Archive
601 recalls were announced in October 2024.
Of the 601 recalls this month scored against our rubric, 1% are Critical, 15% are Severe.
Which agencies issued them
Ossur is recalling Miami J Select Collars due to pressure-sensitive adhesive hooks that may peel off during repeated use, potentially reducing cervical spine immobilization effectiveness.
Siemens Healthcare Diagnostics is recalling 9783 kits of the Atellica IM aTPO Assay diagnostic test due to positive bias in patient results below the 60 U/mL cut-off level, which may produce inaccurate test results.
A carbamazepine (anticonvulsant) tablet was found in bottles of atorvastatin (cholesterol medication). The affected lot includes 2,328 bottles distributed nationwide.
Grace Imports is recalling KARA BOONDHI due to undeclared wheat allergen on the label. The affected product was distributed to retail stores in Georgia.
Kent Precision Foods Group is recalling Sqwincher Electrolyte Beverage Mix (Orange powder, lot 2B0165712) due to potential metal contamination. The product was distributed in 11 states.
A component in certain Tablo Hemodialysis consoles may fail to detect small blood leaks promptly, potentially causing symptoms like hypotension, fatigue, and dizziness if undetected blood loss occurs.
DVOT antigen test kits lack FDA authorization for US sale. Approximately 50,000 unauthorized kits were distributed. Users should discontinue use immediately due to unvalidated safety and accuracy.
Advanced Accelerator Applications is recalling 99 doses of Pluvicto (lutetium LU-177 injection) due to manufacturing quality deviations. The affected lots were distributed to six states.
Philips DIVA 24-inch touch display may generate unintended touch inputs, risking erroneous acknowledgement of patient alarms and delayed detection of patient condition changes. No injuries have been reported.
Heart of the Earth ceremonial cacao paste is being recalled due to elevated lead levels in the product. Consumers should not consume this product and should contact a healthcare provider if they have concerns.
Grace Imports is recalling Spicy Murukku snack due to undeclared wheat on the label. Consumers with wheat allergies face serious health risks from unlabeled exposure.
The Posh Bakery is recalling Whole Grains chocolate chip muffins due to undeclared milk and wheat allergens with missing allergen labeling. Those with milk or wheat allergies should not consume this product.
The Posh Bakery is recalling Carrot Muffins due to undeclared whey (milk), wheat flour, and coconut allergens, plus missing nutrition facts and allergen labeling. Consumers with allergies should not consume this product.
Big Bottom Milk Company is recalling chocolate milk that was not properly pasteurized. The recall affects 251 units distributed to Georgia, North Carolina, and South Carolina.
The Posh Bakery is recalling 6-ounce Poppy Seed Muffins due to undeclared milk (whey), wheat, and almond allergens. The product lacks required allergen labeling, posing a risk to consumers with allergies.
Kent Precision Foods Group is recalling Sqwincher Electrolyte Beverage Mix in four flavors due to potential metal contamination. The affected powdered beverages were distributed across 11 states.
The Posh Bakery recalls Whole Grains Bakery Banana Nut Muffins (6 oz) due to undeclared milk and wheat allergens. The muffins lack required allergen-contains statements and nutritional fact labels.
Big Bottom Milk Company is recalling 701 units of Chocolate Milk Grade A (1-pint bottles) distributed in Georgia, North Carolina, and South Carolina due to failure to achieve required pasteurization temperatures.
Young Dental Manufacturing is recalling BIOTROL PURIT Clean-It Ultrasonic Cleaner (REF PC016) due to bacterial contamination in the bulk product used for repackaging. The recall affects 1,391 units distributed across 10 states.
Mini Raspberry Lemon Coffee Cake products in Washington were mislabeled and contain undeclared walnuts and wheat. Consumers with allergies to these ingredients should not consume the product and should return it to the store.
Blue Tape Sriracha sauce (136 bottles, 10.5 oz each) was manufactured without the required authorization for producing acidified foods, creating potential safety risks.
Healgen Scientific is recalling 1,636,994 urinalysis test strips in California, Georgia, and Texas due to reduced protein detection sensitivity that may produce false negative results and delay kidney disease diagnosis.
Grace Imports recalled Kerala Mixture snack due to undeclared wheat allergen. The supplier failed to disclose wheat on the product label, posing a risk to consumers with wheat allergies.
The Posh Bakery is recalling Cranberry Muffins due to undeclared whey (milk) and wheat flour, as well as missing nutrition facts panel and allergen statement. Consumers with milk or wheat allergies should not consume these products.
The DVOT SARS-CoV-2 Antigen Test Kit (Model FCY-AGT-01) manufactured by Feng Chun Yuan Medical Equipment has been recalled from the U.S. market because it was not authorized for sale in the United States.
The DVOT SARS-CoV-2 & Influenza A+B Antigen Combo Test Kit (Model FAT01) has not obtained FDA authorization for sale in the United States. All lots distributed in the U.S. are subject to recall.
Ryaltris nasal spray is being recalled because the dip tube is clogged, preventing the spray from functioning. The recall affects 45,504 bottles distributed nationwide.
Glenmark Pharmaceuticals is recalling Ciclopirox Gel 0.77% tubes nationwide due to broken seals. The recall affects 11,568 tubes; no illnesses or injuries have been reported.
Pirelli is recalling specific Scorpion Trail II and Metzeler tires because irregular wear may break the belt reinforcement, causing tread separation and increasing crash risk.
USDA FSIS issued a public health alert for Hans Kissle Cranberry Chicken Salad products that may contain undeclared wheat. Consumers with wheat allergies should not consume the product.
Quality Van is recalling one 2023 Ford Transit 350 because the seat recliner mechanism may not engage, increasing injury risk in a crash.
Forest River is recalling 2025 Catalina CAT243RBSLE travel trailers because the Federal Placard label lists an incorrect Gross Axle Weight Rating, which could lead to vehicle overloading.
Winnebago Industries is recalling 2025 Navion and View motorhomes because a screw may damage the seat belt retractor. A damaged retractor may not secure occupants properly, increasing the risk of crash-related injury.
Terex is recalling 2023-2024 TL and TM series vehicles because a weak weld on the jib extension hydraulic cylinder rod may fail, increasing injury risk.
Honda is recalling certain 2023 CR-V Hybrid vehicles due to incorrectly manufactured high-voltage battery modules that may break and spark, creating risks of fire and loss of drive power.
Altec is recalling 2024 AT200A aerial trucks because inadequate clearance between hydraulic hoses and the engine exhaust manifold may cause overheating and increase fire risk.
Honda is recalling 1,693,199 vehicles across multiple model years due to a steering gearbox assembly manufacturing defect that can cause difficulty steering. Dealers will replace the component free of charge.
A software error may cause the rearview camera to display a blank screen in 2025 Nissan Rogue and related vehicles while in reverse, reducing driver visibility and increasing crash risk.
Volvo is recalling certain 2022-2024 VN trucks for a defect in the electronic control unit that can cause unintended acceleration. When the vehicle's communications system is interrupted, this may result in sudden acceleration increasing crash risk.
A software error may cause the rearview camera in 2025 INFINITI QX80 vehicles to freeze and display a blank screen when in reverse, reducing rear visibility and increasing crash risk. Dealers will reprogram the AVM software free of charge.
Smiths Medical is recalling paraPAC Plus 310 ventilators because the patient outlet connector may loosen or detach, potentially interrupting ventilation. Approximately 11,244 units worldwide are affected.
Datascope Corp. is issuing a software correction for CARDIOSAVE RESCUE intra-aortic balloon pump devices to address risks of hemodynamic instability and failure to properly transmit clinical data worldwide.
Datascope's Cardiosave Hybrid IABP devices carry a risk of hemodynamic instability and clinical data transmission failure due to a software defect. Datascope has developed a software correction (Revision D.00) to mitigate this risk.
Datascope Corp. is recalling the CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP globally due to software defects risking hemodynamic instability and clinical data transmission failure.
General Motors is recalling certain 2024-2025 Chevrolet Silverado HD trucks because the air bag module may not have been activated, preventing deployment in a crash.
Boston Scientific is recalling Agile Esophageal Over the Wire Stent Systems because the delivery catheter tip may detach. The recall affects 19 units distributed worldwide.
Navistar is recalling 2024-2025 IC Bus school buses because brake caliper mounting bolts may not be properly tightened, allowing the brake caliper to detach and cause loss of braking ability. Owner notification was sent in November 2024.
BMW is recalling certain 2024 i7 M70 and related models because the integrated brake module may malfunction, potentially reducing braking power and vehicle control. Dealers will replace the module at no cost.
Boston Scientific is recalling Agile Esophageal Stent Systems because the delivery catheter tip may detach. The recall affects 17 units distributed worldwide.
Datascope CARDIOSAVE Rescue IABP devices have a software defect that risks hemodynamic instability and clinical data transmission failure. A software correction is available.
Fresenius Kabi is recalling Ivenix Infusion System software (Version 5.9.1 and prior) due to anomalies that can cause pump malfunctions, alarms, or unresponsive screens while delivering medication, risking serious patient harm.
Smiths Medical is recalling 3,182 paraPAC 300 ventilator kits because the patient outlet connector may loosen or detach, impacting active ventilation.
Centinel Spine is recalling the Prodisc C SK cervical disc replacement due to blue discoloration on the inlay observed during assembly. This discoloration is a foreign contaminant that was not fully evaluated in manufacturing validations.
The Ingenia Elition X MRI device may have loose screws that interfere with the horizontal tabletop, potentially delaying patient diagnosis and causing anxiety during extended bore exposure.
American Contract Systems is recalling 60 Shoulder SESH18I medical convenience kits nationwide due to equipment failure that resulted in out-of-specification humidity readings, preventing sterilization assurance confirmation.
American Contract Systems is recalling the Essentia MAJ Laparotomy Std Pack because an equipment failure prevented confirmation of sterilization requirements for this medical convenience kit.
Boston Scientific is recalling Wallflex and Agile esophageal stent systems worldwide due to the potential for delivery catheter tip detachment during placement. The recall affects 133 units distributed globally.
TMJ Solutions Inc is recalling the Stryker TMJ Unilateral Implant because patient-fitted prostheses contained incorrect components. Patients should contact their healthcare provider immediately.
Philips recalls certain Ingenia 1.5T MRI devices due to loose assembly screws that may block the patient tabletop, potentially delaying diagnosis and causing patient anxiety.
Boston Scientific is recalling WallFlex and Agile esophageal stent systems due to potential delivery catheter tip detachment during stent placement procedures.
Philips recalls Evolution Upgrade 3.0T MRI devices due to loose screws that may block the tabletop and delay diagnosis. Devices with the affected serial numbers should be taken out of service.
Boston Scientific is recalling Wallflex and Agile Esophageal Stent Systems due to potential for delivery catheter tip detachment. The recall involves 124 units distributed worldwide.
Boston Scientific recalls WallFlex and Agile esophageal stent systems (305 units) due to potential delivery catheter tip detachment. Affected products were distributed worldwide.
The BD Phoenix 100 system may misidentify Escherichia coli in clinical samples, potentially leading to misdiagnosis and inappropriate patient treatment. Becton Dickinson is recalling 764 units distributed worldwide.
Boston Scientific has recalled 308 units of WallFlex and Agile esophageal stent systems due to the potential for delivery catheter tip detachment during stent placement. The affected devices are distributed worldwide.
Boston Scientific is recalling Wallflex Esophageal Stent Systems due to potential delivery catheter tip detachment that could affect proper stent deployment during medical procedures.
Bard Peripheral Vascular is recalling BARD MAGNUM Disposable Core Tissue Biopsy Needles due to possible packaging damage from manufacturing that may compromise sterility.
Roche Diagnostics is recalling Creatine Kinase test reagents that may exhibit abnormal calibrations, producing inaccurate results. Lot 755471 distributed nationwide.
Philips is recalling 7 MR 7700 MRI scanners because loose screws may block the tabletop, potentially delaying diagnosis or causing patient anxiety.
Philips SmartPath to dStream 1.5T MRI devices may have loose assembly screws that could block the diagnostic tabletop and delay imaging. 32 units distributed worldwide.
Skagit River Bakery & Cafe is recalling approximately 1,200 units of bulk blueberry scones distributed in Washington because the labels fail to disclose soy lecithin and soybean oil. Consumers with soy allergies may be at risk.
Cook Biotech is recalling 35 units of Biodesign Fistula Plug surgical implants that expire before their printed expiration dates, potentially compromising device function.
American Contract Systems recalls IR Procedure Pack (Lot 2405102, expiration 05/10/2024) because it cannot confirm sterilization requirements were met. An inoperable chart recorder caused humidity levels to be out-of-specification.
Cook Biotech is recalling 8 units of Biodesign Recto-Vaginal Fistula Plug devices because they expire before the date printed on the label. The affected products may lose sterility if used after actual expiration.
Fisher & Paykel's Airvo 3 respiratory device has a software defect that may cause it to deliver only room air instead of oxygen during certain alarm conditions, potentially causing oxygen desaturation and hypoxia in patients.
Infla-650 Herbal Dietary Supplement is being recalled because it contains undeclared acetaminophen, diclofenac, and phenylbutazone. The product was marketed without FDA approval and poses a risk of drug interactions and adverse effects.
Boston Scientific is recalling Wallflex and Agile esophageal stent systems due to potential detachment of the delivery catheter tip during stent placement. These devices are used to maintain patency in esophageal strictures caused by malignant tumors or esophageal fistulas.
Cardinal Health is recalling Salem Sump Dual Lumen Stomach Tubes because the Anti-Reflux Valve may break due to improper use. Labeling changes were made to address the issue.
Allergen is recalling specific lots of Refresh LACRI-LUBE eye ointment (763,426 tubes) due to potential breaches in the tube seal that may compromise sterility. Consumers should verify their product lot number against the recall list.
Karl Storz Endoscopy is recalling 5 nephroscopes because their instructions for use list reprocessing methods not reviewed or approved by the FDA.
Boston Scientific is recalling Agile Esophageal Stent Systems because the delivery catheter tip may detach. The recall affects 10 units distributed worldwide.
American Contract Systems is recalling 93 units of Endovascular AAA Packs due to inability to confirm sterilization assurance requirements were met following an environmental monitoring failure.
Ascend Laboratories recalled 117,493 bottles of Mycophenolic Acid tablets nationwide because the tablets failed to meet dissolution specifications. Patients taking this medication should consult their doctor.
McKesson Medical-Surgical is recalling 27 bottles of Proparacaine Hydrochloride ophthalmic solution (lots 476261, 479751, 479741) due to temperature abuse that may have compromised sterility. Product was distributed to medical facilities in Maryland and Virginia.
Custodiol HTK Solution is subject to a Class II recall due to the potential for particles in the solution. The affected product consists of 48 cartons distributed in North Carolina.
Boston Scientific is recalling WallFlex and Agile esophageal stent systems due to potential for delivery catheter tip detachment during insertion.
The BD Phoenix M50 instruments may misidentify Escherichia coli (E. coli) in clinical samples, potentially causing misdiagnosis and inappropriate treatment. About 4,295 affected units were distributed worldwide.
Ultrasonic cleaner solutions contaminated with pathogenic bacteria may cause serious infections if used in medical or dental procedures, and may leak or become bloated. Patients and healthcare workers handling the products are at risk.
AbbVie is recalling Refresh P.M. lubricant eye ointment due to potential breaches in tube seals that may compromise product sterility. Approximately 2.4 million tubes were distributed nationwide and internationally.
Siemens ACUSON Maple ultrasound systems may perform incorrect unit conversion in software, producing values 10 times smaller than actual. This could lead to misdiagnosis or inappropriate patient management.
Karl Storz Hopkins Telescope 6 endoscopes are recalled because their Instructions for Use contain reprocessing methods that lack FDA review and approval.
Karl Storz Hopkins Telescope 6 endoscopes (59 units, nationwide) are recalled because their reprocessing instructions lack FDA review and approval for safety and efficacy.
American Contract Systems is recalling 48 Arthroscopy Packs because humidity readings were out of specification, preventing confirmation of sterilization.
American Contract Systems is recalling the PACEMAKER PACK (Lot 2405112) due to an inoperable chart recorder that prevented confirmation of sterilization requirements. Affected units were distributed in MO, MN, MA, OH, and NE.
Boston Scientific is recalling WallFlex and Agile esophageal stent systems due to potential delivery catheter tip detachment. The recall affects 79 units distributed worldwide.
Philips Ingenia Elition S MRI machines (10 units) are recalled because assembly screws may come loose and interfere with the horizontal tabletop, potentially delaying diagnosis and causing patient anxiety.
American Contract Systems, Inc. is recalling the Vaginal Delivery ASDV25B medical convenience kit due to an inoperable chart recorder that prevented confirmation of sterilization assurance. The device may not meet required sterilization standards.
Cook Biotech is recalling 130 units of Biodesign Fistula Plug C-FPS-0.7-2 surgical implants because the devices expire prior to the expiration date printed on the labeling. Devices were distributed worldwide including the US and 11 other countries.
American Contract Systems is recalling 3 units of the COPM11B pacemaker medical kits due to inability to confirm sterilization requirements were met. An inoperable chart recorder caused humidity readings to exceed specifications during manufacturing.
Boston Scientific recalls WallFlex and Agile Esophageal Stent Systems due to potential delivery catheter tip detachment. The affected stents treat esophageal strictures and may cause procedural complications if detachment occurs.
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