New York recalls

Olympus Corporation of the Americas is recalling POWERSEAL 5mm curved jaw sealer and divider devices due to incorrect labeling on the outer box. Some units labeled as 37 cm devices actually contain 23 cm devices, which could lead to confusion during surgical use. The issue affects 335 units distributed in the US, Australia, the European Union, and Japan.

IMRIS Imaging Inc has recalled certain ORT300 operating room tables because the rotational lock mechanism may fail mechanically, preventing the table from locking or unlocking as intended. This could allow unintended movement during surgery, potentially injuring a patient. The recall affects 13 units with specific serial numbers.

A mechanical failure in the linear actuator and rotational lock mechanism on certain IMRIS ORT200 operating room tables may prevent the table from locking or unlocking properly. If the table becomes unlocked unintentionally during surgery, it could move unexpectedly and injure the patient.

Medline has recalled four models of surgical convenience kits used in neurosurgery procedures because they contain a component that may be contaminated. The affected kits were distributed nationwide to healthcare facilities in 18 states.

Medline Industries recalled four surgical convenience kits because they contain a component that may be contaminated. The affected kits are used in minor lithotomy, major lithotomy, gynecological laparotomy, and universal gynecological procedures. A total of 419 kits were distributed nationwide.

Medline Industries recalled three C-Section surgical convenience kits because they contain a potentially contaminated component from a supplier. The affected kits were distributed nationwide across 18 states. No injuries have been reported.

Medline Industries recalled 14 types of surgical convenience kits used in hospitals and surgical centers because they contain a potentially contaminated component that was recalled by the component manufacturer. The kits are used for various surgical procedures including gynecology, cardiac, thoracic, and transplant operations. No injuries have been reported.

Medline Industries has recalled certain convenience kits (model LTP CDS-LF, SKU CDS980375M, lot 25JBE079) because they contain a component that may be contaminated. The recall affects 15 kits distributed nationwide.

Medline Industries is recalling four types of surgical convenience kits because they contain a potentially contaminated component supplied by a manufacturer. The recalled kits were distributed nationwide to medical facilities. No injuries have been reported.

Fresenius Medical Care has identified a problem with certain 2008T BlueStar hemodialysis machines that can cause flow, water supply, or temperature alarms to malfunction. These alarms are important safety features that alert clinical staff to problems during treatment. About 1,140 affected machines have been identified by serial number.

Specific lots of Henry Schein Structur 2 SC Temporary Resin Cartridge Refill were distributed with incorrect packaging and instructions for use. This dental material is used to make temporary crowns, bridges, inlays, and onlays. The incorrect instructions could affect proper use of the product.

Fixing screws on the ceiling movement gear of the suspended arm in Canon Medical Alphenix interventional X-ray systems may become loose over time. This could potentially cause the arm to shift during use. Ten systems are affected across eight U.S. states.

Certain Midmark Digital ECG machines running older software versions may display incorrect heart rhythm patterns and calculate inaccurate heart rates. This is due to a software communication issue that could affect the accuracy of patient test results.

Halyard TOTAL JOINT surgical kits (Model MSBM036-03, Lot 1649519) were distributed with labeling that failed to identify that the statlock component contains natural rubber latex. Patients or healthcare workers with latex allergies could face a serious allergic reaction if exposed.

Halyard TOTAL JOINT surgical kits (Model MSBM036-03) were distributed with incomplete labeling that failed to warn users that the statlock component contains natural rubber latex. This omission creates a risk for patients and healthcare workers with latex allergies. Approximately 120 kits were affected in Mississippi and Texas.

Halyard TOTAL JOINT medical kits (Model MSBM036-03, Lot 1632948) contain a statlock component made of natural rubber latex, but the kit labeling does not warn of this. People with latex allergies could have a serious allergic reaction if exposed during use.

Halyard's DAVINCI TRUCUSTOM medical kit contains a Statlock component made with natural rubber latex, but the product labeling does not warn of this. People with latex allergies could have a serious reaction if exposed during use.

Merge Healthcare's PACS and OrthoPACS medical imaging workstations contain a software issue that may cause measurements to be displayed inaccurately. Version 9.5 is affected. The issue was identified in 20 units distributed across California, Florida, Kentucky, Nebraska, and Washington.

American Contract Systems Convenience Kits containing Medline Red Rubber Intermittent Catheters did not meet required performance specifications. The affected kits were distributed in Iowa and Ohio.

Medline Industries distributed 45 tracheostomy tube kits (SKU DYKM2330) with incorrect component labeling. The discrepancy between the kit label and its contents could lead to confusion during use. No injuries have been reported.

Hollister has identified a manufacturing defect in select lots of Onli Hydrophilic Urethral Intermittent Catheters that may cause a protrusion on the catheter tip. This defect could lead to genitourinary trauma or bleeding during use.

Certain lots of Medline neuro surgical convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips have higher-than-allowed levels of endotoxin, a bacterial substance that can trigger immune responses. These kits are used in neurosurgical procedures. No injuries have been reported.

Specific lots of Medline medical convenience kits used in sinus, ENT, and head-and-neck procedures contain Pilling Wecksorb Neurosponges and Neurosponge Strips with elevated endotoxin levels that exceed safety specifications. Endotoxin is a bacterial substance that can trigger immune reactions if it comes into contact with sensitive tissues during surgery.

Medline's Hudson RCI heated breathing circuits for newborns and infants may experience sporadic failure in the heated wire connector at the humidifier. The connector can show discoloration, melting, smoke, or burning odor. This failure could reduce oxygen delivery and increase risk of airway problems in infants using the device.

Medline's heated wire breathing circuits for newborns and infants may fail unexpectedly. The heated connector at the humidifier can discolor, melt, or show signs of heat damage, which could cause the circuit to stop working or allow fluid to enter the airway.

The heated wire connector in Medline Hudson RCI neonatal and infant breathing circuits may fail unpredictably, causing discoloration, melting, smoke, or burning. If the circuit fails, infants may experience airway obstruction, difficulty breathing, or fluid pooling in the airway.

Horizon Organic 1% chocolate milk in 8 oz cartons (sold in 12-count and 18-count multipacks) may be spoiled. The affected products have best-by dates between January 28 and February 3, 2027, and were distributed across the United States.

Byron White Formulas A-FNG herbal supplement contains walnuts but does not declare this allergen on the label in English. The affected product is sold in 1.0 fl. oz./30 mL bottles. People with tree nut allergies who consume this product could have a serious allergic reaction.

Byron White Formulas A-P herbal supplement (1.0 fl. oz./30 mL) contains walnuts but does not declare them on the label in English. This poses a risk to people with nut allergies. The affected product was distributed across the U.S., Canada, and several other countries.

Byron White Formulas A-L Complex herbal supplement bottles do not display walnut allergen information in English on the label, even though the product may contain walnuts (black walnut hull). This creates a serious risk for people with nut allergies who rely on label warnings.