Archive
519 recalls were announced in September 2021.
Of the 519 recalls this month scored against our rubric, 1% are Critical, 20% are Severe.
Which agencies issued them
Full Tilt Ice Cream is recalling Salted Caramel ice cream in 16oz pints and 3-gallon tubs distributed in Washington because the ice cream mix did not meet pasteurization specifications.
Pentax Medical is updating reprocessing instructions for certain gastroscope and colonoscope models to ensure proper sterilization. Affected healthcare facilities should review and implement the updated instructions.
Medtronic HVAD Pump Implant Kits may require increased force to remove the driveline cover after strain relief repair, potentially making controller exchanges difficult and risking further repair damage.
BD Alaris needle-free connector valves in Buerette Sets may develop occlusions, difficulty flushing, or flow issues that could delay patient therapy. The product was distributed worldwide across all US states and multiple countries.
Accora Inc is recalling multiple Configura Advance Chair models due to a potential defect where the backrest may detach, creating a fall risk for users.
Rhodes Pharmaceuticals is recalling Oxycodone Hydrochloride 10 mg tablets (Lot # WP5K0Y) distributed nationwide after a foreign Hydrochlorothiazide/Lisinopril tablet was found in one bottle.
Albanese World's Best Mini Gummi Butterflies (7.5oz) contain comingled Olly Sleep dietary supplement that may cause drowsiness. Consumers should not eat the product.
Full Tilt Ice Cream is recalling Backyard Mint Chip ice cream in 16oz pints and 3-gallon tubs because the ice cream mix did not meet pasteurization specifications. The product was distributed in Washington.
Naturo Aid Pharmaceutical Inc. is recalling Vita Aid SynerClear (Chocolate) powder because it may contain undeclared milk residue, which poses a hazard to consumers with milk allergies.
Siemens MR MAGNETOM imaging systems may lose treatment planning data when editing structure sets after reopening a saved study, resulting in incomplete treatment plans being transmitted to planning systems.
BD ADD-ON Burette Set V/NV Needle-Free Valves may experience occlusions or flow issues that could delay therapy. CAREFUSION recalled 44,120 units with this defect.
BD Alaris Pump Infusion Buerette Sets with needle-free connector valves may experience flushing difficulties, flow issues, or occlusions that could delay therapy delivery. No illnesses or injuries have been reported.
Pentax is updating reprocessing instructions for over 28,000 colonoscopes and Upper GI scopes distributed nationwide between 2014 and 2021. Healthcare facilities should implement the updated procedures provided by the manufacturer.
The Lyra Direct SARS-CoV-2 assay can produce false negatives on certain PCR machines when specimens have high viral loads. Revised instructions address this diagnostic failure risk affecting approximately 81,910 kits distributed worldwide.
Cellex is recalling approximately 44,821 units of its qSARS-CoV-2 Antigen Rapid Test due to lack of FDA emergency use authorization. The test was distributed nationwide in California, Florida, Texas, and Wisconsin.
BD Extension Set SMALLBORE Tubing with SmartSite Valves (REF: 20019E) is being recalled due to flushing difficulties, flow issues, and occlusions that could delay therapy. Over 1.4 million units distributed worldwide are affected.
CAREFUSION is recalling BD Gravity Burette Sets with needle-free connector valves that may develop flow restrictions and blockages, potentially delaying medication delivery. Approximately 29,130 units were distributed.
BD Gravity IV needle-free connector valves may develop flow issues and partial or total occlusions that could delay therapy. The recall affects 24,360 units distributed worldwide.
Siemens radiation therapy planning software may lose data when editing treatment structures. Incomplete structure sets could be sent to the treatment planning system, affecting treatment plan accuracy.
Full Tilt Ice Cream, LLC is recalling Coffee Oreo ice cream in 3-gallon tubs distributed in Washington because the ice cream mix did not meet pasteurization specifications.
Full Tilt Ice Cream is recalling Huckleberry Chip ice cream in 3-gallon tubs distributed in Washington because the ice cream mix did not meet pasteurization specifications, posing a food safety risk.
Cypress Medical Products is recalling one case of McKesson Lap Sponges due to a failed sterilization indicator that did not change from red to blue, compromising verification of proper sterilization.
Siemens Medical Solutions USA is recalling 15 ACUSON Juniper Diagnostic Ultrasound Systems worldwide due to intermittent power supply failures that render the devices inoperable. No injuries or illnesses have been reported.
Trader Joe's Raw California Walnut Baking Pieces have been recalled due to mispackaging. Bags labeled as walnut pieces contain a mix of cashews, macadamia nuts, and walnuts.
Four Philips Allura Xper X-ray imaging systems may fail prematurely when powered at 480V hospital mains, causing coil overheating and reduced imaging performance.
Tortilleria Sonora is recalling Roasted Red Pepper 12" Supreme Flour Wraps because the product contains undeclared wheat. The case label lists enriched flour but fails to disclose wheat presence, posing a risk to consumers with wheat allergies.
BD SmartSite needle-free valves may become obstructed, preventing proper fluid flow in medical infusions. The FDA recalls over 295,000 units due to risk of therapy delays.
Philips Allura Xper imaging systems may fail early when supplied with 480V, causing coil overheating and burning smell. When the system fails, X-ray imaging capability is reduced to emergency mode only.
Luminex Corporation is recalling 4,579 Verigene EP Amplification Reagent Kit Test units worldwide due to potential for false positive results. Affected kits distributed across the United States, Austria, France, Greece, Japan, and Turkey may produce incorrect test results.
BD Burette Gravity Set needle-free connector valves may fail to flush or develop blockages, potentially delaying patient therapy. Lot 21015553 consists of approximately 630 units distributed worldwide.
Naturo Aid Pharmaceutical Inc. is recalling Vita Aid SynerClear (Vanilla) powder because it may contain undeclared milk residue. Consumers with milk allergies are at risk.
CAREFUSION is recalling BD SmartSite Bag Access Device needle-free connector valves due to potential occlusions and flow issues that could delay therapy delivery.
Ford and Lincoln are recalling 228,297 vehicles with 360-degree cameras because the rearview camera image may fail to display, reducing rear visibility and increasing crash risk.
Toyota is recalling 2022 Prius and Prius Prime vehicles whose Engine Control Unit software may falsely trigger shutdown of the hybrid system, causing loss of drive power. Contact Toyota at 1-800-331-4331 for a free software update.
Full Tilt Ice Cream, LLC is recalling All The Chocolate ice cream in 3-gallon tubs because the ice cream mix did not meet pasteurization specifications, which may pose a food safety risk.
Full Tilt Ice Cream is recalling Ube ice cream in 3-gallon tubs distributed in Washington because the ice cream mix did not meet pasteurization specifications, which may pose a food safety risk.
Leica Microsystems recalls BOND Ready-To-Use Primary Antibody CDX2 (PA0375, Lot 69909) because the product may not perform as specified in its instructions for use. The recall affects 237 units distributed nationwide.
Meitheal Pharmaceuticals is recalling Glycopyrrolate Injection, USP 4mg per 20mL in 20mL multi-dose vials due to failed impurities and degradation specifications. The recall affects specific lots distributed nationwide in the USA and India.
Akorn, Inc. is recalling Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, due to an unknown impurity found in the product that exceeds specification limits. The affected lots were distributed nationwide.
Vi-Jon, Inc. is recalling Kroger 70% Isopropyl Rubbing Alcohol due to a labeling mix-up. The bottles are labeled as isopropyl alcohol but contain Hydrogen Peroxide 3% instead.
Viatris is recalling Candesartan Cilexetil Tablets, USP 16 mg due to failed impurities and degradation specifications. One lot distributed nationwide does not meet required purity standards.
Workhorse Group is recalling 2020-2021 C1000S, C1000M, and 2020 C650 vehicles because they fail to meet multiple Federal Motor Vehicle Safety Standards, increasing the risk of injury, crash, or fire.
Certain 2019-2021 RAM PROMASTER CITY vehicles may experience turn signal light failures that do not change their flashing rate, preventing drivers from knowing the signals have failed and increasing crash risk. Dealers will update the Body Controller Module software at no cost.
A software error in the radio system of certain 2021 Jeep Grand Cherokee L vehicles may prevent the rearview camera from displaying, reducing rear visibility and increasing crash risk.
Hyundai is recalling 2017 Sonata Hybrid and Tucson vehicles because engine connecting rod bearings may wear prematurely, potentially causing engine damage, fire, or stalling.
DRV Suites is recalling 2021 Mobile Suites and Mobile Suite fifth wheel trailers because improperly tightened brake rotor bolts may loosen or fall off.
Kia is recalling 2015-2017 Sedona vehicles because a software defect may cause turn signals to activate in the opposite direction, increasing crash risk.
Forest River is recalling 2022 Coachmen Aurora travel trailers because they were manufactured with incorrect tire sizes. The wrong tires can become overloaded, increasing the risk of a crash.
Forest River is recalling 2022 East to West Alta travel trailers because a loose LP gas fitting could leak gas, increasing fire risk.
PACCAR is recalling 2020-2021 Peterbilt 520 trucks because a missing rear brake valve may cause incorrect brake release timing, increasing crash risk.
PACCAR is recalling 2022 Peterbilt 567 and 579 vehicles because the Electronic Stability Control malfunction indicator lamp may not illuminate, leaving drivers potentially unaware of ESC failures that could increase crash risk.
Harbor Freight Tools is recalling about 19,000 Bauer Forced Air Propane Portable Heaters because the fitting at the back can fail to be sufficiently tight, causing propane gas leaks and posing a fire hazard. The firm has received 13 reports of gas leaking, including one fire report, with no injuries reported.
Altec is recalling 2016-2021 LS87 aerial devices because bearing bolt washers may interfere with welds, causing bolts to break and increasing injury risk.
Textron Specialized Vehicles recalled approximately 6,600 E-Z-GO PTVs and Tracker Off-Road Vehicles because the parking brake catch bracket can wear out and fail, creating a crash hazard. Consumers should stop using the vehicles immediately.
Vermeer is recalling 2005-2021 McLaughlin and 2021 Vermeer vacuum excavators because rear clearance lamps and reflectors are insufficient, increasing crash risk.
Micro Therapeutics recalls Pipeline Flex Embolization Devices for potential push wire fractures in the delivery system during use. Device fractures in the Hypotube may result in malfunction during vascular procedures.
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. are being recalled due to potential bacterial contamination. The FDA issued a Class I recall on August 18, 2021, advising health care providers to stop using all affected products.
Smiths Medical is recalling NORMOFLO Irrigation Warming sets (Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700) due to potential aluminum leaching when used at lower flow rates with certain solutions and blood products. No illnesses have been reported.
Volvo is recalling 2020-2021 S90, XC60, and XC90 vehicles because a brake component may separate, potentially reducing braking assistance and increasing crash risk.
Micro Therapeutics Inc. is recalling 16,169 EV3 Pipeline Flex Embolization Devices due to potential push wire fractures in the delivery system during use.
Smiths Medical recalls NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129 (913 units) due to potential harmful aluminum leaching when used at lower flow rates with certain solutions and blood products.
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. are being recalled due to the risk of bacterial contamination. Healthcare providers and consumers should stop using affected products.
KBF INC is recalling Banoful Top Orange Biscuit due to undeclared milk. The product poses a hazard to consumers with milk allergies.
The patient tabletop on affected Philips Ingenia Elition MRI systems may not move completely in or out during manual operation, potentially delaying patient evacuation from the device.
Philips Ingenia Elition S-a MRI systems may have tabletop movement failure in manual mode, potentially delaying patient evacuation from the scanner bore and treatment. This affects 64 units distributed worldwide.
Philips Ingenia MRI tabletops may fail to move completely in manual mode, potentially delaying patient evacuation. The recall affects 144 units worldwide.
Mivi Neuroscience is recalling 491 MIVI Super 90 Guide Catheters due to potential nonsterility from a pouch seal defect. The catheters are used to guide microcatheters in vascular procedures.
Siemens Healthcare recalls the Atellica IM BR 27.29 diagnostic test kit because it does not maintain the claimed 10-day calibration interval; the required interval has been shortened to 3 days to ensure accurate results.
Philips infant/child defibrillator pads are recalled due to incorrect labeling that could delay therapy or result in lower energy delivery than indicated.
Certain 2022 Freightliner Cascadia trucks are being recalled because the exhaust pipe outlet may be improperly installed, with the tip facing the battery box. Exhaust heat could melt the battery box, creating a fire risk.
The Philips Ingenia Ambition S-a MRI system may not fully move its patient tabletop in or out of the bore during manual mode operation, potentially delaying patient evacuation and treatment.
Philips MRI systems may fail to move the examination tabletop in manual mode, potentially delaying patient evacuation and medical treatment.
Philips Ingenia Ambition X MRI systems may have tabletops that fail to move completely in manual mode, potentially delaying patient evacuation from the scanner and treatment. The issue affects 147 units distributed worldwide.
Mivi Neuroscience is recalling MIVI Super 90 8F Guide Catheters (investigational sterile devices) due to a potential pouch seal defect that could compromise product sterility.
Philips is recalling 42 Ingenia 1.5T MRI systems because the tabletop may not fully move in or out in manual mode, potentially delaying patient evacuation and treatment.
Philips Ingenia 3.0T MRI systems may fail to move the patient tabletop completely in or out, potentially delaying patient evacuation and treatment. 266 units are affected worldwide.
Ingredion is recalling Fermentation Derived Pepsin due to undeclared egg allergen. The affected product was distributed across multiple U.S. states.
Daimler Trucks North America is recalling 50 model-year 2022 Thomas Built Buses Saf-T-Liner HDX school buses because fan drive pulley assembly bolts may be incorrect or improperly installed, potentially causing a disabled bus.
Trader Joe's Super Spinach Salad packages were prepared using almonds instead of the declared pumpkin seeds, creating an undeclared allergen hazard for consumers with nut allergies.
Olympus recalls Arc Endocuff Vision endoscopic devices for packaging seal defects that may breach sterile barriers, risking patient infection. Approximately 711,157 units nationwide are affected.
Siemens Atellica IM BR 27.29 test kit requires calibration every 3 days instead of the labeled 10-day interval. The product's calibration performance does not meet its Instructions for Use specifications.
Philips Ingenia 1.5T CX-a MRI systems may have a tabletop that fails to fully move in or out during manual operation, potentially delaying patient evacuation and treatment.
Gas One is recalling about 19,500 propane adapter hoses because the hose can swell during use, causing gas to leak and posing a fire hazard. Gas One has received five reports of swelling with no injuries reported.
Ion Beam Applications is recalling certain Proteus 235 proton therapy systems because a misleading popup message may appear when the Oncology Information System disconnects, potentially causing treatment errors.
Nihon Kohden NKV-550 Ventilators with certain serial numbers have a defective gas inlet pressure regulator that could cause malfunction or device check failure. The recall affects 1,999 units distributed globally.
Volvo Bus is recalling 2008-2021 9700 vehicles because headlights may be too bright or dim, failing federal safety standards and increasing crash risk.
Copan Italia is recalling 3,029,400 COPAN FLOQSwabs distributed across the US due to sterilization integrity failures. The clinical sampling swabs cannot be guaranteed sterile due to data integrity issues at the contract sterilizer.
Philips Ingenia 3.0T-a MRI systems have an issue where the tabletop may not completely move in or out during manual operation. This could delay patient evacuation from the scanner bore and postpone medical treatment.
Philips Ingenia 1.5T MRI systems may have a mechanical defect where the tabletop fails to move fully in and out during manual operation, potentially delaying patient evacuation and treatment.
The Instructions for Use for Siemens' Atellica IM BR 27.29 Test Kit incorrectly specified a 10-day calibration interval instead of 3 days. The manufacturer has updated the instructions for all kit lots.
Philips MRI systems (Model 781260) may have a tabletop malfunction in manual mode that prevents complete movement, potentially delaying patient evacuation and treatment.
Angiodynamics is recalling 65 Solero Generator PG devices due to software Error 0001 that can occur during system startup. A software upgrade is required to reduce the incidence of this error.
Angiodynamics is recalling specific refurbished Solero MTA Generators due to Error 0001, which occurs during system startup. A software upgrade is required to reduce the error's frequency.
Charles Paint Research Inc is recalling hand sanitizer products manufactured with acetaldehyde and acetal impurities exceeding allowable limits due to facility contamination issues.
Eight refurbished Solero MTA Generator units require software upgrades to reduce startup errors occurring in specific serial numbers.
Charles Paint Research Inc is recalling 600 gallons of 80% alcohol hand sanitizer distributed in Michigan because the product contains acetaldehyde and acetal above allowable limits.
Native Promotional Products is recalling QiYu Hand Sanitizer 500 mL bottles due to subpotency—the ethyl alcohol content does not meet the labeled 75% (v/v) specification. The voluntary recall affects products distributed to tribal nations in 13 states.
Angiodynamics is servicing specific Solero MTA Generator units to upgrade the software and reduce Error 0001 during startup. Affected units are identified by serial number.
Ford is recalling 2021 Mustang Mach-E vehicles because the windshield may not be properly bonded. This defect could allow the windshield to detach during a crash, increasing injury risk.
Ford is recalling 2021 Mustang Mach-E vehicles because the panoramic roof glass may not be properly bonded, posing a risk of detachment.
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