Virginia recalls

Olympus Corporation is recalling certain Single Use 3-Lumen Sphincterotome V devices (model KD-VC412Q-0215) used in endoscopy procedures. Some devices may not have been properly heat-treated during manufacturing, which could cause them to deform and stop working correctly during use.

Olympus has recalled certain Single Use 3-Lumen Sphincterotome V devices (model KD-VC411Q-0330) used in endoscopic procedures. Some devices may not have been properly formed during manufacturing, which could cause them to deform and not work as intended during use.

Olympus Corporation is recalling certain Single Use 3-Lumen Sphincterotome V devices (Model KD-VC411Q-0320) used in endoscopic procedures. Some devices may not have been properly formed during manufacturing, which could cause them to deform and stop working properly during use.

Olympus Corporation of the Americas is recalling certain Single Use 3-Lumen Sphincterotome V devices (model KD-VC411Q-0730) used in endoscopic procedures. Some devices may not have undergone proper thermoforming during manufacturing, which could cause them to deform and lose their intended performance during use.

Olympus Corporation is recalling certain Single Use 3-Lumen Sphincterotome V devices (model KD-VC411Q-0720) used in endoscopic procedures. Some devices may not have been properly formed during manufacturing, which could cause them to deform and stop working as intended during medical procedures.

Olympus Corporation is recalling certain Single Use 3-Lumen Sphincterotome V devices (model KD-VC431Q-0730) used in endoscopic procedures. Some devices may not have undergone proper heat treatment during manufacturing, which could cause them to deform and stop working correctly during use.

Olympus has recalled certain single-use sphincterotome devices (model KD-V431M-0730) used during endoscopy procedures. Some devices may not have been properly formed during manufacturing and could deform or fail to work as intended during use.

Olympus has recalled certain Single Use 3-Lumen Sphincterotome V devices (model KD-V431M-0720) used in endoscopic procedures. Some devices may not have been properly formed during manufacturing, which could cause them to deform and stop working correctly during use.

Olympus Corporation of the Americas is recalling certain Single Use 3-Lumen Sphincterotome V devices (model KD-V411M-0730) used in endoscopic procedures. Some devices may not have undergone proper thermoforming, which could cause them to deform and not work as intended. No injuries have been reported.

Olympus is recalling certain batches of its Single Use 3-Lumen Sphincterotome V (model KD-V411M-0725), a surgical tool used during endoscopic procedures. Some devices may not have undergone proper manufacturing and could deform during use, affecting their performance. No injuries have been reported.

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.