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
Fresenius recalls 334 2008T BlueStar hemodialysis machines with defective blood pump rotors that may have loose or dislodged guide sheaves after extended clinical use.
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.
A Philips Achieva 3.0T for PET MR diagnostic system (Serial 43006) may have a loose mains distribution unit terminal that could overheat and cause smoke or fire.
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.
Yamaha is recalling certain surface mounter equipment models because they lack required certification labels for laser safety compliance under FDA regulations.
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.
Merit Medical is recalling Prelude Guide Sheath Roadster devices because some sheaths labeled as .018 dilators may actually contain .038 dilators, creating a risk of using incorrectly-sized medical devices.
Mucci Food Products, Ltd. is recalling Tiramisu Italian Dessert due to undeclared milk and incomplete allergen labeling. Consumers with milk allergies are at risk.
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.
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 has recalled 200 SmartPath to dStream MR imaging systems worldwide due to a loose electrical connection in the g-MDU unit that may create a fire hazard in hospital technical rooms.
Philips is recalling its Upgrade dStream MR system due to a potential fire hazard. A loose terminal connection in the g-MDU may create a hotspot causing smoke or fire.
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.
DANONE US LLC is recalling YoCrunch Vanilla Lowfat Yogurt with M&Ms due to undeclared wheat. The product was distributed to one consignee in Florida and poses a risk to consumers with wheat allergies.
Medline 5ML heparin syringes (Model 91867) are being recalled because the syringe sizes and configurations do not match the range of products approved by the FDA. No injuries or illnesses have been reported.
GMAX non-sterile syringes in various sizes and configurations have been recalled because they fall outside the FDA 510(k) scope of the manufacturer's clearance. Affected lots were distributed across six U.S. states.
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.
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.
FUJIFILM is recalling Noblus AC Adapters nationwide due to fire and smoke hazard. The adapters can overheat and generate smoke when the power cable is repeatedly inserted and removed.
The Evolution upgrade 3.0T mains distribution unit is being recalled because its L3 terminal connection may become loose, creating a hotspot that could cause fire or smoke in hospital technical rooms.
Medline non-sterile syringes (Model 91858) are recalled for manufacturing outside FDA-cleared specifications. The recall covers 50,400 units distributed nationwide.
Cadwell Industries is recalling the Cascade IOMAX Cortical Module because an incorrectly installed insulator could cause electrical arcing and potential patient shock.
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.
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.
Fresenius Medical Care is recalling 45,880 Blood Pump Rotors (Model F40015481 Rev A) due to reports of loose or dislodged guide sheaves after use in clinical facilities.
Philips is recalling 139 Ingenia 1.5T S MRI scanners due to a loose terminal connection in the power distribution unit that could create an electrical hotspot and cause smoke or fire. No injuries have been reported.
Philips MRI diagnostic systems are recalled because a loose electrical connection in the g-MDU unit may create a hotspot, potentially causing fire and smoke in hospital technical areas.
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 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.
Preferred Pharmaceuticals is recalling 66 bottles of Duloxetine 30mg capsules (Lot J2022G) due to manufacturing deviations that resulted in N-nitroso-duloxetine impurity above FDA limits.
Philips is recalling Ingenia 1.5T CX Magnetic Resonance systems due to a loose power distribution connection that may create a fire hazard in hospital technical rooms.
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.
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 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.
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.
Philips is recalling 10 MR System 1.5T Marlin MRI devices worldwide due to a fire and smoke hazard. A loose electrical connection in the mains distribution unit may create a hotspot that causes smoke or fire in hospital technical rooms.
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.
Philips is recalling Ingenia Ambition S MRI systems due to a potential fire hazard. A loose terminal connection in the electrical distribution unit may create a hotspot and smoke or fire in hospital technical rooms.
A loose terminal connection in the power distribution unit of Philips Achieva 3.0T TX PET imaging systems may create an electrical hotspot, potentially causing smoke or fire. The device is distributed worldwide.
Jiangsu Shenli Medical is recalling Wolf Medical 60 mL Luer Lock piston syringes because they were manufactured outside the scope of the firm's FDA 510(k) clearance.
Medline non-sterile syringes are recalled because their piston sizes and configurations exceed those approved by the FDA. No injuries have been reported. Approximately 230,800 units were distributed nationwide across six states.
Jiangsu Shenli Medical Production recalled 37,200 GMAX non-sterile syringes manufactured outside FDA-approved specifications. Affected units were distributed across CA, FL, GA, IL, TN, and VA.
Jiangsu Shenli Medical recalled 9,800 GMAX blue syringes because their sizes and configurations fall outside FDA's clearance range. Affected units were distributed nationwide to healthcare facilities and retailers.
Medline 10mL non-sterile syringes have been recalled because their piston size and configuration fall outside the range cleared by FDA. The recall affects 7,000 units distributed nationwide.
Channel Medsystems is recalling the Cerene Cryotherapy Device because error code 003 is missing from the device's troubleshooting documentation, which could prevent clinicians from properly diagnosing errors during use.
Medline non-sterile syringes (Model 91841) are recalled because certain size and configuration variants were not included in the FDA-cleared 510(k) specifications. These uncleared configurations should not have been distributed.
Jiangsu Shenli Medical Production is recalling MEDLINE non-sterile syringes because certain configurations exceed the scope approved by the FDA. The recalled syringes were distributed nationwide across multiple states.
Jiangsu Shenli Medical is recalling 619,200 MEDLINE non-sterile syringes (Model 83087) manufactured in configurations outside FDA-approved specifications. The recall affects units distributed nationwide.
Medline is recalling approximately 95,200 non-sterile 5mL syringes (Model 91825) distributed nationwide because syringe sizes and configurations exceed the scope of FDA 510(k) clearance.
MEDLINE non-sterile syringes (Model 91843) are being recalled because the product's sizes and configurations fall outside the scope of devices approved under the manufacturer's FDA 510(k) submission. The syringes were distributed nationwide across multiple U.S. states.
Medline has recalled approximately 325,500 non-sterile syringes (Model 91831) due to syringe sizes and configurations that fall outside FDA-cleared specifications. The syringes were distributed nationwide and manufactured by Jiangsu Shenli Medical Production Co., Ltd.
American Regent, Inc. is recalling Nicardipine Hydrochloride Injection (25 mg/10 mL) in one lot due to lack of assurance of sterility. The recall affects approximately 4,136 cartons distributed in Utah.
Jiangsu Shenli Medical is recalling 777,400 Wolf Medical 3 mL syringes (Model SYR03L) manufactured outside FDA clearance scope. Users should discontinue use of affected lot codes.
Jiangsu Shenli is recalling GMAX 12ML syringes because the device sizes and configurations exceed what was cleared by FDA. Approximately 303,800 units were distributed nationwide.
Jiangsu Shenli Medical is recalling GMAX SYR 60ML/LS syringes (Model TS2260S-M) because the piston syringe sizes and configurations exceed what was approved by FDA in the company's 510(k) clearance.
Medline non-sterile syringes (Model 91851) are being recalled because their piston sizes and configurations exceed what the FDA approved. Approximately 7,000 units distributed in six states are affected.
Dr. Reddy's Laboratories is recalling Sirolimus 1mg tablets nationwide due to failed impurity and degradation specifications. The recall affects 1,176 bottles from lot H2200493 expiring 6/30/2025.
MEDLINE non-sterile syringes (Model 91859) are being recalled because their sizes and configurations exceed the scope of the manufacturer's FDA 510(k) clearance. No illnesses or injuries have been reported.
Jiangsu Shenli Medical is recalling Wolf Medical 6 mL syringes because certain variants weren't cleared under the 510(k). Approximately 454,400 units distributed nationwide are affected.
Jiangsu Shenli Medical Production is recalling GMAX SYR 10ML Control syringes because the device specifications exceed FDA-cleared limits. Approximately 348,800 units were distributed nationwide.
Sun Pharmaceutical recalls Xelpros latanoprost eye drops (Lot HAD3383A) due to particulate matter contamination detected during release testing. Affected bottles were distributed in Texas and Pennsylvania.
Jiangsu Shenli Medical is recalling 1.59 million GMAX 60ML non-sterile syringes because the syringe sizes and configurations exceed what the FDA cleared the manufacturer to produce. The syringes were distributed nationwide.
Medline non-sterile syringes (Model 83084) are being recalled because they were manufactured in sizes and configurations outside the scope of FDA clearance.
Jiangsu Shenli Medical is recalling 1,117,800 MEDLINE SYR 60ML non-sterile syringes (Model 83080) because certain syringe sizes and configurations exceed what was approved under the manufacturer's FDA 510(k) clearance.
Medline is recalling 820,400 non-sterile syringes (model 91832) because their sizes and configurations fall outside what was cleared by the FDA. The devices were not manufactured within the approved specifications.
Jiangsu Shenli Medical Production recalled 1.7 million MEDLINE piston syringes because the devices' sizes and configurations exceed what was cleared by the FDA. The affected syringes were distributed nationwide across multiple states.
Jiangsu Shenli Medical is recalling Medline 20ML non-sterile syringes (Model 91863) because certain piston syringe sizes and configurations were not cleared under the firm's FDA 510(k). The affected units were distributed nationwide.
Medline's non-sterile syringes (Model 91877) are recalled because their sizes and configurations exceed what was approved under the firm's 510(k) clearance. The regulatory non-compliance affects 3,840 units distributed nationwide.
GMAX non-sterile syringes are being recalled because their actual sizes and configurations exceed the range of specifications the manufacturer obtained FDA clearance for.
Medline is recalling 10ML non-sterile syringes (Model 91857) distributed nationwide because the device configurations fall outside the FDA-cleared range for this product.
MEDLINE non-sterile syringes (Model 91822) are recalled because their sizes and configurations fall outside the FDA-approved range under the manufacturer's 510(k) clearance. Approximately 12,000 units were distributed nationwide.
Medline non-sterile 5mL syringes (model 91829) are recalled because they were manufactured outside the scope of FDA-approved specifications. About 35,000 units are affected.
Jiangsu Shenli Medical is recalling 178,400 non-sterile syringes sold under the Medline brand because the device configurations exceed what was cleared under the firm's FDA 510(k) application.
Jiangsu Shenli Medical is recalling about 38.8 million Medline SYR 10ML L/L non-sterile syringes (Model 83082) because their sizes and configurations exceed FDA-cleared specifications. Nationwide distribution in CA, FL, GA, IL, TN, and VA.
Jiangsu Shenli Medical is recalling 12,600 non-sterile syringes (Model 91855) distributed nationwide. The syringes operate in sizes and configurations not covered by the firm's FDA clearance.
Jiangsu Shenli Medical is recalling 39,200 Medline non-sterile syringes (Model 91850) because the device sizes and configurations exceed the range approved by the FDA's 510(k) clearance. No illnesses or injuries have been reported.
Medline syringes (Model 91845) distributed across six US states are recalled because their piston configurations don't match FDA-cleared design specifications. The recall affects approximately 40,800 units.
Jiangsu Shenli Medical Production is recalling approximately 749,400 non-sterile syringes (10ml) distributed under the Medline brand because their sizes and configurations were not cleared by FDA.
Jiangsu Shenli is recalling Medline 20mL non-sterile syringes (Model 91836, 133,600 units) because certain lot configurations exceed the scope of FDA-cleared specifications. Affected units were distributed across six U.S. states.
Jiangsu Shenli Medical Production Co. is recalling 9,800 Medline non-sterile syringes (Model 91866, Lot 63722070002) because the devices were manufactured in sizes and configurations outside the firm's FDA-cleared scope.
Jiangsu Shenli Medical recalled 18,900 Medline non-sterile syringes (Model 91842) because their sizes and configurations exceed the FDA's approved scope under the firm's 510(k) clearance.
The FDA is recalling GMAX SYR 35ML/LL non-sterile syringes because the device specifications exceed what the manufacturer had FDA clearance to produce. No illnesses have been reported.
Jiangsu Shenli Medical is recalling 12,160 Medline piston non-sterile syringes (Model 91878) because manufacturing sizes and configurations exceed FDA 510(k) clearance scope. Distribution was nationwide via U.S. ports.
HP Hood is recalling Price Chopper Fat Free Cottage Cheese with Pineapple 16oz tubs due to undeclared sugar. Affected products have Item # 54267 and specific production dates in May 2024.
Jiangsu Shenli Medical is recalling Wolf Medical 35 mL syringes because their piston sizes and configurations exceed the range cleared by the FDA 510(k) authorization.
Medline is recalling 10ML syringes in multiple lot codes because the device sizes fall outside the range cleared by the FDA for this product. The affected products were distributed to consumers in six states.
Medline non-sterile syringes (Model 91833) are being recalled because the manufactured syringe sizes and configurations do not match the company's regulatory clearance. Consumers should stop using the recalled lot numbers.
Mercedes-Benz is recalling certain 2023-2025 EQE and EQS models because battery management software may shut down the high-voltage battery, causing a sudden loss of drive power.
Forest River is recalling 854 school buses because the front roof panel may separate in a crash, increasing injury risk.
Tesla is recalling certain 2012-2024 vehicles because the seat belt warning light and audible chime may not activate for an unbelted driver, failing FMVSS 208. A free over-the-air update fixes it.
BYD is recalling 2019-2023 transit buses because an incorrect fuse in the rearview mirror control switch may overheat and increase the risk of a fire.
VinFast is recalling certain 2022-2024 VF8 vehicles because inactive ignitors may have been installed in the airbags, which can prevent them from deploying. 225 units affected.
Ford is recalling certain 2020-2024 Lincoln Aviator vehicles because electromagnetic interference from a cell phone can cause the rearview camera image to flicker or distort.
Mercedes-Benz is recalling 2023 AMG C43 vehicles because incorrectly routed seat wiring may damage the harness, preventing seat air bags from deploying in a crash.
Altec is recalling certain 2020-2024 LR7 and LR8 aerial devices because a hydraulic cylinder feeder tube may become damaged and leak oil, which can result in uncontrolled boom movement.
KME is recalling 2022-2023 Predator fire trucks because an incorrect relay valve may prevent the parking brake from engaging, allowing the vehicle to roll away.
Blue Bird is recalling 2021-2023 Vision school buses because the diesel tank for the fuel-fired heater may leak fuel, creating fire and crash risks.
Rivian is recalling certain 2023-2024 EDV, R1S and R1T vehicles because the headlights may be improperly aimed, failing FMVSS 108. 2,334 units are affected.
Nexxpro is recalling NEXX X.G10 helmets in sizes M and S because they may lack a required carbon layer, failing to provide adequate protection in a crash.
Land Rover is recalling certain 2018-2022 Range Rover Sport vehicles with a Surround Camera System because water may enter the rearview camera, blanking or distorting the image.
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