Archive
771 recalls were announced in June 2021.
Of the 771 recalls this month scored against our rubric, 1% are Critical, 14% are Severe.
Which agencies issued them
The reSET Mobile App had a software defect that incorrectly granted patients access to rewards even with positive drug screens. This undermines the clinical logic of substance abuse treatment.
Cardinal Health is recalling 2,357 kits of Dexcom G6 Sensor 3-Pack due to temperature exposure during shipping that may cause inaccurate glucose readings. Affected units were distributed in Florida, Georgia, and South Carolina.
Cardinal Health is recalling Freestyle Lancets due to temperature exposure during shipping that may cause inaccurate results. Affected devices were distributed in Florida, Georgia, and South Carolina.
Exact Medical Manufacturing is recalling 33,250 ultrasonic transducer probe covers lacking required FDA 510(k) clearance for use in natural or surgical body openings, distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.
Exact Medical Manufacturing is recalling 1,600 ultrasonic probe covers distributed without FDA 510(k) clearance for use in body cavities and surgical openings. Users should discontinue use immediately.
Smith & Nephew is recalling 5 units of a knee prosthesis component due to surface damage from a manufacturing error. The affected lot was distributed in specific U.S. states.
GE Healthcare's Case Cardiac Assessment System and CardioSoft diagnostic application may display one patient's cardiac test report in another patient's medical record under certain conditions. No patient injuries have been reported.
O'Brien's Own Gourmet Granola blueberry muffin flavor is recalled because the product contains whey but does not declare milk on the label, creating a risk for consumers with milk allergies.
Exact Medical Manufacturing is recalling 12,650 ultrasonic probe covers (Item A-AU-0980N) that were marketed for use in body cavities without FDA 510(k) clearance.
Clio LLC is recalling Clio Mixed Berry Less Sugar Yogurt Bars due to possible metal fragments in the product. Consumers should not eat the affected bars and should contact the company or return them to the retailer.
BioFire BCID2 panels for FilmArray Systems are recalled due to manufacturing defects causing elevated rates of false negative results. Affected diagnostic kits may fail to detect infections in blood culture samples.
Concord Farms Fresh Enoki Mushrooms have been recalled because samples tested positive for Listeria monocytogenes. The affected product was distributed to California, Nevada, and Minnesota.
Cardinal Health is recalling AeroChamber PLS spacers exposed to freezing temperatures during shipping, which may cause inaccurate drug delivery results. Affected units shipped between February and March 2021 in Florida, Georgia, and South Carolina.
Exact Medical Manufacturing recalls 78,000 probe covers that lacked FDA premarket clearance. The product was distributed for use in body openings without required 510(k) approval.
Clio LLC is recalling Clio Strawberry Greek Yogurt Mini Bars (6.2 oz pouch x 6 pouches per case, UPC 854021008084) with best buy dates between 2/7/2021 and 6/27/2021 due to possible metal fragments.
Exact Medical Manufacturing recalls 10,020 units of Hays Ultrasound Kit (H1000SE) due to lack of FDA 510(k) clearance for use in body openings. The recall affects units in FL, MT, NY, OH, GA, and Puerto Rico.
Viona Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets 750 mg due to detection of N-Nitrosodimethylamine (NDMA) levels exceeding acceptable daily intake limits.
Exact Medical Manufacturing recalled 36,000 ultrasonic transducer probe covers due to missing FDA 510k premarket notification clearance. The affected units were distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.
Exact Medical Manufacturing is recalling 17,545 units of a 6" x 48" Elastic Poly Probe Cover that lacks FDA 510(k) clearance for use in body openings. The product should not be used without proper FDA pre-market approval.
Bausch Health Companies is recalling Mephyton (Phytonadione) 5 mg tablets nationwide because certain lots failed impurities and degradation specifications. Affected consumers should contact their healthcare provider.
John B. Sanfilippo & Son Inc. is recalling Favorite Day Peanut Butter Chocolate Trail Mix because some packages may contain stringy pieces of flexible plastic.
Cardinal Health is recalling ACCU-CHEK SMARTVIEW 100 test strips distributed in Florida, Georgia, and South Carolina due to temperature excursions during shipping that may cause inaccurate glucose readings.
Exact Medical Manufacturing is recalling ultrasonic probe covers due to missing FDA 510(k) clearance for use in natural or surgical body openings. The recall affects 8,800 units distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.
Teligent Pharma is recalling Diflorasone Diacetate Ointment USP 0.05% due to the presence of foreign particles found during routine stability testing. The recall affects 6,240 tubes distributed nationwide.
Larsen's Creamery, Inc. is recalling Bulk Salted Butter, item #502, due to an out-of-compliance HTST (High Temperature Short Time) recording chart. The recalled butter was made from pasteurized milk on 4/7/21 and distributed in Oregon and Washington.
John B. Sanfilippo & Son Inc. is recalling Favorite Day Caramel Cashew Trail Mix nationwide because the product may contain stringy pieces of flexible plastic.
SAN Corporation is recalling Tight! Xtreme Reloaded dietary supplement capsules because FDA inspection found an unapproved New Dietary Ingredient, Hordenine, in the product.
Inlightened Partners LLC is recalling 926 inLight Medical LED Pads due to improper assembly of cord connectors, which may cause power interruptions and controller shutdown.
Exact Medical Manufacturing recalled 5,621 ultrasonic transducer probe covers (Item A-AU-1002N) lacking FDA 510(k) clearance for use in natural or surgical body openings, distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.
Medical Action Industries is recalling Mosquito Hemostats due to potential flaking metal and brown spots on the devices. The recall affects 23 boxes of surgical instruments distributed nationwide.
Pacific Meridian Group is recalling Ful-Flav-R Green Pace Chili Diced due to reports of plastic pieces found in the product. The affected items were distributed in Texas.
Cardinal Health is recalling Vicks 1.5-gallon vaporizers exposed to temperature excursions during shipping delays in February-March 2021, which may cause inaccurate results. Affected units were distributed in Florida, Georgia, and South Carolina.
Bausch Health Companies is recalling Phytonadione 5 mg tablets distributed nationwide because the affected lots failed to meet impurity and degradation specifications. Consumers should consult their healthcare provider before stopping this medication.
East Manufacturing is recalling 2018-2021 MMX trailers because the steering arm may detach, potentially causing loss of steering control and increasing crash risk.
VanLeigh is recalling 2021-2022 Beacon recreational vehicles because a rear ladder can interfere with the rear egress window, preventing it from fully opening in emergencies.
Shenzhenshi Axi Technology is recalling OXILAM LED headlight bulbs sold on Amazon because they create excessive glare, failing federal safety standards.
Cummins is recalling specific L9 Diesel Engines because software calibration may allow excessive ammonia into the tailpipe, increasing injury risk.
Porsche is recalling certain 2020-2021 Taycan models due to a software monitoring fault that can incorrectly shut down the powertrain, causing loss of motive power and increasing crash risk.
Gillig is recalling 86 Low Floor buses from 2020-2021 because the rear axle may come out of alignment, increasing the risk of a crash.
Prevost is recalling 2021-2022 X3-45 Commuter buses because passenger seats may be improperly clamped, failing federal safety standards and increasing injury risk.
Heartland is recalling 2021 Pioneer SS171 travel trailers because the Federal Certification label lists incorrect weight ratings, which may lead to vehicle overload.
One More Auto Parts is recalling specific Lasfit aftermarket headlight bulbs sold on Amazon that are too bright for the first ten minutes of use, increasing crash risk.
Prevost is recalling 2021 X3 Commuter buses because an incorrect parking brake valve may cause the brake to release permanently, increasing crash risk.
Oshkosh is recalling 2019-2022 S-Series vehicles because they have 10-amp ABS fuses instead of the required 15-amp fuses, which may blow during braking and increase crash risk.
SVI Trucks is recalling 2017-2021 Rescue Trucks because a sealing washer may not seat correctly, allowing the high-pressure fuel rail to leak and increasing fire risk.
Daimler Trucks North America is recalling certain Freightliner and Western Star trucks because the battery cable terminal may break, causing engine stall and crash risk. Dealers will repair or replace the cables at no cost.
Mercedes-Benz is recalling 2016-2018 AMG GT vehicles because an insufficient bond between the carbon-fiber driveshaft and flange could cause separation, leading to loss of drive power and increased crash risk.
Mack Trucks is recalling 2020-2021 Granite vehicles because short suspension screws may separate, creating a road hazard and increasing crash risk.
Winnebago is recalling certain 2021-2022 Solis, Travato, and Ekko models equipped with GE-ES Double Flipseats because seat belt retractors may lock when the vehicle is on a slight incline, creating risk that passengers may feel trapped.
Mercedes-Benz is recalling certain 2021-2022 vehicles because rear seat belt automatic locking retractors may deactivate early, preventing child restraint systems from securing properly. An unsecured child restraint increases the risk of injury during a crash.
Roadtrek is recalling certain 2020-2021 Zion, Zion SRT, Play, and Slumber vehicles equipped with a faulty gas detector missing a carbon monoxide alarm. Undetected carbon monoxide can cause serious injury or death.
Forest River is recalling 2021 East to West Entrada motorhomes because the federal placard incorrectly lists six seat belts instead of four, potentially leaving passengers unsecured.
General Motors is recalling 2010-2016 Cadillac SRX and 2011-2012 Saab 9-4X vehicles because a rear suspension part may be loose, increasing crash risk.
Volvo Trucks North America is recalling one Watson and Chalin steerable lift axle suspension system because short screws may fail to engage locking nuts, creating a road hazard.
Mickey Truck Bodies is recalling certain 2017-2018 commercial trucks because the license plate light shines rearward instead of downward, potentially confusing other drivers.
General Motors is recalling certain 2021 Buick Enclave and Chevrolet Traverse vehicles due to potentially incorrect air bag calibration software that may affect frontal air bag deployment.
Plant Guru is recalling about 25,600 units of wintergreen, birch, and essential oil blend products because the packaging is not child-resistant despite containing methyl salicylate, which poses a poisoning risk if swallowed by young children.
Gramr is recalling about 92,135 Brushed Gold Tea Kettles because they can expel hot water and excessive steam during use, posing a burn hazard. The company has received 122 reports of the kettles expelling hot water or steam, including 18 reports of minor burn injuries.
Certain 2021 Nissan Rogue vehicles have improperly welded upper tether attachment points in the rear seat. This defect prevents child safety seats from being properly anchored, increasing injury risk during crashes.
La Paloma is recalling about 70 girls' nightgowns sold online from November through December 2020 because they fail to meet federal flammability standards for children's sleepwear, posing a burn hazard. No injuries have been reported.
Imperia Elita Vitaccino Coffee sachets are being recalled because they were marketed without FDA approval and contain pharmaceutical ingredients Sibutramine and Fluoxetine. All lots distributed nationwide are affected.
HMO Beverage Corp. dba Organic Gemini LLC is recalling Organic Gemini TigerNut Flour (27.5 lb bags) because the product may be contaminated with Salmonella. Consumers should not consume the affected product.
Olde Thompson and Sun Harvest are recalling 1.5oz. jars of organic ground coriander due to potential Salmonella contamination. Affected lots are 23631 and 23632 with best-before dates of 05/2023.
Natural Foods Inc is recalling BulkFoods.com brand dehydrated chopped celery in 1lb and 5lb bags due to potential Salmonella contamination. The affected product was distributed to multiple states.
Medtronic Vascular recalled 54,997 angiographic guidewire components that were shipped directly to customers without the required downstream processing and sterilization. The components should have been sent to a third-party processor first.
Daimler Coaches is recalling 530 Setra S407 and S417 coaches because a cracked engine flap hinge could cause the flap to detach, creating a road hazard.
Alexander Dennis is recalling 2017-2020 Enviro 500 buses because a sealing washer defect may cause high-pressure fuel leaks, increasing fire risk.
Volkswagen Group of America is recalling 2000-2002 Audi A4, S4, and 2000-2001 TT vehicles because driver airbag inflators may absorb moisture, potentially causing improper deployment in a crash.
The VENOVO Venous Stent System 8F may fail to expand properly upon deployment and remain connected to the delivery system, affecting approximately 12,258 devices worldwide including 7,234 in the United States.
Medtronic recalls Custom Perfusion System tubing packs due to incomplete welds in the manufacturing process that may affect device integrity.
Corin TriFit hip prosthesis components from lot 467881 were mislabeled, with size 2 stems labeled as size 7 and vice versa. Surgeons could implant incorrect components during hip replacement surgery.
The FDA is recalling VENOVO Venous Stent System units due to reports that the proximal end may fail to expand immediately upon deployment and remain connected to the delivery catheter.
Windstone Medical Packaging is recalling Angio Pack surgical kits (Lot 146304 and 147534) due to angio tubing with insufficient or incomplete welds.
Medtronic is recalling 26 tubing packs from its Custom Perfusion System (Lot 221148857) due to potential manufacturing defects. Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots of Medtronic's CB10W65R1 perfusion system tubing packs may have incomplete or insufficient welds that could compromise system integrity during cardiac surgery.
Covidien LP is recalling Electrostatic Filter Angled devices (Item 350S19006) due to potential deviations in ethylene oxide sterilization parameters. These respiratory airway devices for anesthetized patients may not meet required sterility standards.
Medtronic is recalling specific lots of BB11J14R2 Bridge Custom Perfusion System tubing packs due to incomplete or insufficient welds that may have occurred during manufacturing.
Anodyne Surgical has recalled hydrodissection cannulas due to a possible yellowish-brown or greenish-brown residue on the tip. The affected devices were distributed in multiple US states and Canada.
Medtronic is recalling specific lots of HY10Z48R2 Adult ECC Custom Perfusion System tubing packs due to potential weld defects. Affected units may have insufficient or incomplete welds that could compromise device function.
Radiometer Medical ApS is recalling ABL90 FLEX Analyzers with E3800 PC units due to an internal clock issue. Approximately 3,346 units are affected globally, with only 2 in the United States.
The Better-Bladder ECMO device used in cardiopulmonary bypass circuits may collapse during use, increasing venous line resistance and reducing blood flow. The recall affects 147 units distributed nationwide.
Ossur Americas is recalling the MIAMI J SELECT COLLAR cervical spine device due to deforming racks that may reduce immobilization. About 10,469 units were distributed nationwide.
Bard Peripheral Vascular recalls VENOVO Venous Stent System 9F due to reports that the proximal end fails to expand immediately upon deployment and remains connected to the delivery system.
GE Healthcare interventional x-ray imaging systems can develop a display defect that splits and distorts live monitor images into two unequal parts. The defect affects 139 devices with worldwide distribution.
Medtronic has recalled 16 tubing packs from its CB10R79R6 Custom Perfusion System due to insufficient or incomplete welds in specific lots. The defect may compromise device integrity during use.
Medtronic recalls custom perfusion system tubing packs due to potential manufacturing defects in welds. Specific lots may have insufficient or incomplete welds that could affect system integrity.
Medtronic is recalling specific lots of CB7J98R7 Custom Pack perfusion system tubing because some units may have insufficient or incomplete welds. The defect could affect device performance during cardiac surgery.
Medtronic is recalling specific lots of BB10R94R6 Custom Perfusion System tubing packs due to incomplete or insufficient welds. The defect may affect device performance during use.
Medtronic is recalling specific lots of BB8M63R5 adult cardiac perfusion tubing packs due to incomplete welds in the manufacturing process. These defects could compromise tubing integrity during cardiac surgery.
Medtronic is recalling specific lots of BB9G78R8 ECC perfusion system tubing packs due to insufficient or incomplete welds that may compromise device integrity.
Medtronic Perfusion System tubing packs are recalled due to manufacturing defects involving insufficient or incomplete welds in the CB10W63R1 lot. Affected devices may malfunction during use.
Medtronic is recalling perfusion system tubing packs due to manufacturing defects involving incomplete or insufficient welds. No injuries have been reported, but the defect may affect product performance and safety.
Medivators, Inc. recalls 1,381 cases of dialysate concentrate due to a manufacturing anomaly that may result in out-of-specification formulation. Affected lots may not function properly in hemodialysis treatment.
Radiometer Medical ApS recalls E3800 PC Units spare parts due to an internal clock defect affecting analyzers. Approximately 965 units have been distributed worldwide, with 35 in the United States.
Medtronic is recalling specific lots of CB10Y89R10 custom perfusion system tubing packs due to insufficient or incomplete welds. The affected lots were distributed in nine U.S. states.
Medtronic is recalling 18 tubing packs used in perfusion systems due to potentially incomplete or insufficient welds that may compromise device integrity. No injuries have been reported.
Natural Foods Inc is recalling BulkFoods.com brand Basic Vegetable Starter products due to potential Salmonella contamination in the celery ingredient. The recall affects 1lb and 5lb bags and 20lb boxes distributed across 23 US states.
Windstone Medical Packaging is recalling Angio Pack surgical kits containing angio tubing with incomplete or insufficient welds that may fail during use. The recall affects 190 units; no injuries have been reported.
Nissan is recalling certain 2020-2021 Versa, Titan, and Titan XD vehicles because the front turn signal bulbs can crack and fail to illuminate, increasing the risk of crashes.
R.C. Willett is recalling NorthStar 8.5 Arrow U truck campers with specific Dometic stoves because an over-tightened bolt may damage the seal, causing a gas leak and fire risk.
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