South Dakota recalls

The bolt that connects the lifting bar to the arm on certain Molift Mover 300 hoists can break due to material deformation in the joint. This can cause the lifting mechanism to become immobile and stop working properly, creating a safety risk during patient transfers.

The mounting bolt that holds the lifting bar on certain Molift Mover 205 patient lifts can break during use. This happens because materials in the joint deform over time, which can cause the bolt to fail and limit how the lift moves. A bolt broke during testing, prompting this recall.

Fujirebio is recalling quality control materials used in Alzheimer's disease testing labs. The controls may give falsely high or indeterminate results, causing patients to be incorrectly classified as having amyloid pathology or to receive unnecessary additional testing. This affects Model 81559, Lot T8B6116U, distributed in 13 U.S. states.

Fujirebio Diagnostics is recalling calibrator kits (model 235454, specific lot numbers) used in a blood test for Alzheimer's disease risk. The calibrators may cause inaccurate results, falsely flagging patients as positive or indeterminate for amyloid pathology when they should not be, or missing cases that should be detected.

Fujirebio Diagnostics is recalling Lumipulse G β-Amyloid 1-42 Plasma test cartridges (Model 235447, certain lot numbers) because they may produce falsely high or falsely indeterminate results. This could incorrectly classify patients as having Alzheimer's disease pathology or unnecessarily recommend further testing. Healthcare providers should stop using affected cartridges immediately.

Fujirebio Diagnostics is recalling Lumipulse pTau 217 Plasma Controls (Model 81558) used in laboratory testing for Alzheimer's disease markers. The controls may produce falsely elevated results, leading labs to incorrectly classify patients as having Alzheimer's disease or requiring additional testing.

Fujirebio Diagnostics' Lumipulse G pTau 217 Plasma Calibrators (Model 81557) may produce inaccurate test results, causing patients to be incorrectly classified as having Alzheimer's-related amyloid pathology or flagged for unnecessary additional testing. The calibration issue leads to falsely elevated results that do not match established imaging and CSF tests.

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.