The latest headlines across every section, pulled from official and open-access sources.
Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint. — Golden State Medical Supply Inc. · Class II · Ongoing · 2,961 bottles
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent. — INSPIREMD Inc · Class II · Ongoing
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON. — GE Medical Systems, LLC · Class II · Ongoing
There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect GTIN labeling is used as the singular source for product identification, unrecognized use of a potass… — Fresenius Medical Care Holdings, Inc. · Class II · Ongoing
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. — Avanos Medical, Inc. · Class II · Ongoing
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. — Avanos Medical, Inc. · Class II · Ongoing
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. — Avanos Medical, Inc. · Class II · Ongoing
The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays. — Mozarc Medical US LLC · Class II · Ongoing
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. — Avanos Medical, Inc. · Class II · Ongoing
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. — Avanos Medical, Inc. · Class II · Ongoing
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. — Avanos Medical, Inc. · Class II · Ongoing
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent. — INSPIREMD Inc · Class II · Ongoing
Reusable electrodes may not meet expected performance levels. — Boston Scientific Neuromodulation Corporation · Class II · Ongoing
Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label. — In2bones USA, LLC · Class II · Ongoing
Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acquired from two or four different amplifiers used in a multiple amplifier configuration (128 or 256 channels) running firmware version 2022.02 were displayed with a shift of 1 second between the 64channels blocks. In rare circumstances, a fixed 1-second temporal … — Micromed S.p.A. · Class II · Ongoing
Sterile anchors my lack sterility assurance. — Boston Scientific Neuromodulation Corporation · Class II · Ongoing
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. — Avanos Medical, Inc. · Class II · Ongoing
Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have reduced or missing dentin layer and when used clinically in the patient's mouth there is an increased risk of fractures under functional stress. — Sagemax Bioceramics, Inc. · Class II · Ongoing
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. — Avanos Medical, Inc. · Class II · Ongoing
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. — Avanos Medical, Inc. · Class II · Ongoing
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use. — D.O.R.C. Dutch Opthalmic Research Center Intl B.V. · Class II · Ongoing
A defect has been identified in the manufacture of the Fresh Roast Systems ColorTrack instrument model number BENCH R-100 which could under very rare specific misuse circumstances potentially allow human access to infrared laser light levels in excess of the safety Classification of the product. — Fresh Roast Systems Inc · Class II · Ongoing
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. — Avanos Medical, Inc. · Class II · Ongoing
Inadvertent distribution of sealed pouches that had not undergone validated sterilization. — AVID Medical, Inc. · Class II · Ongoing