2,056 recalls tagged with “cpsc regulated”.
Novo Nordisk recalled Wegovy (semaglutide) Injection on December 19, 2025, due to hair found in a prefilled syringe. The recall affects products distributed nationwide in the United States. Consumers should stop using the product immediately and contact their healthcare provider.
Sato Pharmaceutical Co., Ltd. recalled 3,640 bottles of INON ACE Antacid tablets on December 19, 2025. The recall follows failed disintegration specifications, indicating the tablets may not dissolve properly. Consumers should stop using the product immediately and seek guidance from healthcare providers.
Tyber Medical recalled 100 units of its VOLT Wrist Treatment System on December 19, 2025. The recall stems from a manufacturing defect that affects the thread orientation of anatomical left plates. Healthcare providers and patients should stop using the device immediately.
Canon Medical Systems recalled 22 MRI systems on December 19, 2025, due to a potential ice formation hazard in the venting system. The defect could lead to a pressure build-up and helium gas release. Healthcare providers must stop using the affected devices immediately.
Altruan GmbH recalled 188 units of the Clearest Strep-A Cassette Test distributed nationwide in the United States after determining the device was not cleared by the FDA. The test lacks FDA clearance. Healthcare providers and patients should stop using the test immediately and follow the manufacturer’s recall instructions.
Canon Medical System, USA recalled 172 Alphenix INFX-8000C x-ray systems on December 19, 2025, due to loose screws in the ceiling movement gear. This defect can lead to loss of lateral movement, abnormal noise, and sensor errors. Healthcare providers must stop using the device immediately.
Canon Medical System, USA recalled 98 units of its Alphenix INFX-8000F X-ray system on December 19, 2025. Loose fixing screws in the ceiling movement gear may cause malfunction and abnormal noise. Healthcare providers should stop using the system immediately and follow recall instructions.
ICU Medical recalled 64,290 spinal tray syringes on December 19, 2025, due to potential cracks in the syringe collar. The cracks may cause blood leakage and delays in blood draws or fluid delivery. Affected syringes were distributed nationwide across 13 states.
Bisaf Strep A Self-Test from Altruan GmbH remains active in recall status after the FDA flagged lack of clearance. The Class II medical device was distributed nationwide in the United States. The hazard is lack of FDA clearance. Consumers should stop use immediately and follow manufacturer guidance.
Canon Medical Systems recalled 34 MRI systems due to a risk of helium gas release. The recall affects models MRT-3020 and MEXL-3020 distributed across 13 states. Healthcare providers should stop using these devices immediately and follow recall instructions.
Boston Scientific recalled 150 units of its *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System on December 19, 2025. The recall follows increased reports of stent deployment and expansion issues, which could lead to serious medical interventions. Healthcare providers and patients must stop using the device immediately.
Tornier recalled 427 units of its Perform Reversed Perip Screws on December 19, 2025, due to incorrect labeling. The screws, meant to be 5.0mmx18mm, were misidentified as 5.00mmx14mm. This labeling issue can lead to surgical delays or increased risk of mechanical failure if unnoticed.
Novo Nordisk recalled Wegovy (semaglutide) injections on December 19, 2025, after discovering hair in prefilled syringes. The contamination poses a serious hazard to consumers. The recall affects all units distributed nationwide.
Rifton Equipment recalled 3,238 TRAM powered lift devices on December 18, 2025, due to a risk of fraying body support straps. This recall affects models K310 sold worldwide, including the US, Europe, and Australia. Healthcare providers and patients must stop using the devices immediately to prevent injury.
Imprimis NJOF, LLC recalled 596 boxes of intraocular injections on December 18, 2025. The recall affects products due to the presence of glass-like particles. Consumers should stop using the product immediately and contact their healthcare provider.
Rifton Equipment recalled 470 E-Pacer gait training devices on December 18, 2025. The body support strap may fray, posing a risk to users. Health care providers and patients must stop using the device immediately.
HK Brilliant recalled KKL Fabric 9-Drawer Dressers on December 18, 2025, due to serious tip-over hazards. The dressers, sold in black, brown, and white, pose a risk of injury or death to children if not anchored. Consumers must stop using these dressers immediately and return them for a full refund.
CATAO MARKET recalled 3,120 Cuban loaf cakes on December 18, 2025. The recall follows the discovery of undeclared FD&C Yellow #5 in the product. This hazard poses a significant risk for consumers with allergies to this color additive.
Rifton Equipment recalled 1,096 units of the Low Base TRAM on December 18, 2025, due to a potential fraying hazard on the body support strap. The recall affects models distributed worldwide, including the US, Canada, and several countries in Europe and Asia. Patients and healthcare providers are advised to stop using this device immediately.
CATAO MARKET recalled 775 cases of Authentic Cuban Loaf Cake on December 18, 2025. The recall stems from an undeclared color additive, FD&C Yellow #5, which poses a significant health risk. Consumers should not eat the product and should seek a refund or replacement.