Medical device recalls

Medline medical procedure kits containing Stryker Strykeflow 2 Suction Irrigators have a design flaw that allows irrigation fluid to leak into the handpiece and battery pack during use. Some devices have leaked or released vaporized saline that may resemble smoke. This affects specific thoracic and cardiac robotic surgery kits distributed nationwide.

Diagnostica Stago is recalling lot 271288 of the Asserachrom HPIA test kit, which detects antibodies related to heparin-induced thrombocytopenia (HIT type II). The affected lot may have defective test wells that produce false negative results, meaning the test could fail to detect the condition when it is present.

Heraeus Medical's PALACOS MV pro bone cement systems (models 5150633 and 5150635) have experienced increased reports of ampoule breakage during use. When ampoules fail to break properly or incompletely, the cement cannot form correctly and cannot be used in surgery.

Heraeus Medical's PALACOS MV+G pro bone cement (models 5081290 and 5081291) may have ampoules that fail to break properly during mixing. When ampoules don't break as intended, the cement cannot form correctly and cannot be used during surgery.

Heraeus Medical is recalling PALACOS R+G pro bone cement (models 5081288 and 5081289) because the ampoules inside the mixing system may fail to break properly. When ampoules don't break as intended, the cement cannot be prepared correctly for use during surgery.

Heraeus Medical is recalling PALACOS R pro 40 and R pro 80 bone cement products because the ampoules (small sealed containers) inside the mixing systems may not break properly during use. When ampoules fail to break, the bone cement cannot be prepared correctly and cannot be used during surgery.

Philips Medical Systems has recalled Azurion Systems R3.0 due to nine software issues that may cause X-ray loss, system restarts, display problems, or imaging misalignment during procedures. These issues could affect image quality and system reliability in clinical use.

Certain versions of Elekta's MOSAIQ oncology information system may deliver twice the intended radiation dose to cancer patients under specific conditions involving partial treatments and interrupted fields. This could occur when the system fails to verify the correct dose amount after a treatment interruption. The issue affects systems using particle therapy with certain software versions.

Philips identified that 8 Allura Xper FD20/20 X-ray systems may be missing a drip tray beneath the cooling unit due to incomplete installation or documentation during previous repairs. If the tray is not in place, coolant liquid could contact electrical components and cause a short circuit, potentially shutting down the system.

Philips identified that a small number of Allura Xper FD20/10 X-ray systems may be missing a drip tray that should be installed beneath the cooling unit. Without this tray, coolant liquid could contact electrical components and cause short-circuits, potentially shutting down the system.

Philips identified that in 2 Allura Xper FD20 X-ray systems, the drip tray under the cooling unit was not installed or not properly documented during previous maintenance. If missing, coolant liquid could contact electrical parts and cause a short circuit, leading to system shutdown.

Philips has identified that some Allura Xper FD10/10 X-ray systems may be missing a drip tray that was supposed to be installed beneath the cooling unit during a previous service. Without this tray, coolant liquid could contact electrical components and cause a short circuit, potentially shutting down the system.

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

Philips identified that in a small number of operating room tables, a drip tray beneath the cooling unit may not have been installed during previous maintenance, or the installation was not properly documented. If missing, coolant could leak onto electrical components and cause a short circuit, potentially shutting down the system.

Philips identified that some Allura Xper FD20 Biplane X-ray systems may be missing a drip tray under the cooling unit, either from incomplete past repairs or undocumented installation. Without this tray, coolant liquid could leak onto electrical components and cause short-circuits that shut down the system.

Philips identified that some Allura Xper FD20 X-ray systems may be missing a drip tray beneath the cooling unit due to incomplete previous service work. If the tray is not installed, coolant can leak onto electrical components and cause a short circuit, potentially shutting down the system.

Philips identified that some Allura Xper FD10/10 X-ray systems may be missing a drip tray that protects electrical components from coolant liquid. If the tray was not installed during a previous service, coolant could contact electrical parts and cause a short circuit, potentially shutting down the system.

Philips identified that in 56 X-ray systems worldwide, a drip tray beneath the cooling unit may not have been installed during previous maintenance, or the installation may not have been properly documented. If missing, coolant liquid could contact electrical components and cause a short circuit, potentially shutting down the system.

Philips has identified that 18 Allura Xper FD20 Biplane X-ray systems worldwide may be missing a drip tray beneath the cooling unit due to incomplete field repairs or missing documentation. Without this tray, coolant liquid could contact electrical components and cause short circuits that shut down the system.

Philips identified that some Allura Xper FD20 X-ray systems may be missing a drip tray beneath the cooling unit from previous service work. Without this tray, coolant could leak onto electrical components and cause a short circuit, potentially shutting down the system during use.

Philips identified that 14 of their Allura Xper FD10/10 X-ray systems may be missing a drip tray beneath the cooling unit. Without this tray, coolant liquid could contact electrical parts and cause a short-circuit, potentially shutting down the system.

Philips identified that some Allura Xper FD10 X-ray systems may be missing a drip tray beneath the cooling unit due to incomplete field repairs. If the tray is not in place, coolant can leak onto electrical components and cause short-circuits, potentially shutting down the system.

Philips identified that some Allura Xper FD10F imaging systems may be missing a drip tray beneath the cooling unit due to incomplete field corrections. If the drip tray is not in place, coolant liquid could contact electrical components and cause short-circuits, potentially shutting down the system.

Philips has identified that some Allura Xper FD10C X-ray systems may be missing a drip tray that sits beneath the cooling unit, or the installation was not properly documented during previous maintenance. Without this tray, coolant liquid could leak onto electrical components and cause short circuits, potentially shutting down the system.

BD Ready-to-Use Hydrophilic Catheters (14 Fr, straight tip, model RTU14F) distributed in Georgia have an incorrect expiration date printed on the label. This labeling error means the actual shelf life of the product may differ from what is shown. No injuries have been reported.

Medline surgical kits containing B. Braun IV Administration Sets have been recalled because the check valve components may become stuck in the open or closed position. This could affect fluid flow during medical procedures. The recall affects four specific surgical kit types distributed nationwide.

Medline kits containing B. Braun IV administration sets have been recalled because the check valve components may become stuck in either the open or closed position. This could affect proper fluid delivery through the IV line. The affected kits are labeled as Neuro Angio Pack with SKU DYNJ38935, lot number 25IBC144.

Medline kits containing B. Braun IV Administration Sets may have check valve components that can become stuck in the open or closed position. This could affect proper fluid delivery during IV administration. About 1,725 units are affected nationwide.

Medline pre-op kits containing B. Braun IV administration sets have been recalled because the check valve components inside can get stuck in either the open or closed position. This could affect proper fluid delivery during medical procedures. No injuries have been reported to date.

Medline has recalled five IV starter kits that contain B. Braun IV administration sets. The check valve components in these sets may become stuck in the open or closed position, which could affect proper IV fluid delivery. No injuries have been reported so far.