Kentucky recalls

Vortex Surgical laser probes used in eye surgery may have small voids or gaps in their sterile packaging seals. If the seal is compromised, bacteria could contaminate the sterile device and cause infection during surgery. No injuries have been reported so far.

Volk Surgical's single-use vitrectomy lenses (Flat Vitrectomy Lens and Volk Magnifying Lens) in certain lots may have voids or breaks in their Tyvek sterile pouches. A compromised sterile barrier can allow bacterial contamination, which could lead to infection during eye surgery.

Focalyx Fusion, a software device used to guide prostate biopsies and diagnostic procedures, may not work properly on Windows 10 operating systems. This malfunction could harm patients during biopsy or delay needed treatment. The manufacturer recommends stopping use of affected software versions until the device is confirmed to work with Windows 11.

Siemens Medical Solutions USA is recalling three brain analysis software applications (syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities, and syngo.CT ASPECTS) installed on certain NAEOTOM Alpha.Pro CT systems. These applications were not cleared by the FDA before being distributed and must be removed from affected devices.

Siemens Medical Solutions distributed five CT imaging systems with three brain analysis software applications (syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities, and syngo.CT ASPECTS) that did not receive required FDA 510(k) clearance before use. No injuries have been reported.

Siemens Medical Solutions has recalled three software applications (syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities, and syngo.CT ASPECTS) installed on certain NAEOTOM Alpha CT systems. These applications were not cleared by the FDA before being distributed, which is required for medical imaging software.

Siemens Medical Solutions has recalled three software applications (syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities, and syngo.CT ASPECTS) installed on certain SOMATOM X.ceed CT scanners because these applications were not cleared by the FDA before being distributed. Two CT systems are affected worldwide.

Some Medtronic MiniMed 780G insulin pumps with software version 6.60 may experience a software timing issue that triggers an error code and stops insulin delivery. This affects specific catalog numbers (MMT-1884, MMT-1886) with certain serial numbers.

A specific lot of Tornier surgical screws (catalog DWJ318, lot AZ4824290) is labeled as 5.0mm×18mm but actually contains 5.0mm×14mm screws. If the wrong size is used without detection during surgery, it could increase the risk of mechanical failure and the need for revision surgery.

Biomerieux VITEK 2 Gram-negative Susceptibility Cards used to test bacterial resistance to certain antibiotics may produce incorrect results or fail quality control checks. The affected cards test bacteria such as E. coli and Pseudomonas aeruginosa against five antibiotic types. Inaccurate results could lead to inappropriate treatment decisions.

A software error in the Beckman Coulter CellMek SPS Sample Preparation System (model C44603, software version 2.3.90.0) causes samples to be dispensed incorrectly, potentially damaging the instrument and losing 60–100 microliters of sample fluid. This could lead to inaccurate test results and incorrect patient care decisions.

A software error allowed robotic instrument arms with bent or misaligned parts to remain in use during surgery. These parts can wear out and potentially fail during a procedure. Intuitive Surgical identified specific serial numbers of affected systems.

Vantive US Healthcare is recalling certain Prismaflex TPE2000 dialysis sets because the deaeration chamber may detach from the Prismaflex Control Unit during use. This could interrupt dialysis treatment. The recall affects units manufactured on or after June 2024.

The deaeration chamber in certain Prismaflex HF1000 dialyzer sets may become loose or detached from the Prismaflex Control Unit during use. This could affect the proper function of the dialysis equipment. The recall affects units manufactured on or after lot 24F0094CA.

Vantive US Healthcare is recalling Prismaflex HF1000 dialyzer sets because the deaeration chamber may come loose from the Prismaflex Control Unit during use. This affects units manufactured on or after lot 24G0034CA. No injuries have been reported.

Vantive US Healthcare is recalling Prismaflex M150 dialyzer sets because the deaeration chamber may separate from the Prismaflex Control Unit during use. This could disrupt dialysis treatment. The recall affects units manufactured on or after June 24, 2024.

Vantive US Healthcare is recalling Prismaflex M100 dialyzer sets because the deaeration chamber may separate from the control unit during use. This affects units manufactured on or after lot 24F0077CA. The FDA has classified this as a Class II recall.

Vantive US Healthcare is recalling certain OXIRIS dialyzer sets because a part called the deaeration chamber may come loose from the Prismaflex Control Unit during use. This could interrupt dialysis treatment. No injuries have been reported so far.

Vantive US Healthcare has recalled Prismaflex ST150 dialyzer sets because the deaeration chamber may become loose and detach from the control unit during use. This affects units manufactured on or after June 24, 2025. No injuries have been reported.

The deaeration chamber in certain Vantive Prismaflex ST100 dialyzer sets may detach from the control unit during use. This could interrupt treatment. The recall affects units manufactured on or after lot 24G0072.

Olympus is recalling its Single Use Electrosurgical Knife model KD-645L because the cutting tip can overheat, deteriorate, and break during surgery. This may occur in certain lot numbers manufactured between specific production runs. No injuries have been reported.

Olympus Corporation is recalling certain single-use electrosurgical knives (model KD-640L) used during endoscopic surgery. The cutting knife can overheat, burn, and break during use, which could affect the surgery. No injuries have been reported.

Beckman Coulter has recalled specific lots of COULTER DxH Diluent and COULTER DxH ECO Diluent used in blood cell analysis systems. These affected lots can produce inaccurate platelet count readings during daily quality checks, which may lead to unreliable test results.

Boston Scientific's AXIOS Stent (a medical device used in certain procedures) may fail to deploy or expand properly during use. If the stent does not expand as intended, patients may need additional procedures—either endoscopic or surgical—to remove the stent and repair the site.

Boston Scientific is recalling certain AXIOS Stents (8mm x 8mm) due to reports of deployment and expansion problems during use. If a stent fails to deploy properly, patients may need additional procedures to remove it and repair the puncture site.

Boston Scientific's HOT AXIOS Stent (6mm × 8mm) may fail to deploy or expand properly during placement. If the stent does not expand correctly, patients may need additional endoscopic or surgical procedures to remove it and repair the puncture site.

Boston Scientific is recalling certain AXIOS Stents (8mm x 8mm) used in medical procedures because they may not deploy or expand properly. If the stent fails to deploy correctly, additional procedures may be needed to remove it and repair the puncture site.

Boston Scientific has recalled certain AXIOS Stents (6mm x 8mm) due to reports of problems with stent deployment and expansion during procedures. In some cases, the stent may not deploy properly, potentially requiring additional procedures to remove it and repair the site. No injuries have been reported.

Boston Scientific has recalled specific lots of the AXIOS Stent and Electrocautery-Enhanced Delivery System (20mm x 10mm) due to reports of stent deployment and expansion problems. In some cases, the stent may not deploy or expand properly, which could require additional procedures to remove the stent and repair the puncture site.

B.C. Williams Bakery Service, Inc. is recalling Swiss Chocolate Cake Mix because it contains milk that is not listed on the label. This poses a serious risk to anyone with a milk allergy. The affected product was distributed nationwide in 50 lb. bags with lot codes 072925-220 and 071825-36.