Medical device recalls

Changchun Wancheng Bio-Electron distributed urine-based menopause test kits (lot GT-FSH 20251601) without required FDA approval. These tests may give false or inaccurate results, potentially leading to unnecessary medical treatment.

Changchun Wancheng Bio-Electron distributed LH One Step Ovulation Test strips in the U.S. without required FDA approval. The tests may give false or inaccurate results, which could lead to wrong medical decisions.

The FDA found that Girlfriend Doctor Dr. Anna Cabeca Keto-pH, URIMED Urinalysis Reagent Strips URS-5, and Vivoo Ketone test strips were sold without proper FDA approval. These tests can give false or inaccurate results, which may lead to wrong medical decisions.

Several brands of over-the-counter urinary tract infection test strips were sold in the U.S. without proper FDA approval. These strips may give false or inaccurate results, which could lead to wrong treatment decisions or missed infections.

Vortex Surgical has recalled certain lots of the Lindsell Sutured IOL Marker (a scleral marker used in eye surgery) because the sterile Tyvek pouches may have small voids or openings in their seals. A compromised seal can allow bacteria to enter the package, which could contaminate the sterile device and lead to infection if used in surgery.

Vortex Surgical has recalled certain 25GA Backflush and 27GA Backflush Retractable surgical needles because their Tyvek sterile packaging pouches may have small voids in the seal. A damaged seal can allow bacteria to contaminate the needle, which could cause infection if used in surgery.

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Vortex Surgical Inc. is recalling certain lots of the Rumex Disposable Diamond Dusted ILM Elevator (catalog 12-7523) because the sterile packaging may have small voids in the seal. A compromised seal could allow bacteria or other contaminants to reach the surgical instrument, potentially leading to infection if used.

Vortex Surgical I2 Injection Kits (model VS0500) in certain lots may have small voids or gaps in the seal of their sterile Tyvek pouches. This damage can allow bacteria to contaminate the sterile contents, potentially causing infection if the kit is used.

Vortex Surgical Inc. is recalling Tecfen Retractable Membrane Polisher units (lot 2411013) because the Tyvek sterile pouches may have seal voids that compromise the sterile barrier. This could allow bacterial contamination and increase the risk of infection if the device is used.

Vortex Surgical has recalled certain batches of its 25GA I.D.D. Internal Delivery Device (model VS0250.25) because the Tyvek sterile pouches may have small voids or gaps in their seals. A compromised seal can allow bacteria or other contamination to enter the package, potentially leading to infection if the device is used.

Vortex Surgical Inc. is recalling three models of 25GA Convenience Kits because the Tyvek pouches may have voids or defects in their seals. A compromised seal can allow bacteria to contaminate the sterile contents, potentially leading to infection if the kits are used.

Vortex Surgical Inc. is recalling certain 25GA Subretinal Injection Cannula (model VS0220.25, Lot 2410043) because the sterile Tyvek pouches may have small voids or gaps in the seal. If a pouch is compromised, the cannula inside is no longer sterile and could become contaminated with bacteria, risking infection during eye surgery.

Vortex Surgical Inc. is recalling specific lots of disposable forceps and cannula instruments used in eye surgery because the Tyvek pouches protecting them may have seal voids. A compromised sterile barrier can allow bacterial contamination, potentially leading to infection during or after surgery.

Vortex Surgical has recalled certain Oertli laser probes used in eye surgery because the sterile packaging (Tyvek pouches) may have small voids or gaps in the seal. A compromised seal could allow bacteria to contaminate the sterile device, potentially leading to infection during surgery.

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.

Encore Medical discovered that some packages of EMPOWR Acetabular System hip implant liners contained the wrong device inside—for example, a box labeled as one size contained a different size. This packaging error could force surgeons to delay surgery or perform additional procedures to swap out the correct implant.

Encore Medical discovered that some packages of knee tibial inserts and acetabular (hip socket) system components contain the wrong device inside. This packaging error could delay surgery or require unexpected revision surgery if the mismatch is not caught beforehand.

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.