Virginia recalls

GE HealthCare identified a potential problem with fasteners that secure the canopy soffit (the cover beneath the control panel) on Giraffe OmniBed infant incubators and warmers. During transport or impact, one or more of these fasteners can come loose and fall into the patient compartment. In rare cases, multiple fasteners can disengage, causing the soffit to become loose or detach.

ConMed Corporation is recalling certain lots of AirSeal 12mm Access Port and Palm Grip Obturator devices used during laparoscopic surgery. The devices may generate false overpressure alerts that could disrupt surgical procedures.

ConMed has recalled certain lots of its AirSeal 12mm Access Port with Low Profile Obturator (a surgical instrument used in minimally invasive laparoscopic procedures) due to a potential malfunction in the overpressure alert system. The affected devices may fail to properly alert during elevated pressure conditions.

ConMed has recalled certain lots of the AirSeal 12mm Access Port with Palm Grip Obturator (catalog number iAS12-150LPI), a surgical trocar used in laparoscopic procedures. The device may generate overpressure alerts during use, which could affect the surgeon's ability to maintain proper insufflation during surgery.

ConMed Corporation is recalling certain batches of the AirSeal 5mm Access Port with Low Profile Obturator (catalog number iAS5-100LP), used during laparoscopic surgery to maintain gas pressure in the abdomen. The device may generate overpressure alerts that could affect surgical workflow. No injuries have been reported.

ConMed Corporation has recalled certain lots of the AirSeal 5mm Access Port and Low Profile Obturator (catalog number iAS5-120LP), a disposable surgical trocar used in laparoscopic procedures. The device may generate overpressure alerts during use. This recall affects approximately 196,751 units distributed nationwide and internationally from June 2024 through January 2026.

ConMed has recalled certain lots of the AirSeal 5mm Access Port with Low Profile Obturator, a surgical instrument used in laparoscopic procedures. The device may generate overpressure alerts that could affect proper operation during surgery.

ConMed Corporation is recalling certain AirSeal 8mm Access Port and Low Profile Obturator devices (catalog number iAS8-100LP) used in laparoscopic surgery. The devices may generate false overpressure alerts during use. No injuries have been reported.

ConMed Corporation is recalling specific lots of its AirSeal 8mm Access Port with Low Profile Obturator (catalog number iAS8-120LP) used in laparoscopic surgery. The device may generate overpressure alerts that could affect proper operation during procedures. The recall affects approximately 55,694 packs distributed nationwide and internationally.

ConMed Corporation recalled certain AirSeal 12mm Access Ports (catalog number iASB12-100) used in laparoscopic surgery due to a potential for overpressure alerts. The affected devices were manufactured between June 2024 and January 2026, and were distributed nationwide and internationally.

ConMed Corporation is recalling certain AirSeal 12 mm Access Port and Obturator units (catalog iASB12-120) used in laparoscopic surgery because they may fail to generate proper overpressure alerts. This could allow pressure levels to rise unexpectedly during procedures. The affected units were manufactured between June 2024 and January 2026.

ConMed Corporation is recalling certain AirSeal 5mm Smooth Access Ports (Catalog Number iASB5-150) used in laparoscopic surgery. The device may generate overpressure alerts during use, which could affect surgical workflow or require device replacement during a procedure.

Stryker identified that some Triathlon Universal Baseplate Size 3 units (lot UZD9IB) were packaged in boxes labeled as Size 4, while Size 4 units (lot TYX7OB) were packaged in boxes labeled as Size 3. This labeling mix-up could result in using the wrong implant size during surgery.

Accriva Diagnostics' directCHECK ACT-LR whole blood quality control product (level 2, lot A6DLA001) has incorrect performance range information on its label. This labeling error could lead to misinterpretation of test results if the correct reference range is not known.

AMD Medicom Inc. is recalling Ritmed Neurological Sponges (0.75x0.75in, Sterile, REF: 85995C) used during brain surgery because some units may not meet safety standards for endotoxin—a bacterial byproduct that can cause harmful reactions in the cerebrospinal fluid. Elevated endotoxin levels could lead to fever, inflammation, low blood pressure, nausea, or neurological complications.

Ritmed Neurological Sponges used during brain surgery may contain elevated endotoxin levels. Endotoxins are bacterial contaminants that can trigger inflammation, fever, or temporary blood pressure drops when sponges contact cerebrospinal fluid during surgery.

Medtronic has identified a firmware anomaly in the O-arm O2 Imaging System detector panel that can cause image artifacts during surgical imaging. The issue affects specific serial numbers of the O-arm O2 model BI70002000. No injuries have been reported.

The plus and minus buttons used to control light intensity on Steris ALYON Surgical Lighting System light heads may detach during use. This affects 549 units distributed nationwide. No injuries have been reported.

The plus and minus buttons (+/-) on the light heads of Steris HarmonyAIR A-Series Surgical Lighting Systems may detach during use. This could affect the ability to control light intensity in the operating room. No injuries have been reported.

Paint on the light heads of Steris HarmonyAIR A-Series Surgical Lighting Systems may chip or peel. This could potentially affect the lighting system's performance or introduce debris into the surgical field. The FDA has classified this as a Class II recall.

Medline convenience hysterectomy kits contain a recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. The butyrate tubing in these kits may crack when used, making the adhesive unusable for application.

Medline convenience kits used in C-section procedures contain a recalled adhesive product with defective tubing that may crack during use, making the adhesive unusable. The affected kits were distributed nationwide. No injuries have been reported.

Medline convenience kits contain a recalled batch of Ferndale Laboratories MASTISOL Liquid Adhesive with defective tubing. The butyrate tubing in these kits may crack when used, making the adhesive unusable for medical application.

Multiple Medline surgical convenience kits contain a recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive where the tubing may crack during use, making the adhesive unusable. This affects kits used in cardiac, vascular, and pacemaker procedures.

Medline convenience kits for port-a-cath procedures contain a recalled batch of MASTISOL Liquid Adhesive from Ferndale Laboratories. The tubing in these kits may crack during use, making the product unusable.

Medline femoral block tray kits (model DYNJRA1739B) contain a recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. The tubing in these adhesive applicators may crack when used, making the product unusable for its intended application.

Medline surgical convenience kits contain a recalled lot of Mastisol Liquid Adhesive from Ferndale Laboratories. The adhesive's butyrate tubing can crack during use, making the product unusable in surgical settings. No injuries have been reported.

Medline convenience kits (Driveline Management Kit EBSI1688 and Port Dressing Change Kit EBSI1328A) contain a recalled adhesive product with defective tubing. The tubing may crack when used, making the adhesive unusable. About 49,600 kits have been distributed nationwide.

Medline convenience kits containing central venous catheter (CVC) insertion supplies include a recalled lot of adhesive that can cause the tubing to crack when used. This may render the kit unusable for the intended medical procedure. No injuries have been reported.

Several Medline convenience kits used for central line, PICC, dialysis, and port access dressing changes contain a recalled batch of Ferndale Laboratories MASTISOL Liquid Adhesive. The tubing in these adhesive bottles may crack when used, making the product unusable.