Connecticut recalls

Olympus Corporation is recalling certain Single Use 3-Lumen Sphincterotome V devices (model KD-V411M-0720) used in endoscopy procedures. Some devices may not have been properly heat-treated during manufacturing, which could cause them to deform and stop working as intended during use.

Some Olympus sphincterotome devices (model KD-V411M-0330) may not have been properly processed during manufacturing. Devices that skipped a key heating step could deform and fail to work correctly during medical procedures.

Olympus has recalled certain Disposable Triple Lumen Sphincterotomes (model KD-431Q-0720) used in endoscopic procedures because some devices may not have been properly heat-treated during manufacturing. Affected devices could deform and lose their intended performance during use.

Olympus has recalled certain Single Use Sphincterotome V devices (model KD-VC431Q-0720) used in endoscopic procedures. Some devices in this batch may not have been properly heat-formed during manufacturing, which could cause them to deform and stop working correctly during use. No injuries have been reported.

Olympus has recalled certain CleverCut Single Use 3-Lumen Sphincterotome V devices (model KD-V411M-0320) used in endoscopy procedures. Some devices may not have been properly formed during manufacturing, which could cause them to deform and lose effectiveness during use. No injuries have been reported.

Vivoo urine test strips for sodium, vitamin C, and hydration were sold without required FDA approval and may provide false or inaccurate results. These tests are designed for home use and incorrect results could lead to unnecessary medical decisions. The affected products have specific lot numbers and expiration dates in 2026 and 2027.

Vivoo Vaginal pH Test strips were sold in the U.S. before receiving required FDA approval. The test may give false or inaccurate results, which could lead to unnecessary or inappropriate medical treatment based on incorrect information.

Vivoo Protein Test strips were sold in the U.S. before receiving required FDA approval. The tests may give false or inaccurate results, which could lead to unnecessary medical decisions based on incorrect information.

Vivoo pH Test strips were sold in the U.S. before receiving required FDA approval. The strips may give false or inaccurate results, which could lead to inappropriate medical decisions based on incorrect findings.

Exploro Highly Sensitive Male Fertility test strips were sold in the U.S. before receiving required FDA approval. These tests may give false or inaccurate results when used at home, potentially leading to unnecessary or inappropriate medical decisions.

Changchun Wancheng Bio-Electron Co., Ltd. distributed a home sperm fertility test kit without proper FDA approval. The test may give false or inaccurate results, which could lead to unnecessary or inappropriate medical decisions based on incorrect information.

Changchun Wancheng Bio-Electron distributed S. Typhi/Para Typhi A Antigen test strips in the U.S. before receiving required FDA approval. These test strips may produce false or inaccurate results when used by patients or untrained individuals, which could lead to wrong medical decisions.

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.