Archive
412 recalls were announced in July 2021.
Of the 412 recalls this month scored against our rubric, 3% are Critical, 27% are Severe.
Which agencies issued them
GE Healthcare SIGNA Voyager MRI systems may display flipped or incorrectly annotated diagnostic images due to button confusion on the system interface. 541 devices are affected worldwide.
Caribbean Belize LLC is recalling Caribbean Rub spice bottles because they contain undeclared wheat, which poses a risk to consumers with wheat allergies or celiac disease.
Bazzini LLC is recalling Trader Joe's Dark Chocolate Almond Butter Cups (1.4 oz, 2-cup packs) due to potential undeclared peanut allergen. Affected consumers should not consume the product if they have a peanut allergy.
Watson Pickled Garlic Ail Marine (500g pouches) is being recalled because 40 cases containing high lead levels were distributed despite FDA detention.
GE Healthcare recalled 248 units of the Discovery MR750 3.0T scanner due to a button-confusion error where the Patient Orientation button may be clicked instead of Save RX, potentially resulting in incorrectly oriented or flipped images. No injuries reported.
Bea Lydeckers Naturals Inc is recalling Living Free Nerve & Muscle Plus Cetyl-Myristoleate supplement because the label declares lecithin but does not declare that the lecithin is soy-derived, posing a risk to consumers with soy allergies.
Bea Lydeckers Naturals Inc is recalling Living Free "Adult Extra" multi-vitamin capsules because the label declares lecithin but does not declare that it is soy lecithin, posing a risk to consumers with soy allergies.
Limar Hand Sanitizer (70% isopropyl alcohol) in 4 oz bottles is being recalled because the containers resemble drinking water bottles, creating a risk of accidental ingestion.
GE Healthcare recalls SIGNA Premier MRI scanners (100 devices, worldwide distribution) due to a user interface defect where the Patient Orientation button may be inadvertently clicked instead of Save RX, potentially resulting in incorrectly annotated or flipped diagnostic images.
Central hole cover plugs on EcoFit cementless acetabular cups may come loose during surgical implantation, potentially extending operation time or requiring revision surgery. Fifty-one units in Florida and Texas are affected.
GE Healthcare's Discovery MR450 1.5T MRI system may inadvertently change patient orientation when users click the wrong button, resulting in flipped or incorrectly annotated images that could affect diagnostic accuracy.
Canon Medical's Toshiba Vantage Tiitan 1.5T MRI systems are being recalled due to a component that does not meet flame retardancy standards. The defect could result in smoke or fire. Affected units were distributed nationwide.
Canon Medical System is recalling Canon Vantage Galan 3T MRI systems due to a component that does not meet flame retardancy standards, which could result in smoke or fire. The recall affects units distributed nationwide.
GE Healthcare recalls 311 SIGNA Architect MRI scanners due to button confusion that may result in flipped diagnostic images. The 'Patient Orientation' button may be accidentally clicked instead of 'Save RX', causing incorrect image orientation.
Rite Aid is recalling about 9,780 rechargeable handheld fans sold nationwide from April through June 2021 because the lithium ion battery can overheat while charging and pose a fire hazard. The company has received two reports of the fans overheating and emitting smoke, though no injuries have been reported.
GE Healthcare's SIGNA MR355 and MR360 MRI systems are recalled due to a button UI issue that may cause diagnostic images to be flipped or incorrectly annotated. No patient harm has been reported.
Mercedes Medical voluntarily recalled Lingen SAMPLE Virus Sampling Kits due to lack of FDA 510(k) clearance. The recall affects units distributed nationwide and internationally.
Sanit Technologies, LLC is recalling multiple lots of Durisan Antimicrobial Solutions hand sanitizer due to manufacturing deviations. The affected products were manufactured under the same conditions as contaminated lots.
GE Healthcare is recalling the SIGNA MR380 MRI system due to a user interface flaw where the Patient Orientation button may be inadvertently clicked instead of the Save RX button. This can result in incorrectly annotated or flipped MRI images.
Arrow International is recalling its Temporary Pacing Catheter/Introducer Kit (5 units) because it was marketed without FDA 510K clearance. Affected lot numbers: 16F20C0035 and 16F20F0124.
B Force, a homeopathic oral supplement containing multiple active ingredients, is being recalled because it is superpotent. The product was distributed in Florida.
Baxter Healthcare Corporation is recalling 4,752 units of EASYGRIP FLO-41 hemostatic delivery devices due to a discrepancy between the expiration date encoded in the 2D barcode and the human-readable date on the product.
Cipla USA is recalling 7,228 bottles of Solifenacin Succinate Tablets, 10 mg (Lot #GG90819, expiring 06/2021) distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations.
Sanit Technologies, LLC is recalling Durisan Antimicrobial Solutions Hand Sanitizing Wipes (benzalkonium chloride, 0.13%) due to manufacturing deviations that could result in contaminated product.
The Lingen Disposable Virus Sampling Kit by Mercedes Medical was voluntarily recalled due to lacking FDA 510(k) clearance. The recall affected approximately 11,711 boxes distributed nationwide and internationally.
The Harvard Drug Group is recalling Nifedipine Extended-Release Tablets 30 mg due to failed dissolution specification discovered during routine stability testing. The affected lots were distributed in Ohio and New Jersey.
Partner Therapeutics Inc is recalling LEUKINE (sargramostim) for injection due to an out-of-specification result observed at the 27-month stability timepoint. The recall affects 32,260 vials distributed to one government account.
Trail King is recalling 2018-2020 TKOLB trailers because the steering arm may detach, increasing crash risk.
Newmar Corporation is recalling certain 2021 Ventana motorhomes because tie rod clamps may be loose, potentially causing tie rod ends to break or detach and resulting in steering loss.
Daimler Trucks is recalling 267 school buses because the parking brake activation switch may fail to set the parking brake, increasing the risk of unintended vehicle movement and crashes.
Tiffin is recalling 2021-2022 Phaeton and Allegro Bus motorhomes with certain Cummins L9 diesel engines for a potential fuel leak that could cause a fire. The leak occurs between the fuel pump and remote filter head.
Newell Coach Corp. is recalling 2008-2022 P50 vehicles because window vent adhesive may fail, causing the vent to detach and increasing crash risk.
Osage Industries is recalling one 2021 Super Warrior vehicle because the emergency lighting display may lock up, potentially delaying emergency efforts.
ShowHauler is recalling 2018-2020 Garage Coach, Toter Coach, and Motorhome vehicles because window vent adhesive may fail, posing a crash risk.
Certain 2022 Kenworth T680, T880, and W990 trucks have defective HVAC controls that may fail to operate the windshield defrost system, reducing driver visibility and increasing crash risk. PACCAR is replacing the HVAC control heads free of charge.
Mercedes-Benz is recalling 2013 GLK250 diesel vehicles because incorrect transmission parts may cause fluid leaks or module failure, increasing fire and crash risks.
Green Dining Table Inc. is recalling frozen pork dumplings because milk and coconut allergens were not declared on labels, posing potential allergen risks to consumers.
Ford is recalling 2021 F-150 vehicles because brake fluid may leak into the electronic control unit, potentially reducing braking performance and increasing crash risk.
Ford is recalling 2013-2017 Explorers in 23 states and D.C. because road salt exposure can cause rear suspension parts to corrode and fracture, potentially leading to loss of steering control.
Hankook is recalling specific Kinergy GT tires that may separate due to insufficient curative agent, posing a crash risk.
Continental Automotive is recalling specific Hydraulic Electronic MKC1 brake units because a welding deviation may cause the ABS rotor and shaft to separate, potentially reducing braking performance.
Ford is recalling 2020-2021 F-350 Super Duty pickup trucks with 6.7L diesel engines due to rear axle housing that may deform. Driveshaft separation could cause loss of drive power or unexpected vehicle movement, increasing crash risk.
Gillig is recalling 2020-2021 Low Floor vehicles with Cummins L9 Diesel Engines because engine software may allow excessive ammonia into the exhaust, increasing injury risk.
Toyne Inc. is recalling 2020 Spartan MetroStar and Gladiator vehicles because LCD displays may lock up, potentially delaying emergency efforts.
2020–2021 Lincoln Aviators with 3.0L engines may have improperly secured wire harnesses that can contact the A/C compressor pulley, risking electrical damage and fire. Ford will inspect and secure the harness free of charge.
Real Flame is recalling approximately 700 Arroyo and Hideaway wood burning fire pits sold at Crate and Barrel because wood stored under the units can ignite, posing a fire hazard. One incident with minor property damage has been reported.
Magna International is recalling certain Magna Steyr fuel tanks due to improper welding that could cause leaks and increase fire risk.
Teva Pharmaceuticals is recalling Topotecan Injection 4 mg/4mL single-dose vials due to the presence of particulate matter, including glass, silicone, and cotton fiber, found inside affected vials.
Alvogen, Inc. is recalling Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg due to out-of-specification assay results showing low levels of both naloxone and buprenorphine.
Boston Scientific is recalling Accolade pacemaker models L300, L301, L310, L311, L321, and L331 due to latent hydrogen release that compromises the capacitor and accelerates battery depletion.
New Flyer is recalling 28 model-year 2021 XD35 and XD40 buses because engine software may allow excessive ammonia emissions from the tailpipe.
Siemens is recalling Atellica IM 1300 diagnostic analyzer valves due to a manufacturing defect that may cause leaking and affect test result accuracy.
LIEBEL-FLARSHEIM is recalling HydraVision Digital Imaging Systems because the displayed radiation doses are higher than actual delivered doses, potentially affecting clinical decision-making and radiation safety.
Luminex Corporation is recalling 17,110 units of the Verigene Gram Negative Blood Culture test (Model 20-006-021) due to potential false-negative results that may fail to detect Gram-negative bacterial infections.
Boston Scientific VALITUDE CRT-P pacemakers (models U125 and U128) may experience hydrogen release that compromises the capacitor, causing accelerated battery depletion. Patients should consult their healthcare provider.
Boston Scientific is recalling 2,952 Altrua 2 pacemaker units (models S701, S702, S722) distributed worldwide due to hydrogen release that can damage the capacitor and accelerate battery depletion.
Siemens Healthcare is recalling certain ADVIA Chemistry XPT systems with software version 1.4 or lower due to a default mixer failure detection setting that may allow incorrect patient lab results to be reported without alerting clinicians.
Cardinal Health is recalling 13,426 units of Nonsterile Radial/Femoral Angiography Drape (Catalog #29529N) due to a manufacturing defect where plastic film causes the drapes to stick, preventing proper unfolding and application in surgical settings.
A software error in ARTIS angiography systems can cause the C-arm to deviate from intended position by up to 22 cm during imaging procedures. Affected units require identification by serial number.
Luminex Corporation is recalling 1,261 Verigene Clostridium difficile test kits due to potential for false-negative results. The kits may fail to detect C. difficile infections, potentially delaying diagnosis.
Cardinal Health is recalling 3,192 units of Sterile Radial/Femoral Angiography Drapes due to sticking plastic film that may prevent proper unfolding and application during surgical procedures.
Beechnut Nutrition is recalling Beech-Nut brand Single Grain Rice Baby Cereal because certain lots may contain inorganic arsenic above safe levels. Consumers with affected products should stop use and contact the manufacturer.
Vivorte, Inc. is recalling Trabexus EB bone filler due to an incorrect expiration date on product labels. The label shows expiration of 02-15-2019, but the actual expiration is 12-18-2018.
Greenwood Ice Cream is recalling Jersey Cookie Monster Ice Cream because the ingredient statement does not include soy, posing a risk to consumers with soy allergies.
Cardinal Health is recalling 1,638 units of Sterile Cesarean Birth Drapes due to defective plastic film that prevents proper unfolding and application during surgery.
Cardinal Health is recalling Nonsterile Femoral Angiography and Cesarean Birth Drapes (15,360 units) because plastic film causes sticking that may prevent proper unfolding and application.
Randox recalls 50 RX Imola Analyser units nationwide and in Puerto Rico due to software freezing that prevents test results from displaying.
Medtronic is recalling 67,339 CoreValve Evolut PRO Delivery Catheter Systems manufactured before July 11, 2020, due to reports of actuator separation that could affect device function.
Luminex Corporation is recalling 165 units of the Verigene BC-GNv2 diagnostic test worldwide due to the potential for false-negative results in blood culture testing.
Firebird Artisan Mills Gluten Free Organic Brown Rice Flour (50 lb bags, Lot #F21-00198) is recalled due to potential Salmonella contamination. The affected product was distributed to CA, IA, IL, and NY.
Southern Classic Food Group LLC is recalling Milo's Sauce in 5-gallon pails due to undeclared fish allergen. Consumers with fish allergies should not consume the affected product.
Luminex Corporation is recalling 38,990 Verigene Respiratory Pathogens Flex nucleic acid tests due to potential false-negative results. The tests were distributed worldwide, including throughout the United States.
Luminex Corporation is recalling Verigene Enteric Pathogens diagnostic tests due to potential for false-negative results, which could miss serious bacterial infections.
Cardinal Health is recalling sterile femoral angiography drapes because the plastic film causes drapes to stick, which may prevent proper unfolding and application during procedures.
GE Healthcare is recalling Revolution CT systems where a collimator blade malfunction may cause x-ray radiation doses to be delivered in amounts larger or smaller than prescribed.
Medtronic is recalling CoreValve Evolut R Delivery Catheter Systems due to reports of actuator separation. The affected devices, manufactured before July 11, 2020, were distributed globally.
The Binding Site Group is recalling the FREELITE Human Kappa Free Kit due to quality control bias of approximately 10% compared to assigned values. Specific lot numbers distributed worldwide are affected.
Boston Scientific is recalling six Essentio pacemaker models due to a hydrogen release defect that may compromise a critical capacitor and cause accelerated battery depletion. Approximately 31,548 units worldwide are affected.
BioFire Diagnostics is recalling FilmArray Pneumonia Panel test kits globally due to stability failures that increase false negative results between 6 and 12 months of shelf life.
Medtronic is recalling CoreValve Evolut PRO PLUS Delivery Catheter Systems due to reports of actuator separation that could affect proper deployment of these cardiac devices.
Siemens recalls Atellica analyzers (CH 930, IM 1300, IM 1600) due to valve manufacturing defects that may cause leaking and affect clinical test result accuracy.
Boston Scientific has recalled 5,920 VISIONIST CRT-P pacemakers due to hydrogen gas buildup that can compromise a capacitor and cause accelerated battery depletion. Affected patients should contact their healthcare provider for device evaluation.
Luminex Corporation is recalling the Verigene BC-GP blood culture test (Model 20-006-018) due to the potential for false-negative results. Approximately 36,416 units have been distributed worldwide.
Cardinal Health is recalling Cesarean Birth Drapes due to a plastic film defect. The defect causes the drapes to stick, preventing proper unfolding and application during surgery.
Boston Scientific has recalled certain Proponent pacemaker models worldwide. Hydrogen gas may accumulate inside the device, compromising the capacitor and causing accelerated battery depletion.
Cardinal Health is recalling 26,250 units of Nonsterile Femoral Angiography Drapes due to a manufacturing defect causing the drapes to stick and preventing proper application. This may compromise surgical site protection.
Siemens Healthcare Diagnostics has recalled Atellica CH 930 Analyzer valves that may malfunction due to a manufacturing defect. The affected valves may wear and leak over time, potentially impacting diagnostic test accuracy.
BioFire Diagnostics is recalling 3,559 FilmArray Pneumonia Panel plus test kits globally due to stability failures causing increased false negative results between 6 and 12 months after manufacturing, potentially missing pneumonia diagnoses.
Heritage Family Specialty Foods is recalling Taco Casa Green Salsa due to potential foreign material contamination. The affected product was distributed nationwide.
Academy Sports + Outdoors is recalling about 3,860 Ozone 500 Girls' and Boys' Elevate 24-Inch Bicycles because the rear shock spring can become stuck, creating a pinch point and posing a fall hazard to riders.
Walgreens is recalling about 54,000 Disney Baby Winnie the Pooh Rattle Sets because the feet can detach and pose a choking hazard to young children. Consumers should immediately remove the rattle from children and contact Walgreens for a refund.
The GE Healthcare Revolution CT system's user interface fails to update and confirm when scan group names are added using certain characters. This configuration defect requires a software fix to ensure proper scan group setup.
Sentinel CH SpA is recalling ACE Control Set diagnostic control kits due to stability claims after reconstitution that do not meet specified requirements. Updated handling instructions have been provided to affected users.
Cardinal Health is recalling 574 units of Sterile Femoral Angiography Drapes because the plastic film causes the drapes to stick, preventing proper unfolding and application during surgery.
Genentech is recalling two lots of Xolair (omalizumab) injection nationwide due to out-of-specification Polysorbate 20 content detected at the 12-month stability testing timepoint. The affected lots are 3352758 and 3352759, both with August 2021 expiration dates.
The GE Revolution CT user interface may fail to confirm when scan group names are added if they contain characters other than letters, numbers, or spaces.
The GE Revolution CT imaging system's user interface fails to update and confirm when scan group names contain characters other than letters, numbers, or spaces, potentially causing user uncertainty during scan setup.
Heritage Family Specialty Foods, Inc. is recalling Hatch Verde Salsa Medium (12 oz jars) due to potential foreign material contamination. The recall affects 646 cases distributed nationwide.
Yakult U.S.A. Inc. is recalling Yakult Nonfat Probiotic Drink (2.7 FL. OZ. bottles) because testing found trace levels of yeast and the presence of Candida pelliculosa in the product.
Fresenius Kabi USA LLC is recalling Xylocaine-MPF with Epinephrine 1:200,000 injection vials nationwide due to low out-of-specification results for epinephrine assay.
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