689 recalls tagged with “fda regulated”.
Mentor Texas, LP recalled Artoura Breast Tissue Expanders worldwide after discovery of dull infusion needle tips. The issue may make it difficult to advance the infusion set or cause it to break. Patients and healthcare providers should stop using the device immediately and follow manufacturer instructions.
Kirkman recalled 178 bottles of MAXIMUM Zone 1 4% Lidocaine Cream distributed nationwide in the U.S. by Dermal Source. The recall cites stability data that does not support the stated expiry date. Consumers and healthcare providers should stop using this product immediately and contact Kirkman for guidance.
HTO Nevada Inc. dba Kirkman recalled 243 bottles of MAXIMUM ZONE 2, 4% lidocaine cream distributed nationwide by Dermal Source. The recall cites stability data that does not support an expiry date. Consumers and healthcare providers should stop using this product immediately and contact Kirkman for guidance.
Cipla USA recalls 271 cartons of Nilotinib 150 mg capsules nationwide after stability tests show out-of-spec results. The issue affects description and appearance by visual inspection. Stop using and contact Cipla USA or a clinician for guidance.
HTO Nevada Inc. dba Kirkman recalls 27,380 bottles of FIVE-STAR VASOCAINE Spray distributed nationwide by Dermal Source. The recall cites stability data that does not support the product's expiry date. Stop using the spray and contact Kirkman or your healthcare provider for guidance.
Nilotinib capsules manufactured for Cipla USA are recalled nationwide after stability testing showed out-of-spec results. The failure involves description and appearance by visual inspection at six months of long-term stability. Patients and healthcare providers should stop using the product immediately and contact Cipla USA for guidance.
Midodrine Hydrochloride Tablets, 5 mg, 50 tablets in 5 x 10 blister packs, distributed nationwide by Major Pharmaceuticals, are recalled. The packaging defect involves inadequately sealed blister packaging. Healthcare providers and patients should stop using the product immediately and contact The Harvard Drug Group LLC for guidance.
Medline Industries, LP recalled 14,379 anterior hip pack kits distributed nationwide after Olympus biopsy valves showed rubber fragment detachment. The defect can release fragments into the patient’s airway, risking a foreign body in the tracheobronchial tree and prolonging procedures. Stop using the kit and follow recall instructions from Medline and your healthcare provider.
Abiomed recalled 62 Automated Impella Controller units sold to hospitals internationally. The recall warns of a delayed Purge System Blocked alarm display when used with first generation Impella 5.5 pumps. Hospitals should stop using the device immediately and contact Abiomed for instructions.
Medline Industries is recalling 14,379 kits nationwide that include Olympus biopsy valves. The recall follows reports of rubber fragments detaching from the valves during use. Healthcare providers and patients should stop using the affected kits and follow Medline’s recall instructions.
Medline Industries is recalling 14,379 bronchoscopy kits containing Olympus biopsy valves distributed nationwide in the United States. Olympus reports rubber fragments detaching from the valve slit, which could leave a foreign body in a patient’s tracheobronchial tree and may require removal. Hospitals should stop using the affected kits immediately and follow Medline’s recall instructions.
Olympus biopsy valves in Medline Industries, LP thoracic robotic biopsy valve kits are recalled nationwide. The recall covers 14,379 kits distributed across 13 states. Rubber fragments may detach from single-use biopsy valves, creating a risk of a foreign body in the patient’s tracheobronchial tree and possible inflammation or hypoxia. Healthcare providers and patients should stop using the device
Medline Industries, LP recalled 14,379 kits nationwide that include Olympus biopsy valves. The recall concerns rubber fragments detaching in the slit of single-use biopsy valves. Stop using these kits immediately and follow manufacturer instructions for return or replacement.
Medline Industries, LP recalled 14,379 Olympus biopsy valve kits sold nationwide to hospitals and clinics. Olympus biopsy valves in the kits may detach rubber fragments from the valve slit. Hospitals and clinics should stop using the devices immediately and follow the recall instructions.
Merit Medical Systems has issued an active recall affecting 35,591 CentrosFLO Hemodialysis Catheters sold worldwide. The recall centers on a 16F dual-valved splittable sheath introducer that may fail to split as intended. This failure can cause hemorrhage, foreign-body retention, and procedure delays. Healthcare providers should stop using the device and follow Merit Medical's recall instructions.
Merit Medical Systems recalls 368,264 units of the 16F Dual-Valved Splittable Sheath Introducer bulk non-sterile sold worldwide. A design defect may prevent the sheath from splitting as intended, risking hemorrhage and foreign bodies. Healthcare providers should stop using the device and contact Merit Medical for instructions.
Medtronic recalled 453,144 MiniMed 780G insulin pumps worldwide after reports of unintended insulin delivery when the pump height changes relative to the infusion site. The defect stems from gravity-driven pressure changes affecting hydrostatic delivery. Patients and caregivers should stop using the devices immediately and follow the recall notice, contacting Medtronic MiniMed or their clinician’s
Merit Medical Systems recalled 21,591 DuraMax chronic hemodialysis catheters worldwide. The devices use a 16F dual-valved splittable sheath introducer that may not split as intended, risking hemorrhage and procedure delays. Clinicians should stop using the devices immediately and follow the recall instructions.
Medline Industries recalled 651,789 ENFIT G-TUBE connectors (ENFIT1010GC) sold worldwide, including the United States and Canada. The connectors were not manufactured to required dimensional specifications and may not seal properly with ENFit-style devices, which could lead to leakage. Healthcare facilities and patients should stop using this device immediately and follow recall instructions from
Medtronic MiniMed recalled 24,946 MiniMed 740G insulin pumps worldwide after identifying unintended insulin delivery when the pump height changes relative to the infusion site. The defect can cause over-delivery or under-delivery of insulin due to gravity-driven pressure changes. Patients should stop using the device and contact Medtronic MiniMed for instructions on recall steps, refunds or a swap