Archive
649 recalls were announced in November 2023.
Of the 649 recalls this month scored against our rubric, 3% are Critical, 28% are Severe.
Which agencies issued them
Randox Laboratories is recalling the RX Modena-IVD Clinical Chemistry Analyzer nationwide due to parameter re-run settings that may fail to function correctly when samples are outside the assay range, potentially resulting in incorrect test results.
Covidien is recalling McGrath Mac 2 disposable laryngoscope blades due to defective anti-fog coating that can cause condensation and vision obstruction. Approximately 42,367 units were distributed across the United States and internationally.
MicroVention is recalling 14 units of the AZUR CX 35 Peripheral Coil System due to unsealed pouch packaging that could compromise device sterility. The affected units were distributed across eight states.
Randox Laboratories is recalling the RX Daytona Plus (without ISE) IVD Clinical Chemistry Analyzer due to a flaw in rerun settings that may cause incorrect test result reporting.
Nature's Path Organic Dark Chocolate Chip Waffles are recalled because peanuts were not declared on the label, posing a risk to consumers with peanut allergies.
Pepsi Beverages is recalling Crush Orange Soda 24-packs due to plastic foreign material found in some cans. The recall affects 184 cases distributed in Minnesota with lot code JUL2924XXXXMC10243 and a best-by date of July 29, 2024.
Rise Baking Company is recalling Favorite Day Bakery demi French bread sold at Target due to plastic contamination. The affected bread poses a choking hazard and was distributed in California and Iowa.
TUMS Antacid chewable tablets (Assorted Berries, 1000 mg, lot HR5W) are being recalled nationwide because some bottles contain glass mineral wool. Consumers should stop using affected bottles immediately.
GlaxoSmithKline is recalling TUMS Antacid tablets (Lot HB2G) due to glass mineral wool contamination. Affected product was distributed nationwide.
GlaxoSmithKline is recalling TUMS antacid tablets in Lot KH5L due to glass mineral wool contamination. Affected consumers should stop use immediately.
GlaxoSmithKline is recalling TUMS Antacid tablets (Lot HA7G, expiration 8/31/2027) due to contamination with glass mineral wool. The product was distributed nationwide.
Padagis US LLC is recalling Gynazole 1 butoconazole nitrate vaginal cream nationwide due to a manufacturing error where hydrophilic colloidal silica was used instead of hydrophobic colloidal silica.
Sun Pharmaceutical is recalling approximately 2,304 bottles of Liothyronine Sodium Tablets, USP, 25 mcg (lot DNC2204A) due to failed impurity and degradation specifications. The affected medication was distributed nationwide.
GlaxoSmithKline is recalling TUMS Antacid (1000mg Calcium Carbonate) due to the presence of glass mineral wool. The affected lot (HV6B) was distributed nationwide.
GlaxoSmithKline is recalling TUMS Antacid 1000 mg chewable tablets in Assorted Berries flavor due to glass mineral wool contamination found in some bottles. Product was distributed nationwide.
GlaxoSmithKline recalls TUMS Antacid 1000 mg Assorted Berries chewable tablets (lot HR6A) due to presence of glass mineral wool. The product was distributed nationwide.
Nova Biomedical's Stat Profile Prime Plus POC analyzer may report inaccurate creatinine results during the first 2-4 hours after sensor cartridge installation. Standard quality control checks may not detect these errors.
Coapt LLC is recalling the Dome Electrode Gen2 system due to potential burns or blistering from exposure to sunlight, warm temperatures exceeding 12 hours, or battery damage.
Siemens Cios Alpha (VA30) C-arm X-ray systems have a software issue that may not meet updated DIN and IEC standards. This defect could result in patient misdiagnosis or unnecessary repeat imaging.
Randox Laboratories is recalling 13 RX Monaco-IVD Clinical Chemistry Analyzers with a rerun feature defect that may report incorrect test results when samples are outside normal assay range. Units were distributed nationwide including Puerto Rico.
Corin Ltd recalled 3 Unity CR Femur knee implants due to labeling errors. Size 6 implants from batch 529803 may be labeled as size 7, and vice versa.
Cepheid is recalling 1,413 Xpert Xpress Strep A test kits due to a defect in the included pipettes. Defective pipettes may fail to dispense adequate sample volume, resulting in invalid test results or no test result.
Cosmedent is recalling the FlexiCup Composite Finishing & Polishing System due to reports that the elastomer cup material is crumbling. Approximately 7,400 packs distributed worldwide are affected.
Siemens Medical Solutions USA is recalling 367 mobile X-ray systems (186 Cios Flow and 181 Cios Spin) due to a software issue that may result in patient misdiagnosis and repeat radiation exposure. Affected units were distributed nationwide.
Glenmark Pharmaceuticals is recalling Bisoprolol Fumarate and Hydrochlorothiazide Tablets due to failed impurities and degradation specifications. The recall affects 480 bottles distributed nationwide.
Safecor Health recalls Strong Iodine Solution nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The prescription product was distributed in multiple lots across the U.S.
Abbott is recalling 34 NT2000iX radiofrequency generators that were serviced using an out-of-tolerance calibration tool, which may have provided inaccurate measurement results for capacitance failures.
Hillrom Progressa+ hospital beds (499 units) are being recalled due to potential static electricity buildup that could cause mild shock to operators during transport. The affected units were distributed nationwide.
Coapt LLC is recalling 109 ControlSeal Electrodes due to risk of minor burns or blistering if exposed to direct sunlight or warm temperatures exceeding 12 hours, or if the battery is damaged.
Vasoview 6 Pro endoscopic vessel harvesting systems were packaged in incorrect outer boxes displaying artwork for a different device (Vasoview Hemopro 2). The inner labels and product documentation are correct.
Smiths Medical recalls a pediatric tracheostomy tube because the outer box shows an incorrect expiration date (3/17/2021) while the actual product has the correct date (3/17/2026). The discrepancy could cause confusion about product validity.
Edenbridge Pharmaceuticals recalled opium tincture nationwide because the morphine concentration fell below labeled potency. The voluntary recall affected 4,548 bottles.
Medtronic is recalling a small number of LEAD 3387S-40 deep brain stimulation devices due to discrepancies in the Use By Date printed on the outer package versus the individual product label.
Quest Medical is recalling 17,700 Q2 Multiport Extension Sets distributed in the US and Canada. The nature of the defect is not detailed in available source documentation.
Alexis Fire Equipment is recalling 2021-2024 Fire Apparatus vehicles because a defect in the inversion valve may delay parking brake engagement, increasing the risk of unintentional vehicle movement.
Mack Trucks is recalling 2024 MD trucks because the steering wheel attachment bolt may loosen and separate, potentially causing the steering wheel to detach.
Cruise LLC is recalling 950 vehicles because a software defect in the Collision Detection Subsystem may cause the vehicle to move after a crash.
Custom Fire Apparatus is recalling 2021-2024 Spartan emergency vehicles because a parking brake defect may allow unintentional movement, increasing crash risk.
PACCAR is recalling 2024 Peterbilt 520 vehicles because a rear lifting bracket may detach, posing an injury risk during engine lifting.
General Motors recalls certain 2024 Buick Envista vehicles for a software defect that may cause the instrument panel display to go blank, preventing visibility of critical safety information like vehicle speed and warning lights.
Winnebago is recalling 2017-2018 Micro Minnie travel trailers because the murphy bed may raise unintentionally, posing a risk of trapping occupants.
Evenflo is recalling one Titan 65 child seat because it is missing required warning labels, which may increase the risk of injury to the occupant.
Tyson Foods is recalling approximately 29,819 pounds of fully cooked chicken patties that may contain metal pieces. The recall affects specific lot codes distributed to nine states.
Gillig is recalling 2019-2023 Low Floor transit buses because the transmission yoke may separate, causing a sudden loss of drive power and increasing crash risk.
Mercedes-Benz is recalling 2024 GLC 300 vehicles because windows may detach and airbags may lack proper support, increasing crash and injury risks.
Tesla is recalling 2021-2024 Model S and Model X vehicles because an incorrect air bag was installed when the steering wheel was replaced. The incompatible air bag could deploy incorrectly during a crash, increasing the risk of injury.
Gulf Stream is recalling 2024 travel trailers because incorrect tire size and pressure information on the Federal certification label may lead to overinflation and loss of vehicle control.
Forest River is recalling 2023-2024 Sandstorm, Stealth, and 2024 Shockwave travel trailers. The electrical wire from the 50-amp inlet has incorrect gauge and may melt, creating a fire hazard.
Forest River is recalling certain 2018-2024 Coachmen Adrenaline and 2020-2024 Work and Play fifth wheels and travel trailers because side marker lights may not reflect light properly, reducing visibility to other drivers and increasing crash risk.
Fairmont Foods is recalling approximately 147,132 pounds of frozen spaghetti loops with meat sauce due to misbranding and an undeclared egg allergen.
Autocar is recalling 2023 Legend and Xpeditor vehicles because wheel lug nuts may not be tightened properly, increasing the risk of a crash.
Dixon Ticonderoga is recalling Creativity Street Assorted Craft Buttons because they contain lead levels that exceed federal limits. Lead can cause adverse health effects if ingested by young children.
Murf Electric Bikes is recalling about 9,000 electric bicycles sold from July 2017 through April 2022 because they do not meet U.S. safety standards and pose fall and injury hazards. The company has received one report of a fall with minor injury.
Yoocaa baby loungers fail to meet CPSC safety requirements for infant sleep products, posing suffocation, fall, and entrapment risks. About 4,140 units sold on Amazon from January 2021 through May 2023 are affected; no injuries have been reported.
Honda is recalling certain 2023-2024 Pilot vehicles due to a loose ball bearing in the steering rack gearbox assembly. This defect can result in loss of steering control or steering lock-up, increasing crash risk.
Daimler Trucks North America is recalling 2024 Freightliner M2 and 114SD vehicles because an engine lifting bracket may detach, posing an injury risk.
Lochinvar LLC recalls about 17,370 residential condensing boilers sold under three brand names due to cracking flue collectors that can allow carbon monoxide emission. Consumers should contact installers for free repair or ensure working carbon monoxide alarms are installed.
UncleWu Life is recalling approximately 360 infant bath seats sold on Amazon.com from December 2020 through June 2021. The seats fail federal safety requirements and can tip over, posing a drowning hazard to infants.
Grizzly Industrial and Shop Fox wood lathes are being recalled because the cutting tool can break, creating a risk of projectiles striking users or bystanders, and lacerations to users. About 21,300 units are affected.
Cardinal Health is recalling 1,097,048 Monoject 35 mL syringes due to demonstrated compatibility and recognition issues with infusion pumps. The affected units were distributed nationwide.
ResMed recalls Astral ventilators due to a battery fault that can cause sudden power loss. The backup alarm system may fail to alert users due to supercapacitor degradation.
Cardinal Health recalls 3 million Monoject 12 mL Luer-Lock syringes due to demonstrated compatibility issues with syringe infusion pumps that may affect medication delivery.
Cardinal Health is recalling 4.9 million Monoject 20 mL Luer-Lock syringes due to compatibility and recognition issues with infusion pumps. Affected lot numbers from 2022 and 2023 were distributed nationwide.
Cardinal Health recalls approximately 3.1 million Monoject 1 mL Tuberculin Syringes due to demonstrated compatibility and recognition issues with syringe infusion pumps. Nationwide distribution affected.
The Infusomat Large Volume Pump may incorrectly sound an occlusion alarm and stop delivering high-risk medications, potentially causing serious complications.
Cardinal Health is recalling 457,200 Monoject 60 mL Luer-Lock tip syringes due to demonstrated compatibility issues with certain infusion pump systems. The affected syringes may fail to function correctly with these pumps.
Orgain is recalling its Organic Protein & 50 Superfoods Protein Powder with Probiotic (chocolate flavor) due to undeclared sesame allergen. Consumers with sesame allergies are at risk of allergic reaction.
The FDA has recalled ION Sinus Spray due to microbial contamination of the non-sterile product. All lots are affected regardless of expiration date.
Eagle Produce LLC is recalling whole cantaloupe (Kandy brand) in multiple count cartons due to possible Salmonella contamination. The product was distributed to 20 states and Washington D.C.
Toyota is recalling 2013-2018 RAV4 vehicles because certain replacement 12-volt batteries may not fit properly, potentially causing a short circuit and fire.
Kroger brand collard greens packaged in 16oz bags are being recalled due to potential Listeria monocytogenes contamination. Consumers should not consume the affected product.
B. Braun's Infusomat Large Volume Pump battery pack may sound a false occlusion alarm, causing the device to stop pumping. This interruption of high-risk medications can lead to hemodynamic instability and serious medical consequences.
Cardinal Health is recalling Monoject 6 mL Luer-Lock syringes (approximately 3.9 million units) nationwide due to demonstrated recognition and compatibility issues with syringe infusion pumps.
Impedimed's SOZO Bilateral Arm L-Dex Software (versions 4.1 and 5.0) has inadequate sensitivity for detecting early lymphedema, which could delay treatment. The FDA is recalling 354 units distributed nationwide.
GE Healthcare Centricity Universal Viewer software versions 6.0 SP0-SP7.1 may combine radiological images from different patients into a single study, potentially affecting patient care and diagnosis.
Preat Corp is recalling Neodent dental healing abutments (REF 9007124) due to a dimensional condition that may cause gaps between the abutment and implant, potentially allowing microleakage.
Universal Meditech Inc. is recalling the DiagnosUS SARS-CoV-2 Antibody Test because the devices were distributed without marketing authorization and the manufacturer cannot verify manufacturing compliance or post-market safety oversight.
Universal Meditech Inc. is recalling PrestiBio Breast Milk Alcohol Test Strips because the company distributed them without FDA marketing authorization and cannot verify they were manufactured properly. The firm is ceasing operations and cannot fulfill post-market responsibilities.
Universal Meditech Inc. is recalling HealthyWiser UriTest™ UTI Test Strips due to missing documentation of Quality System compliance. The manufacturer is going out of business and cannot fulfill post-market safety obligations.
American Contract Systems is recalling CVS PCSU SJH IV catheter and adhesive components due to improper ethylene oxide sterilization. The components may have reduced functionality or elevated chemical residuals.
Universal Meditech Inc. recalls DiagnosUS hCG Pregnancy Test cassettes distributed in eight U.S. states due to lack of manufacturing documentation and unknown performance characteristics. The firm is going out of business.
American Contract Systems recalled 1260 units of Cath Cardiac Pack due to improper sterilization exposure that may cause loss of functionality or higher ethylene oxide residuals.
Carl Zeiss OPMI LUMERA 300 surgical microscopes may have a missing screw on the suspension arm, potentially allowing suspended components to fall and injure nearby persons. Eight units distributed in Maryland, Texas, California, Georgia, and Louisiana are affected.
Universal Meditech Inc. is recalling diagnostic test strips due to Quality System violations and lack of manufacturing documentation. The company is closing and cannot provide post-market surveillance or support.
Multiple diagnostic test products recalled due to company closure and inability to provide manufacturing and quality control documentation.
Universal Meditech Inc. is recalling 40,000 OMTMO ovulation test strips because the manufacturer is closing operations and cannot provide required manufacturing and quality documentation.
Omega Medical Imaging recalls monitor boom systems where the actuator can separate from the pivot mechanism, allowing the boom to detach. The defect affects units manufactured between October 2012 and July 2019.
American Contract Systems recalled General Pack medical device components (I.V. catheters and adhesive) that were improperly sterilized with ethylene oxide at higher than approved temperatures. The components may lack functionality or have elevated sterilization residuals.
Smith & Nephew is recalling 29 units of a knee prosthesis component due to labeling and packaging errors where two product types were swapped during manufacturing.
Preat Corp is recalling Preat REF 9007121 Neodent GM x 2mm Healing Abutments due to a dimensional condition that may create a gap between the abutment and implant, potentially allowing microleakage. Affected devices were distributed in multiple US states.
American Contract Systems is recalling Pediatric Urology Wolson Packs due to components being exposed to unapproved sterilization processes. Components may have lost functionality or reduced efficacy, potentially compromising device performance.
Medtronic is recalling 77 units of Grafton DBM (Flex) due to a potential failure to perform required inspection of the outer Tyvek sterile pouch. Affected units may not meet sterile packaging standards.
Universal Meditech Inc. is recalling multiple diagnostic test products distributed without FDA authorization or documented quality system compliance. The company is unable to provide manufacturing or post-market surveillance documentation.
American Contract Systems recalls Pediatric Heart SJH components exposed to improper sterilization, risking functionality loss and reduced drug efficacy.
Universal Meditech Inc. is recalling multiple diagnostic test kits distributed without FDA authorization. The firm is closing operations and cannot verify Quality System compliance or provide post-market support.
Universal Meditech is recalling DiagnosUS hCG pregnancy test cassettes distributed without proper FDA authorization and quality documentation. The company is closing and cannot provide manufacturing records or post-market surveillance data.
Diagnostic test strips by Universal Meditech are recalled for unverified performance and manufacturing non-compliance. The firm is going out of business.
FDA is recalling DiagnosUS Ovulation Test Strips from Universal Meditech Inc. because the manufacturer cannot document that the devices were made according to quality standards. The company is ceasing operations and cannot fulfill post-market obligations.
Medtronic Sofamor Danek USA Inc is recalling specific batches of Grafton DBM Orthoblend, an orthopedic implant material, because a required sterile packaging inspection step may not have been performed according to specifications.
Universal Meditech recalled 147,000 pregnancy tests lacking verified FDA clearance and quality documentation. The manufacturer is closing and cannot support post-market safety surveillance.
Looking for a different month? Back to 2023.