Medicine, medical device and cosmetics recalls in United States
Recalls of medicines, medical devices, supplements, cosmetics and personal care products published in United States, newest first.
1,518 recalls, newest first · Checked 9 minutes ago
United StatesPhilips North America Llc recalls Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following…
Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to…Acumed LLC recalls Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe…
Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.TMJ Solutions Inc recalls TMJ Bilateral Implants
Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite.GE Medical Systems SCS recalls GE Healthcare AW Server 3.2 ext.6.5
GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext.PFM Medical Inc. recalls Multi-Snare Set: 5 mm x 125 cm
A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the vascular system, failed to meet the biocompatibility requirements…Medline Industries, LP recalls Medline Convenience Kits: 1) DYNJ905503F and 3 more products
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP…Zimmer, Inc. recalls Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ Femoral…
Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.IPG Medical Corporation recalls Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
Software anomaly that causes a false display of error code 5018.Boston Scientific Corporation recalls Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump
There is the potential for leakage along the drug pathway from the pump through the end of the catheter.Intuitive Surgical, Inc. recalls Da Vinci ASSY
Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent…Stryker Neurovascular recalls INZONE DETACHMENT SYSTEM
Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual…Medtronic Perfusion Systems recalls Octopus Evolution Tissue Stabilizer and 2 more products
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned.Philips North America Llc recalls Philips Avalon Fetal Monitor and 1 more products
Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent…Abiomed, Inc. recalls Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product… and 3 more products
Potential for thrombus formation during prolonged use of the introducer.Medline Industries, LP recalls Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes.… and 15 more products
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA.Ventec Life Systems, Inc. recalls VOCSN+Pro package
Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result…Zimmer, Inc. recalls Off-Axis Comprehensive Shoulder System Small and 4 more products
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.Dexcom, Inc. recalls Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US…
Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process.Surgify Medical Oy recalls Surgify Halo and 18 more products
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).Sun Pharmaceutical Industries Inc recalls Perampanel CIII Tablets
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.ANI Pharmaceuticals, Inc. recalls hydrOXYzine Hydrochloride Oral Solution
Presence of foreign substancePReye LLC recalls PReye Vitamin See Antioxidant Preservative Free Eye Drops
Lack of Assurance of SterilityThe Harvard Drug Group LLC recalls Carton Label: MAJOR
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