Medical device recalls

Olympus has recalled certain Single Use 3-Lumen Sphincterotome V devices (model KD-V411M-1520) used during endoscopic procedures. Some units may not have been properly heat-formed during manufacturing, which could cause them to deform and stop working as intended.

Olympus has recalled certain Disposable Triple Lumen Sphincterotome devices (Model KD-401Q-0730) because some units may not have undergone proper manufacturing. These devices could deform during use and may not perform as intended during papillotomy procedures.

Olympus Corporation of the Americas is recalling certain Disposable Triple Lumen Sphincterotomes (model KD-401Q-0720) used during endoscopic procedures. Some devices may not have undergone proper manufacturing and could deform during use, which may cause them to lose their intended performance.

Olympus Corporation has recalled certain Disposable Triple Lumen Sphincterotome devices (model KD-401Q-0330) used in endoscopic procedures. Some devices may not have undergone proper thermoforming, which could cause them to deform and fail to perform as intended during use.

Olympus has recalled certain Disposable Triple Lumen Sphincterotomes (model KD-411Q-0730) used during endoscopic procedures. Some devices may not have been properly heat-treated during manufacturing, which could cause them to deform and not work as intended during use.

Olympus Corporation of the Americas is recalling certain Disposable Triple Lumen Sphincterotomes (model KD-411Q-0720) used during endoscopy procedures. Some devices may not have undergone proper manufacturing and could deform during use, which would cause them to stop working correctly.

Olympus has recalled certain Single Use 3-Lumen Sphincterotome V devices (model KD-VC433Q-0730) used in endoscopic procedures because some units did not undergo proper thermoforming during manufacturing. These devices may deform and lose performance during use.

Olympus Corporation is recalling certain Single Use 3-Lumen Sphincterotome V devices (model KD-VC433Q-0720) used in endoscopic procedures. Some devices may not have been properly heat-formed during manufacturing, which could cause them to deform and stop working correctly during a procedure.

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.