Connecticut recalls

Fujirebio's Lumipulse G pTau 217 Plasma test cartridges (Model 81550) may produce inaccurate results, incorrectly classifying patients as having Alzheimer's-related amyloid pathology or flagging them for unnecessary further testing. The cartridges show higher rates of false-positive and false-indeterminate results compared to FDA-approved reference tests. Affected lot numbers are D4C6028U, D4C6029U, D4C6051U, and D4C6052U.

Fujirebio's Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio test may produce inaccurate results that falsely suggest Alzheimer's disease or incorrectly flag patients for additional testing. The test can show higher-than-actual ratios, leading to wrong patient classifications compared to confirmed imaging or cerebrospinal fluid tests.

Maquet Cardiopulmonary identified a durability problem with the connecting cable on its Venous Bubble Sensor (Model 701055720). Excessive bending of the cable can damage the sensor or loosen the connection, causing error messages on the connected medical device—either temporarily when the cable moves or permanently if the connection fails.

FUJIFILM Healthcare Americas has recalled certain FDR Visionary Suite X-ray systems (Model CH-200) because internal electrical contacts can become welded together. This may allow power to continue flowing to the system even after it is turned off, which could cause the circuit to overheat, damage nearby parts, and create smoke.

Wilson-Cook Medical is recalling certain nasal jejunal feeding tubes (model NJFT-10) because some units were shipped without the nasal transfer tube component, making them incomplete and unusable. The recall affects 60 units distributed in Australia.

Olympus has recalled certain Single Use 3-Lumen Sphincterotome V devices (model KD-VC411Q-0725) used during endoscopic procedures. Some devices may not have undergone proper thermoforming during manufacturing, which could cause them to deform and lose performance during use.

Olympus has recalled certain Single Use 3-Lumen Sphincterotomes (Model KD-V411M-3025) used in endoscopic procedures. Some devices may not have been properly formed during manufacturing and could deform or stop working correctly during use.

Olympus has recalled certain Single Use 3-Lumen Sphincterotomes (model KD-V411M-3020) used in endoscopic procedures. Some devices may not have undergone proper manufacturing and could deform during use, affecting their ability to perform as intended.

Olympus has recalled certain Disposable Triple Lumen Sphincterotomes (model KD-401Q-0725) used in endoscopic procedures. Some devices may not have undergone proper manufacturing steps and could deform or lose performance during use.

Olympus Corporation of the Americas is recalling certain Disposable Triple Lumen Sphincterotomes (model KD-401Q-0320) used in endoscopic procedures. Some devices may not have undergone proper heat treatment and could deform during use, affecting their ability to perform correctly.

Olympus Corporation is recalling certain single-use 3-lumen sphincterotomes (model KD-V411M-3030) used in endoscopic procedures. Some devices may not have undergone proper thermoforming during manufacturing, which could cause them to deform and fail to work correctly during use.

Olympus is recalling certain Single Use 3-Lumen Sphincterotome V devices (model KD-V411M-1530) used in endoscopic procedures. Some devices may not have been properly formed during manufacturing, which could cause them to deform and lose performance during use.

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.