1,319 recalls tagged with “fda regulated”.
Fresenius Kabi Compounding recalled 1,578 bags of vancomycin HCl injection on February 5, 2026. The company cited a lack of assurance of sterility as the reason for the recall. Healthcare providers and consumers should stop using the product immediately.
Fresenius Kabi Compounding recalled 1,410 bags of ketamine HCl injection on February 5, 2026. The recall stems from a lack of assurance of sterility, posing a high health risk. Healthcare providers and consumers must stop using this product immediately.
Fresenius Kabi Compounding recalled 10,548 bags of thiamine HCl injection on February 5, 2026. The recall follows a lack of assurance of sterility, posing a high health risk. Affected products include several lots expiring between February and May 2026.
Remel, Inc. recalled 97 units of Campy CVA Medium on February 5, 2026. Customers reported low to no recovery of Campylobacter Jejuni ATCC 33291 in the affected lot. Healthcare providers and patients must stop using the product immediately.
GE Medical Systems recalled 125 Imactis CT-Navigation System stereotaxic accessories distributed worldwide to healthcare facilities. The recall cites a potential mismatch between the simulated needle trajectory and the actual trajectory. Healthcare providers should stop using the devices immediately and follow the manufacturer's recall instructions.
Exactech recalled 120 Equinoxe Ergo Modular Impactor Handles after identifying a missing cross-pin. The defect could compromise instrument integrity during surgical use. Hospitals and surgeons should stop using the devices immediately and follow Exactech's recall instructions.
Ion Beam Applications S.A. recalled four PROTEUS 235 proton therapy systems distributed worldwide, including Florida in the United States, and the countries of Italy and Japan. The defect disables the Therapy Safety System's Universal Beam Triggering Interface, so the system may not stop beam delivery if the Healthy Signal from an external gating device is lost. Patients and healthcare providers应该
Exactech recalls 596 Equinoxe Core Instrument Kit units due to a missing cross-pin on the impacter handle. The alert, categorized as a Class II recall, was issued Feb 3, 2026 and remains active. Affected kits were distributed across the United States and in multiple international markets. Stop using the device and follow manufacturer instructions for recall remedies.
Prime Food Processing recalled 79 cases of dried croaker fish on February 3, 2026, due to safety concerns. The uneviscerated fish poses a high risk of food poisoning. Consumers should not consume this product and seek refunds.
B. Braun Medical recalled 105,550 BBraun Medical 21G X4.4CM Winged INF devices worldwide, including Texas and Costa Rica. A dull or blunt needle tip may be difficult to advance or break. Healthcare providers and patients should stop using the device and follow the manufacturer's recall instructions.
B. Braun Medical is recalling 21,000 21GA Winged Infusion Sets (Single Pack) distributed worldwide, including Texas and Costa Rica, catalog 7A3842. The needle tip can be dull or blunt, may be difficult to advance, or break. Clinicians and patients should stop using the device and await manufacturer instructions.
Tandem Diabetes Care recalled 1,380 insulin infusion pumps distributed internationally in the Czech Republic and Slovakia after translation errors in the Czech user guide could cause unintended insulin delivery. The most significant error told users to verify the infusion set is connected to the body when it should be confirming it is not connected. Following this instruction could result in a hyp
Medtronic MiniMed recalled 26,851 MiniMed 780G insulin pumps sold worldwide, including the United States and Israel. Three software defects tied to updates 6.60, 6.61, and 6.62 could misdose insulin. Stop using the affected pumps and follow the recall letter for instructions.
Beckman Coulter Mishima K.K. recalled 47 AU5800 chemistry analyzers sold nationwide in the United States after a software delay can cause calibration and reagent databases to fail to open. The issue occurs when a calibration monitor using Microsoft SQL Server 2022 Express remains open for more than 15 minutes, potentially halting analysis. Healthcare facilities should stop using the devices and (a
Covidien recalled 78 HealthCast Vital Sync Remote Patient Monitoring Systems sold worldwide, including in the United States. Alarms from the bedside monitor may not alarm or transmit to the remote system. Healthcare providers and patients should stop using the device immediately and await recall instructions.
Beckman Coulter Mishima K.K. recalled 142 DxC 700 AU clinical chemistry analyzers nationwide in the United States. The recall cites a software issue that can delay test results. Labs should stop using the device and follow manufacturer instructions for service and remediation.
Medline Industries recalls 2,894 Aqua-Seal Chest Drainage Units from Cardinal Health after updating IFUs to specify adult patients 18 years and older. The devices were distributed worldwide, including California, Chile and Panama. The update clarifies intended patient population and requires action from healthcare providers to stop use until further notice.
ReCor Medical Inc. has issued an active recall for 24 Paradise ultrasound renal denervation catheters distributed nationwide in nine states. The devices were nonconforming and were supposed to be scrapped and not for human use. Healthcare providers and patients should stop using the devices immediately and await manufacturer recall instructions.
Paradise Renal Denervation Catheter was recalled after a single unit distributed nationwide in nine states was deemed nonconforming and not for human use. The device is an ultrasound renal denervation catheter. Healthcare providers should stop using it and contact ReCor Medical for instructions.
Teva Pharmaceuticals recalled 19,056 bottles of Metoprolol Succinate Extended-Release Tablets, 200 mg, sold nationwide. The recall cites failed dissolution specifications, which could affect how the drug releases in the body. Patients should stop using the product and contact Teva or their healthcare provider for guidance.