMAN Left Atrial Appendage Closure Devices to prevent hemostasis valve cross-threading and potential blood leakage.
Siemens is recalling ACUSON SC2000 ultrasound systems because a software error prevents the capture of images or clips when patient names are registered with different capitalization.
Apotex Inc. is recalling Cevimeline Hydrochloride Capsules, 30 mg, because the product may not meet specification limits for assay testing.
Med Tec Inc is recalling CIVCO Shoulder Retractors because the wrist straps used for patient positioning are too long.
EMD Serono is recalling specific lots of Clomiphene Citrate tablets because the active ingredient failed due to chemical contamination.
MedtestDx, Inc. is recalling 79 kits of MedTest DX Control Reconstitution Fluid due to vial fill volume variations that may cause control results to fall outside suggested ranges.
Hospira is recalling 83,320 vials of Ketamine Hydrochloride Injection because customer complaints reported cracked and leaking glass vials.
Fujifilm Medical Systems U.S.A., Inc. is recalling 256 endoscope operation manuals because the suction button may become stuck after using x-ray contrast agents.
Advanced Sterilization Products is reminding customers to follow rinsing instructions for CIDEX OPA Solution to ensure proper disinfection of medical devices.
RaySearch Laboratories is recalling RayStation software due to a floating-point precision error that affects the display of isodose lines and color tables.
Akorn, Inc. is recalling 370 kits of IC-Green (indocyanine green for injection) because a low out-of-specification potency result was found.
Leica Microsystems is recalling 901 tissue processors due to incorrect internal wiring that may prevent remote alarms from functioning during instrument failure.
Novartis Pharmaceuticals Corp. is recalling 10,767 bottles of Dexmethylphenidate HCl Extended-Release capsules because stability testing showed the product failed to meet dissolution specifications.
Pointe Scientific is recalling autoHDL Reagent H7545 because crystals may be present in the R1 reagent, potentially resulting from freezing during transport.
Pointe Scientific is recalling 93 kits of Creatinine Reagent C7539-150 because the R1 and R2 reagent bottles are mislabeled, which prevents valid test results.
KYMCO is recalling 2015 Super 8-50 X and Super 8-150 X scooters because the front brake hose may contact the tire, risking brake failure and crashes.
Suzuki is recalling 2012-2013 SX4 vehicles because the power steering pump may seize, causing loss of steering assist and increasing crash risk.
Crossroads is recalling 2015-2016 Sunset Trail trailers because kitchen ranges lack an isolation panel, creating a risk of fire, explosion, or carbon monoxide buildup.
Daimler Trucks North America is recalling 2014-2016 Freightliner trucks because rear brake calipers may contact the spring suspension, reducing braking performance.
Newmar is recalling specific Dutch Star, Dutch Aire, and King Aire motorhomes because a flexible exhaust tube may tear, allowing hot exhaust to contact other components and increase fire risk.
Michelin is recalling specific X Works XZY tires because they lack required DOT symbols and load range letters, which may cause confusion with non-compliant tires.
Henderson Wheel is recalling torsion arm assemblies where the arm is too small for its housing, posing a risk of trailer detachment and loss of control.
Eaton is recalling specific FR-Series 10-speed manual transmissions because the reverse gear may stay engaged, causing the vehicle to move backwards unexpectedly.
Motor Coach Industries is recalling 145 model year 2015 D4000, D4005, D4500, and D4505 vehicles because an incorrectly assembled fuse block may cause arcing and increase the risk of a fire.
Winnebago is recalling 172 model year 2015-2016 Itasca Sunova and Winnebago Sightseer motorhomes because a wiring harness may be damaged, increasing the risk of fire.
Mitsubishi is recalling 2011 Outlander Sport vehicles manufactured on December 3, 2010, due to incorrect certification labels lacking the correct VIN. Dealers will install corrected labels free of charge.
Toyota is recalling 2009-2012 RAV4 and 2012-2014 RAV4 EV vehicles because water dripping on the wiper joint may cause corrosion and linkage separation, reducing visibility.
Triple E is recalling 2016 Libero and Serenity recreational vehicles because a screw may become electrically charged, posing a shock hazard.
Bed Handles Inc. is recalling about 113,000 portable bed handles that lack safety retention straps. The missing straps allow the handles to shift, creating gaps that pose a risk of entrapment, strangulation, and death.
USDA FSIS issued a public health alert for frozen, raw, stuffed chicken products from Aspen Foods due to confirmed Salmonella Enteritidis contamination.
The Land of Nod is recalling Follow the Herd mobiles because unraveling yarn poses an entanglement and strangulation risk to young children.
Zak Designs is recalling 26-ounce water bottles sold at Target because the inner plastic straw can break, posing a choking hazard. No injuries have been reported.
Jeni's Splendid Ice Creams LLC is recalling Oregon Fir ice cream in pint and gallon sizes due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams is recalling various sizes of Salty Caramel Ice Cream due to potential Listeria monocytogenes contamination. The recall covers products distributed in 18 US states.
Jeni's Splendid Ice Creams is recalling various sizes of Dark Chocolate Ice Cream due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams LLC is recalling Buttermilk, Grapefruit Frozen Yogurt products due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams is recalling Salty Vanilla Custard ice cream in 3-gallon buckets and pints due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams is recalling Spiced Purple Yam products due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams LLC is recalling specific ice cream products because they may be contaminated with Listeria monocytogenes.
Jeni's Splendid Ice Creams LLC is recalling Seven Layer Bar Ice Cream products due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams is recalling Cantaloupe & Sun Tea Sorbet products due to potential contamination with Listeria monocytogenes.
Jeni's Splendid Ice Creams is recalling Pfeffernusse Macaroon Sandwiches due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams LLC is recalling Eclair ice cream products due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams is recalling 3-gallon buckets of Buttermilk, Passion Fruit Frozen Yogurt due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams LLC is recalling Cedarwood Vanilla Ice Cream in various sizes due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams is recalling Sun-Popped Corn ice cream in pint and 3-gallon sizes due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams is recalling Blood Orange Sorbet products due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams LLC is recalling Black Walnut Divinity ice cream in 3-gallon buckets and pints due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams is recalling Pfeffernusse ice cream sandwiches due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams is recalling Pineapple Cake Frozen Yogurt products due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams LLC is recalling Batdorf Coffee w/ Cream & Sugar ice cream in pint and 3-gallon sizes because the product may be contaminated with Listeria monocytogenes.
Jeni's Splendid Ice Creams is recalling Pistachio & Honey Ice Cream in various sizes due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams is recalling Red Raspberry Frozen Yogurt products due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams is recalling Buttermilk, Lime Cardamom Frozen Yogurt products due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams is recalling White House Blueberry Pints due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams LLC is recalling multiple sizes of Ndali Estate Vanilla Bean Ice Cream because the product may be contaminated with Listeria monocytogenes.
Jeni's Splendid Ice Creams LLC is recalling Brown Ice Cream products due to potential Listeria monocytogenes contamination. The recall covers 3-gallon buckets and pint containers distributed nationally.
Jeni's Splendid Ice Creams is recalling Wheatgrass, Pear, & Vinho Verde Sorbet due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams LLC is recalling various sizes of Lemon Buttermilk Frozen Yogurt because the product may be contaminated with Listeria monocytogenes.
Jeni's Splendid Ice Creams is recalling Watermelon Buttermilk Frozen Yogurt products due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams is recalling Dark Chocolate Hazelnut Macaroon Sandwiches due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams LLC is recalling Buttermilk, Mango Lassi Frozen Yogurt products due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams is recalling Sweet Cream Biscuits w/ Jam ice cream in 3-gallon buckets and pints due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams LLC is recalling Smoked Chocolate Buckets due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams LLC is recalling Riesling Poached Pear Sorbet in various sizes due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams is recalling Wintermint ice cream buckets due to potential Listeria monocytogenes contamination. The recall covers approximately 61,267 units distributed across 18 U.S. states.
Jeni's Splendid Ice Creams is recalling Buttermilk, Red Raspberry Frozen Yogurt products due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams LLC is recalling Cranberry Parfait Buttermilk Frozen Yogurt due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams is recalling Red Currant Cloverton ice cream in pint and gallon sizes due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams is recalling Gooey Buttercake ice cream products due to potential contamination with Listeria monocytogenes.
Jeni's Splendid Ice Creams is recalling Cherries Kickapoo ice cream products due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams is recalling Goat Cheese w/Red Cherries ice cream due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams LLC is recalling Cloverton ice cream products due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams is recalling Loveless Biscuits + Peach Jam ice cream products due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams LLC is recalling specific Black ice cream products because they may be contaminated with Listeria monocytogenes.
Jeni's Splendid Ice Creams is recalling Lemon & Blueberries Frozen Yogurt in various sizes due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams is recalling Grapefruit Frozen Yogurt pints due to potential Listeria monocytogenes contamination. The recall covers approximately 1.5 million units distributed nationally.
Jeni's Splendid Ice Creams LLC is recalling various sizes of Lemon Frozen Yogurt because the product may be contaminated with Listeria monocytogenes.
Jeni's Splendid Ice Creams LLC is recalling Orchid Vanilla Macaroon Sandwiches due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams LLC is recalling 3-gallon buckets of Guava Buttermilk Frozen Yogurt due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams LLC is recalling Sweet Cream Ice Cream in pint, half-gallon, and case formats due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams LLC is recalling Brambleberry Crisp ice cream in pint and 3-gallon sizes due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams LLC is recalling Mini Dark Chocolate Hazelnut Sandwiches and Sleeves due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams is recalling Roasted Strawberry Buttermilk Ice Cream in various sizes due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams is recalling 3-gallon Bananas & Honey Ice Cream buckets due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams is recalling Feuerzangenbowle Sorbet pints due to potential Listeria monocytogenes contamination. Consumers should discard or return the product.
Jeni's Splendid Ice Creams is recalling White Chocolate Coconut ice cream in pints and 3-gallon buckets due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams is recalling Key Lime ice cream products due to potential Listeria monocytogenes contamination. Consumers should discard the product or return it for a refund.
Jeni's Splendid Ice Creams is recalling Pfeffernusse ice cream buckets due to potential Listeria monocytogenes contamination.
Nectar Foods LLC is recalling CocoNoNut Cacao-Nectar Bars because they may contain undeclared almond. The product was distributed in Oregon and California.
Jeni's Splendid Ice Creams is recalling Black Currant Lambic Sorbet products due to potential Listeria monocytogenes contamination.
Jeni's Splendid Ice Creams is recalling Double-Toasted Coconut Ice Cream in 3-gallon buckets and pints due to potential Listeria monocytogenes contamination.
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