Archive
616 recalls were announced in May 2024.
Of the 616 recalls this month scored against our rubric, 2% are Critical, 21% are Severe.
Which agencies issued them
Oshkosh is recalling certain Sheppard Steering Gears sold as replacement parts for S-Series vehicles because incorrect assembly may cause the gear to fracture.
Land Rover is recalling certain 2024 Range Rover and Range Rover Sport vehicles because falling transmission oil pressure can cause the clutch to shift into neutral.
Thermo King is recalling certain Tripac-3 Auxiliary Power Units because short mounting bolts may loosen, causing the unit to detach and create a road hazard.
Honda is recalling certain 2018-2020 Fit and 2019-2022 HR-V vehicles, previously covered by recall 23V-046, because the rearview camera image may not display when the engine is started with a key.
Medline is recalling about 1.5 million Bed Assist Bar adult bed rails because users can become entrapped between the rail and mattress, posing a risk of asphyxiation. Two deaths have been reported.
Toyota is recalling certain 2022-2023 Tundra and Lexus LX600 vehicles with V35A engines because manufacturing debris can contaminate the engine and cause main bearing failure, stalling the vehicle.
Vicinity Motor Corporation is recalling 2017 Vi33 and 2022 Vi35 buses because low-pressure CNG hoses may leak, creating a fire or explosion risk.
Autocar is recalling 2023-2024 Xpeditor and Legend vehicles because an improperly secured axle lock nut may allow the wheel end to separate, increasing crash risk.
Compare Brands is recalling ADIOS! Super Vinegar All Natural Cleaner due to deceptive labeling that violates federal hazardous-substances rules, posing risks of poisoning and chemical burns.
About 75 padded crib bumpers sold on AliExpress are being recalled because infants can suffocate if they roll or move into a position that obstructs breathing. Padded crib bumpers are banned under federal law.
Driverge is recalling 2023-2024 Ford T-350 vehicles because the seat recliner mechanism may not engage, increasing injury risk during a crash.
Black & Decker is recalling about 44,400 CRAFTSMAN V20 Cordless Tillers/Cultivators because misleading assembly instructions can cause consumers to attach the tines upside down, creating a laceration hazard. No injuries have been reported.
Hikma Injectables USA Inc is recalling phenylephrine injection syringes that were mislabeled as containing ephedrine. The mix-up creates a serious risk of administering the wrong medication to patients.
Geissler's Supermarket is recalling Shrimp Tempura and Spicy Shrimp sushi rolls due to wheat in the tempura batter that is not declared on the label. Consumers with wheat allergies risk allergic reaction.
BiPAP A40 ventilators may lose therapy delivery during a Ventilator Inoperative alarm, potentially causing respiratory failure or death in vulnerable patients.
Geissler's Supermarket is recalling Pink Lady Salmon & Avo Roll Combo sushi due to undeclared egg allergen. Consumers with egg allergies risk allergic reactions if they consume this product.
Geissler's Supermarket is recalling Spicy Salmon sushi because the product contains egg in mayonnaise but does not declare this allergen on the label. This poses a serious risk to people with egg allergies.
American Furukawa is recalling certain driver clock springs that may have been contaminated during manufacturing. This defect can cause electrical failure and prevent the driver's air bag from deploying.
Geissler's Supermarket is recalling 193 units of Spicy Tuna sushi due to undeclared egg allergen. Products distributed in Connecticut and Massachusetts carry best-by dates of March 27 or 28, 2024.
Philips BiPAP V30 Auto Ventilators may interrupt or lose therapy during a Ventilator Inoperative alarm, potentially causing hypoventilation, severe oxygen depletion, or respiratory failure.
Sammy's Milk Goat Milk Toddler Formula is recalled because the manufacturer made false claims it was safe for infants as a sole nutrition source. The product lacks FDA premarket approval and does not meet infant formula manufacturing standards.
Sammy's Milk goat formula is recalled for marketing it as safe for infants. The unapproved product does not comply with FDA infant formula manufacturing requirements.
Geissler's Supermarket is recalling Shrimp Tempura and Lobster Roll products sold in Connecticut and Massachusetts because they contain undeclared wheat, a common allergen.
OptumHealth Care Solutions LLC is recalling 208 units of the Optum Nimbus II Plus ambulatory infusion pump distributed nationwide due to potential battery failure, system errors, and drug leakage.
Philips OmniLab Advanced + Ventilators may experience an alarm condition that interrupts or stops therapy delivery. This interruption may lead to inadequate breathing support, low oxygen levels, and potentially fatal respiratory failure.
Philips Respironics BiPAP A30 Ventilators may experience interruption or loss of therapy during a Ventilator Inoperative alarm, potentially causing severe respiratory compromise or death in vulnerable patients.
Tama Corporation is recalling Queso de mano (fresh soft white cheese) due to potential Listeria monocytogenes contamination. The affected product was distributed in Utah.
Lion Electric is recalling certain 2024-2025 LionC school buses because the parking brake may malfunction and allow the lever to release without pressing the release button.
MEDLINE non-sterile syringes (Model 91827) are recalled because piston sizes and configurations are outside the FDA clearance range. The manufacturer is recalling 44,800 units distributed in six U.S. states.
Philips is recalling MR RT Upgrades Magnetic Resonance diagnostic systems due to a loose terminal connection in the mains distribution unit that could cause smoke or fire. Two units with serial numbers 70980 and 71569 are affected worldwide.
FDA recalls 60,000 GMAX SYR 5ML/LL non-sterile syringes manufactured by Jiangsu Shenli Medical Production because the piston syringe sizes and configurations were not cleared under the firm's FDA 510(k) application.
Merit Medical Systems is recalling 18 units of Prelude Guide Sheath Roadster due to sheaths labeled as .018 dilators potentially containing .038 dilators instead. The mismatch poses a risk if the wrong-sized component is used during medical procedures.
Grand Design is recalling certain 2023 Solitude fifth wheels because loose or missing fasteners on the refrigerator cooling unit can allow movement that cracks the propane line.
Chuao Chocolatier is voluntarily recalling mini chocolate bars (LOT 4022, Best by 22 FEB 25) due to undeclared hazelnut. The 13,312-bar recall affects distribution broadly across the U.S. and four international locations.
Medline brand non-sterile 5mL syringes (Model 91828) are being recalled because the piston syringe sizes and configurations exceed the manufacturer's FDA 510(k) clearance specifications. The recall affects 22,400 units distributed nationwide.
Philips is recalling 1,585 Achieva 1.5T MR systems worldwide due to a loose g-MDU L3 terminal connection that may create an electrical hotspot causing fire or smoke. No injuries have been reported.
La Original Tortilla Co. is recalling bulk flour tortillas sold to food service due to undeclared wheat allergen. Consumers with wheat allergies should not consume affected products.
Philips is recalling 1,517 Ingenia 3.0T magnetic resonance (MR) systems due to a potentially loose terminal connection in the mains distribution unit that may create a hotspot and cause fire or smoke.
Jiangsu Shenli Medical Production Co., Ltd. is recalling 9,800 Medline non-sterile syringes (model 91852) manufactured in sizes and configurations outside the FDA-cleared range. Customers in six U.S. states should stop using and return the affected product.
Cadwell Industries is recalling the Cascade IOMAX Cortical Module because an incorrectly installed insulator could cause electrical arcing and potential patient shock.
Geissler's Supermarket is recalling Philadelphia Avo or Cucumber Classic Roll sushi due to undeclared milk allergen. Affected products were distributed in Connecticut and Massachusetts with sell-by dates 3/27/2024 and 3/28/2024.
Supreme Tradition and Marcum brand ground cinnamon distributed to US retailers is being recalled due to elevated lead levels. Consumers should not use the affected products.
Medline is recalling 124,800 non-sterile syringes (model 91838) distributed nationwide because their configurations fall outside specifications cleared by the FDA under the firm's 510(k) approval.
Somerset Therapeutics is recalling Haloperidol Decanoate injections nationwide due to the potential presence of trace amounts of water in some vials, which may affect product quality.
Fresenius Medical Care is recalling Blood Pump Rotor components in BlueStar Hemodialysis Machines due to complaints of loose and dislodged guide sheaves during clinical use that could affect equipment function.
Medline is recalling non-sterile syringes with piston sizes and configurations that exceed the FDA-cleared specification range. The affected devices may not function as originally tested and approved.
Medline 10ml syringes in lots 63721060001, 63721110001, 63722120002, and 63723070001 are recalled because their sizes and configurations exceed FDA-approved specifications. No injuries reported.
Philips is recalling 509 Ingenia Ambition X MR systems due to loose terminal connections in the g-MDU L3 unit that may create hotspots and cause smoke or fire in hospital technical rooms.
FDA is recalling approximately 1.64 million GMAX non-sterile syringes manufactured by Jiangsu Shenli Medical because they were sold in configurations not approved by the agency.
Jiangsu Shenli Medical Production Co. is recalling GMAX SYR 60ML/LL blue syringes because the manufactured sizes and configurations fall outside the range cleared by the FDA. Approximately 116,160 units were distributed nationwide.
Navistar is recalling 2024-2025 IC Bus CE school buses because a software error may prevent brake lights from illuminating, increasing crash risk.
Yamaha is recalling certain surface mounter equipment models because they lack required certification labels for laser safety compliance under FDA regulations.
Philips recalls 386 Achieva 3.0T MRI systems due to a loose terminal connection that may create a hotspot and cause smoke or fire in the equipment room.
Jiangsu Shenli Medical is recalling 754,600 non-sterile syringes because the piston syringe sizes and configurations exceed those cleared by the FDA. Affected units were distributed nationwide.
Philips is recalling 200 Intera 1.5T MRI systems worldwide due to loose mains distribution unit connections that may cause electrical hotspots, creating fire and smoke hazards in hospital technical rooms.
Natural Waters of Viti Limited is recalling Fiji Natural Artesian Water 500 mL bottles due to bacterial contamination and manganese found during firm testing. The product was distributed in Washington and nationwide online.
Jiangsu Shenli Medical is recalling 7,000 MEDLINE non-sterile syringes because their sizes and configurations exceed FDA 510(k) approval. The syringes were distributed nationwide and may pose infection risks.
Philips Evolution 1.5T MR systems may have loose g-MDU terminal connections that could create electrical hotspots and cause fires. The recall affects 56 units distributed worldwide.
Medline 3-mL non-sterile syringes are being recalled because their actual sizes and configurations fall outside the FDA-approved range for the manufacturer's 510(k) clearance. 20,000 units were distributed nationwide across six U.S. states.
Philips Ingenia 3.0T CX MRI scanners may experience loose terminal connections in the global Mains Distribution Unit (g-MDU) that could create fire or smoke hazards. The recall affects 350 units distributed worldwide.
Philips is recalling 4 Sonalleve MR HIFU 3.0T diagnostic systems worldwide due to loose electrical connections in the mains distribution unit that may create fire hazards in hospital settings.
Integra LifeSciences is recalling 1,822 units of its Cranial Access Kit due to potential holes and tears in the sterile packaging that may compromise device sterility. The kits are used in ventriculostomy procedures.
American Regent Inc. is recalling Vasopressin Injection nationwide because some vials are subpotent and contain out-of-specification impurities.
Karma Automotive is recalling 2020-2022 Revero models because a communication error may cause front turn signals to fail intermittently, increasing crash risk.
GMAX SYR 20ML/LS non-sterile syringes do not meet FDA-cleared specifications. The recall affects approximately 62,000 units distributed nationwide across 14 lot codes.
Jiangsu Shenli is recalling Medline non-sterile 3mL syringes (Model 91820) nationwide because their configurations exceed FDA clearance scope. Users should discontinue use immediately.
Fresenius recalls 931 BlueStar hemodialysis machines due to loose guide sheaves in blood pump rotors. Facilities should immediately discontinue use of affected units.
The FDA is recalling 98,700 GMAX non-sterile syringes (Model TS2212L-M) because their sizes and configurations exceed FDA-cleared specifications. Affected units were distributed in California, Florida, Georgia, Illinois, Tennessee, and Virginia.
Mucci Food Products, Ltd. is recalling Tiramisu Italian Dessert due to undeclared milk and incomplete allergen labeling. Consumers with milk allergies are at risk.
Siemens Healthcare Diagnostics is recalling certain IMMULITE 2000 Anti-TG Ab test kits due to the potential for falsely elevated thyroid antibody results in patient samples.
Ethicon recalls SURGIFOAM Absorbable Gelatin Powder Kit (Product Code 1979) due to open seals on applicator tips in three lots. The recall affects 5,184 units distributed nationwide.
Medline has recalled SYR 20ML L/L non-sterile piston syringes (Model 83088) manufactured in sizes and configurations outside FDA-cleared specifications. Approximately 13.6 million units were distributed nationwide.
Medline non-sterile 20mL syringes (Model 91835) are being recalled because the piston sizes and configurations do not match FDA-cleared specifications. Approximately 39,200 units are affected.
Jiangsu Shenli Medical is recalling Medline non-sterile syringes (Model 91862, Lot 63722030001) because sizes and configurations exceed FDA-cleared specifications. The recall affects 400 units distributed in California, Florida, Georgia, Illinois, Tennessee, and Virginia.
Philips MR RT imaging systems may have loose electrical connections that could cause smoke or fire in hospital technical rooms. Two units with serial numbers 45 and 47 are affected worldwide.
Philips AchievaXR MR systems may have loose terminal connections in the power distribution unit that could create hotspots and cause smoke or fire. The FDA has recalled 35 affected units worldwide.
Medline is recalling 10mL non-sterile syringes manufactured by Jiangsu Shenli Medical because they were produced outside the range of sizes and configurations approved by the FDA. The affected syringes were distributed nationwide.
Medline 30mL non-sterile syringes (Model 83078) are recalled because their designs fall outside the FDA-cleared specifications. About 4.1 million units distributed in the U.S. are affected.
FoodScience, LLC is recalling Amyloid Complete due to undeclared crustacean shellfish (shrimp and crab). The product poses a health risk to consumers with shellfish allergies.
Aldi macaroni salad products are mislabeled with a coleslaw ingredient statement that does not declare wheat. Consumers with wheat allergies could experience serious allergic reactions if they consume the product.
Philips is recalling Achieva 1.5T MR diagnostic systems worldwide due to a potential loose connection in the mains distribution unit that could create a hotspot and cause smoke or fire in hospital technical rooms.
Wolf Medical 20 mL syringes are recalled because their piston syringe sizes and configurations exceed FDA-approved specifications under the manufacturer's 510(k) clearance. Approximately 378,900 units were distributed nationwide in six states.
Fresenius recalls 334 2008T BlueStar hemodialysis machines with defective blood pump rotors that may have loose or dislodged guide sheaves after extended clinical use.
Wegmans Food Markets is recalling Wegmans Half Loaf Garlic Bread due to undeclared milk. The product may pose a risk to consumers with milk allergies.
Jiangsu Shenli Medical Production Co. recalls approximately 30,800 non-sterile Medline 10mL syringes because their sizes and configurations fall outside FDA-cleared scope. No injuries reported.
Jiangsu Shenli Medical recalled approximately 110,000 MEDIGRATIVE disposable syringes because the manufactured units exceed specifications approved by the FDA.
Medline non-sterile syringes (Model 91876) are being recalled because certain lot codes contain sizes and configurations that exceed the range cleared by the FDA. No injuries or illnesses have been reported.
Medline is recalling 2.1 million non-sterile syringes (Model 83081) because the piston syringe sizes and configurations exceed the FDA 510(k) clearance scope. Affected products were distributed in California, Florida, Georgia, Illinois, Tennessee, and Virginia.
Jiangsu Shenli Medical recalled 3mL non-sterile syringes because they were manufactured outside the scope of FDA approval. The product was distributed nationwide across six U.S. states.
Medline non-sterile syringes (Model 91880) are being recalled because the piston sizes and configurations exceed what the manufacturer submitted for FDA approval. No illnesses or injuries have been reported.
Jiangsu Shenli Medical is recalling non-sterile GMAX syringes for configurations that exceed FDA 510(k) clearance limits. Distributed nationwide, these devices pose infection risk.
Marketside Brioche Rolls may contain undeclared soy lecithin, posing a risk to consumers with soy allergies. Consumers should not eat this product if they have a soy allergy.
Jiangsu Shenli Medical Production is recalling approximately 724,500 Wolf Medical 12 mL syringes because the product configurations exceed the scope of FDA clearance. Units distributed nationwide should be returned.
Philips is recalling the SmartPath to dStream for 3.0T medical device due to a loose electrical connection in the mains distribution unit that may cause smoke or fire in hospital technical rooms. Three units are affected.
Loose terminal connections in the mains distribution unit of Philips MRI systems may create electrical hotspots that could cause smoke or fire. The company is recalling 617 affected units worldwide.
Jiangsu Shenli Medical has recalled over 1 million Wolf Medical WOLF-PAK 1 mL disposable syringes because piston syringe sizes and configurations exceed those cleared under the company's 510(k) approval.
Medline is recalling approximately 525,700 non-sterile 10mL syringes manufactured with sizes and configurations exceeding FDA-approved specifications. No injuries or illnesses have been reported.
Fresenius is recalling 12,292 BlueStar hemodialysis machines because the blood pump rotor component can develop loose or dislodged guide sheaves after clinical use. Patients should contact their healthcare provider to verify if their equipment is affected.
Jiangsu Shenli Medical is recalling 1.248 million GMAX SYR 5ML/LL syringes because the piston sizes and configurations fall outside the range cleared by FDA. The affected non-sterile syringes were distributed nationwide.
GMAX SYR 30ML/LL syringes manufactured by Jiangsu Shenli Medical have been recalled because their sizes and configurations exceed the FDA 510(k) specifications approved for these devices. The recall affects 1,117,500 units distributed nationwide.
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