The latest headlines across every section, pulled from official and open-access sources.
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier. — Medline Industries, LP · Class I · Ongoing · 227 units
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 for in-vitro-cytotoxicity, which if in contact with a patient's vasculature could result in localized inflammation and tissue irritation. — PFM MEDICAL INC. · Class II · Ongoing · 32
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). — SURGIFY MEDICAL OY · Class II · Ongoing · N/A
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. — Medline Industries, LP · Class II · Ongoing · 113,843 kits
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. — Medline Industries, LP · Class II · Ongoing · 113,843 kits
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. — Medline Industries, LP · Class II · Ongoing · 113, 843 kits
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier. — Medline Industries, LP · Class I · Ongoing · 503 units
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. — Medline Industries, LP · Class II · Ongoing · 113,843 kits
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). — SURGIFY MEDICAL OY · Class II · Ongoing · N/A
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. — Medline Industries, LP · Class II · Ongoing · 113, 843 kits
GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches an interactive application (e.g. Volume Viewer), the application may open the previous patient's exam instead of the intended one. When this issue occurs, there is no system wa… — GE Medical Systems SCS · Class II · Ongoing · 340 servers
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design. — Medtronic Perfusion Systems · Class II · Ongoing · 134 units
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 loss of speaker output. — Philips North America Llc · Class II · Ongoing · 169 units
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). — SURGIFY MEDICAL OY · Class II · Ongoing · N/A
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). — SURGIFY MEDICAL OY · Class II · Ongoing · 53 units
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier. — Medline Industries, LP · Class I · Ongoing · 233 units
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. — TMJ Solutions Inc · Class II · Ongoing · 1
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier. — Medline Industries, LP · Class I · Ongoing · 6775 units
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). — SURGIFY MEDICAL OY · Class II · Ongoing · N/A
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. — Medline Industries, LP · Class II · Ongoing · 113,843 kits
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. — Medline Industries, LP · Class II · Ongoing · 113,843 kits
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). — SURGIFY MEDICAL OY · Class II · Ongoing · N/A
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). — SURGIFY MEDICAL OY · Class II · Ongoing · 15 units
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). — SURGIFY MEDICAL OY · Class II · Ongoing · N/A