1,882 product recalls found in this category. Browse through all safety alerts and stay informed.
High Activity Category
This category has a significant number of recalls. Please check regularly for updates.
C.R. Bard recalled 4,350 units of the InLay Optima Ureteral Stent Kit on November 6, 2025. The recall was initiated due to a labeling discrepancy where the actual size of the stent may not match its label. This affects distribution across the U.S. and several countries worldwide.
Fresenius Kabi USA, LLC recalls 2,199,850 vials of Famotidine Injection, U.S. distribution nationwide plus Alaska, Hawaii and Puerto Rico after endotoxin testing concerns. The microbial contamination risk prompted an immediate stop-use order. Healthcare providers and patients should follow recall guidance and seek alternatives through their providers.
C.R. Bard Inc recalled 116 units of the InLay Optima Ureteral Stent Kit on November 6, 2025. The recall stems from a labeling discrepancy where the actual stent size may not match the product label. This recall affects distribution in multiple U.S. states and several countries worldwide.
Diasol recalled 2,200 gallons of its 100425-10-DEX100 liquid concentrate for bicarbonate dialysis on November 5, 2025. The company cannot assure the safety and efficacy of the product. Patients and healthcare providers should stop using it immediately.
Diasol recalled 74,400 gallons of its Liquid Concentrate for Bicarbonate Dialysis on November 5, 2025. The recall stems from concerns about the safety and efficacy of the dialysis acid concentrate. Patients and healthcare providers should stop using the product immediately.
Diasol recalled 186,000 containers of its liquid concentrate for bicarbonate dialysis on November 5, 2025. The company cannot assure the safety and efficacy of the product. Patients and healthcare providers should stop using it immediately and follow recall instructions.
Diasol recalled 4,400 gallons of its dialysis liquid concentrate on November 5, 2025. The recall follows concerns that the safety and efficacy of the product cannot be assured. Healthcare providers and patients should stop using the product immediately.
Diasol recalled 4,400 gallons of its 100230-10-DEX100 dialysis acid concentrate on November 5, 2025. The company cannot assure the safety and efficacy of this product. Healthcare providers and patients must stop using the concentrate immediately.
Diasol recalled 7,200 gallons of its 100125-10-DEX100 liquid concentrate on November 5, 2025. The recall affects dialysis patients in multiple states due to unassured safety and efficacy. Patients and healthcare providers must stop using this product immediately.
Cepheid recalled 9,880 units of Xpert MTB/RIF GXMTB/RIF-US-10 after testing failed to meet stability criteria. The devices were distributed nationwide in the United States and Puerto Rico. Health care providers and patients should stop using the device immediately and follow the recall instructions.
Lupin Pharmaceuticals recalled 52,128 bottles of Sertraline Hydrochloride Tablets on November 5, 2025. Consumers reported issues with defective seals that do not adhere to the bottles. The recall follows a Class II classification due to potential contamination risks.
Datascope recalled 47 units of its Cardiosave Rescue Intra-Aortic Balloon Pump on November 4, 2025. The recall addresses a revised Preventative Maintenance schedule in the device's instructions for use. This issue poses a high risk to patient safety and requires immediate attention from healthcare providers.
Datascope recalled 11,470 Intra-Aortic Balloon Pump systems on November 4, 2025. The recall addresses a revision in the Preventative Maintenance schedule as outlined in the Service Manual. Healthcare providers and patients must stop using these devices immediately.
GET TESTED INTERNATIONAL AB recalled 4 MPOX Test devices distributed nationwide in the United States after distribution without premarket approval. The recall cites a regulatory violation rather than an injury risk. Healthcare providers and patients should stop using the device immediately and await instructions from the manufacturer.
GET TESTED INTERNATIONAL AB recalled 19 Allergy Test Small devices distributed nationwide in the United States after distribution without premarket approval or clearance. The devices were distributed without FDA clearance. Patients and healthcare providers should stop using this device immediately and contact GET TESTED INTERNATIONAL AB for instructions.
GET TESTED INTERNATIONAL AB recalled 1,916 Thyroid TSH Tests distributed nationwide in the United States. The devices were distributed without premarket approval or clearance. Healthcare providers and patients should stop using the tests and follow manufacturer instructions immediately.
GET TESTED INTERNATIONAL AB’s Akkermansia Test recall covers 24 units distributed nationwide in the United States. The device was distributed without premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the manufacturer’s recall instructions.
Orthofix U.S. LLC recalled 13,317 PTC Spacer Systems on November 3, 2025, due to inconsistent labeling claims. The recall affects multiple model numbers sold worldwide, including in the U.S. The company advises immediate cessation of use and communication with healthcare providers.
GET TESTED INTERNATIONAL AB recalled 17 DHEA Test devices distributed nationwide in the United States after regulators flagged distribution without premarket approval. The devices lack FDA Premarket Approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the recall instructions.
GET TESTED INTERNATIONAL AB recalled 115 ferritin iron deficiency tests distributed nationwide in the United States. The tests were distributed without FDA premarket approval or clearance. Stop using the device immediately and contact GET TESTED INTERNATIONAL AB or your healthcare provider for instructions.