Medical device recalls

These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025

Medline Industries is recalling certain reprocessed Webster CS Catheters because they may contain small particles of leftover material from cleaning. If used, these particles could trigger inflammation, infection, blood clots, or serious complications like stroke or lung clots.

Philips has recalled three Spectral CT 7500 CT scanner systems because fasteners that secure the rotor inside the gantry may not have been tightened to the correct specification. If multiple fasteners are loose, rotor parts could become unsecured or displaced during operation. No parts have been expelled or injuries reported so far.

Philips has recalled certain Spectral CT imaging systems because fasteners that hold the rotor in place inside the gantry may not be properly tightened. If multiple fasteners are loose, rotor parts could potentially become displaced or expelled during operation. No injuries or equipment failures have been reported so far.

Philips has identified that fasteners holding the rotor in place inside certain IQon Spectral CT scanners may not be properly tightened. While no equipment failures or injuries have been reported, loose fasteners could theoretically cause rotor parts to become unsecured during operation.

Philips has recalled certain Brilliance iCT CT scanners because fasteners that secure the rotor inside the gantry may not be tightened to the correct specification. If multiple fasteners are loose, rotor parts could potentially become displaced or expelled during scanning. No injuries or incidents have been reported.

Hologic's Brevera Breast Biopsy System disposable 9 gauge needles may contain tiny particles that could be deposited into breast tissue during a biopsy procedure. This affects approximately 681,870 units distributed nationwide. No injuries have been reported so far.

Medline Industries intubation kits (SKU DYNJAA245B, lots 25IBC172 and 25HBJ413) may contain an 8 Fr suction catheter instead of the correct 14 Fr size. The smaller catheter can block the airway during intubation, potentially causing severe breathing problems or failure that requires emergency intervention.

Some Medline 14 Fr Suction Catheter Kits (SKU DYND40972) may contain a smaller 8 Fr catheter instead of the correct 14 Fr size. Using the wrong size catheter can partially or completely block the airway, leading to low oxygen levels and breathing failure that may require emergency treatment.

The mounting bolt on ETAC Molift 4-point sling bars (models 1430116, 1430117, 1430115) can break during assembly or use due to material deformation at the joint. This can cause the lifting bar to lose proper function, affecting the safety and reliability of the mobile hoist. About 25 units have been distributed worldwide.

The mounting bolt on Molift 2-point sling bars (models 1530101 and 1530102) can break during assembly or use due to material deformation. This can limit the joint's movement and prevent the hoist from working properly. No injuries have been reported.

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.