Recalls and safety alerts from the FDA, newest first.
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
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
Inadvertent distribution of sealed pouches that had not undergone validated sterilization. — AVID Medical, 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
Due to incorrect incubation process being performed on product. — HF Acquisition Co LLC · Class II · Ongoing
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs. — Elekta, Inc. · Class II · Ongoing
Reusable electrodes may not meet expected performance levels. — Boston Scientific Neuromodulation Corporation · 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
A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge. — Siemens Healthcare Diagnostics, 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
Due to incorrect incubation process being performed on product. — HF Acquisition Co 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
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery. — ICU 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
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
Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use for treatment. This issue presents the potential of a slip and fall hazard associat… — 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
System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events. — Philips North America 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
Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking. — Boston Scientific Corporation · Class II · Ongoing