1,264 recalls tagged with “fda regulated”.
Philips Medical Systems Nederland B.V. recalled 2 Allura Xper FD10C imaging systems in the United States. The BIOS battery may deplete faster during design, halting startup without warning. Hospitals should stop using the device and follow the manufacturer’s recall instructions.
Philips Medical Systems Nederland recall 115 Allura Xper FD20/20 imaging systems worldwide after reports that the BIOS battery may deplete prematurely. The startup process may halt with no user alert. Hospitals and providers should stop using affected units and await manufacturer instructions.
Inpeco recalled eight FlexLab FLX System Potassium Test System units sold in California and New York. The recall targets the Sample Integrity Module HIL function, which detects hemolysis, icterus and lipemia. The FDA has not evaluated this function for safety or effectiveness, risking erroneous results or delays. Labs should stop using the device immediately.
Philips Medical Systems Nederland B.V. recalls 5,067 Allura Xper FD20 imaging systems worldwide. The BIOS battery may deplete faster than planned, causing the system to fail to start. The issue affects 1,626 US and 3,441 international units. Customers should stop using affected devices and follow manufacturer instructions.
Philips Medical Systems Nederland recalled 2,317 Allura Xper FD10 imaging systems worldwide, including 497 in the United States. The BIOS battery may deplete faster than expected, causing the startup process to halt with no user alerts. Hospitals should stop using the devices and await manufacturer instructions.
Philips Medical Systems Nederland B.V. recalls 313 Allura Centron devices with model 722400 worldwide after a BIOS battery drains too quickly. The issue can halt the system start-up with no user warning. The recall was issued September 3, 2025 and remains active as of October 8, 2025. Consumers should contact Philips or their healthcare provider for instructions.
Philips Medical Systems Nederland B.V. recalls Allura Xper FD20 Biplane OR Table models 722020 and 722025. Four units are affected worldwide, including two in the United States. The BIOS battery may deplete faster than expected, halting the system startup with no user warning. The recall advises stop-use and coordination with healthcare providers for instructions.
Major Pharmaceuticals recalls sulfamethoxazole and trimethoprim 800 mg/160 mg double-strength tablets sold nationwide. A specific lot of packaging coil used in production was found to contain a microorganism in the packaging area, though no microorganism was detected on the tablets. Consumers should stop using the product and follow guidance from Major Pharmaceuticals or their healthcare provider.
A high-risk recall of sulfamethoxazole and trimethoprim 800 mg/160 mg double-strength tablets is active nationwide in the United States. The Harvard Drug Group and distribution partners have halted use of a lot due to a foreign-substance finding in packaging material. No tablets tested positive for micro-organisms. Consumers should stop using the product and consult their healthcare providers.
Canon Medical System, USA recalls 8 SPOT Fluoro digital radiography systems in the United States after a software defect could expose patients to unintended X-ray exposure. The issue occurs when the acquisition program changes and the default ROI causes the collimator and static image to partially cover the collimated area. Stop using the affected devices and follow manufacturer instructions for a
LeMaitre Vascular recalled 28 Artegraft Collagen Vascular Grafts distributed nationwide in 17 states. The grafts use bovine carotid arteries sourced from a supplier not reviewed by the appropriate regulatory authority. Patients and healthcare providers should stop using the device immediately and contact LeMaitre Vascular for instructions.
AvKARE recalled 2,192 cartons of Norgestimate and Ethinyl Estradiol tablets distributed nationwide. The recall cites failed content uniformity specifications. Consumers and healthcare providers should stop using this medicine immediately and contact AvKARE or a healthcare provider for guidance.
ICF Factory recalled 12 pints of Vanilla G. Nutt Ice Cream sold in New York after an undeclared almond allergen was detected. The product may contain almond not listed in ingredients. Consumers should not eat it and contact ICF Factory for refund or replacement information.
BigTree Sales recalled its BT-GERMWAND-LRG-WHT handheld UV-C germicidal wand sold in the United States after FDA enforcement flagged unsafe UVC emissions. The device reaches the exposure limit for Risk Group 3 in about 2.2 minutes, creating a risk of skin and eye injuries. Stop using the device immediately and follow the recall instructions provided by the manufacturer.
Fagron Compounding Services recalls 109,320 sterile single-dose bevacizumab syringes nationwide due to lack of assurance of sterility. Healthcare providers and patients should stop using the product immediately. Contact Fagron Compounding Services or a healthcare provider for guidance. The recall was issued on 2025-08-29 and remains active as of 2025-09-24.
Northeast Scientific Corp. recalled 1,019 units of the NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. The model is not cleared for marketing in the United States. The recall cites potential breaches in sterile barrier packaging that could compromise sterility. Patients and healthcare providers should stop using the device immediately. Follow the manufacturer's recall instructions
Northeast Scientific recalled 141 units of the NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter nationwide in the United States. The device may have breaches in the sterile barrier packaging that could compromise sterility. Hospitals and patients should stop using the device immediately and await instructions from Northeast Scientific Inc. or their clinicians.
Baxter Healthcare recalled 2,304 CLEARLINK System Extension Sets distributed nationwide in the United States. The IV extension set may leak, creating a risk to patients. Stop using the device immediately and follow recall instructions from Baxter or your healthcare provider.
Northeast Scientific recalled 795 NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheters nationwide. The device is not cleared for marketing in the United States. The recall cites breaches in sterile barrier packaging that could compromise sterility. Hospitals and providers should stop using the device immediately and follow manufacturer instructions.
ConvaTec recalled 80,980 DuoDERM Extra Thin wound dressings distributed nationwide in the United States. The dressings may contain foreign matter, which could compromise wound care. Healthcare providers and patients should stop using the dressings and follow recall instructions.