FDA medical device recalls

Vantive US Healthcare is recalling Prismaflex M100 dialyzer sets because the deaeration chamber may separate from the control unit during use. This affects units manufactured on or after lot 24F0077CA. The FDA has classified this as a Class II recall.

Vantive US Healthcare is recalling certain OXIRIS dialyzer sets because a part called the deaeration chamber may come loose from the Prismaflex Control Unit during use. This could interrupt dialysis treatment. No injuries have been reported so far.

Vantive US Healthcare has recalled Prismaflex ST150 dialyzer sets because the deaeration chamber may become loose and detach from the control unit during use. This affects units manufactured on or after June 24, 2025. No injuries have been reported.

The deaeration chamber in certain Vantive Prismaflex ST100 dialyzer sets may detach from the control unit during use. This could interrupt treatment. The recall affects units manufactured on or after lot 24G0072.

Olympus is recalling its Single Use Electrosurgical Knife model KD-645L because the cutting tip can overheat, deteriorate, and break during surgery. This may occur in certain lot numbers manufactured between specific production runs. No injuries have been reported.

Olympus Corporation is recalling certain single-use electrosurgical knives (model KD-640L) used during endoscopic surgery. The cutting knife can overheat, burn, and break during use, which could affect the surgery. No injuries have been reported.

Beckman Coulter has recalled specific lots of COULTER DxH Diluent and COULTER DxH ECO Diluent used in blood cell analysis systems. These affected lots can produce inaccurate platelet count readings during daily quality checks, which may lead to unreliable test results.

Boston Scientific's AXIOS Stent (a medical device used in certain procedures) may fail to deploy or expand properly during use. If the stent does not expand as intended, patients may need additional procedures—either endoscopic or surgical—to remove the stent and repair the site.

Boston Scientific is recalling certain AXIOS Stents (8mm x 8mm) due to reports of deployment and expansion problems during use. If a stent fails to deploy properly, patients may need additional procedures to remove it and repair the puncture site.

Boston Scientific's HOT AXIOS Stent (6mm × 8mm) may fail to deploy or expand properly during placement. If the stent does not expand correctly, patients may need additional endoscopic or surgical procedures to remove it and repair the puncture site.

Boston Scientific is recalling certain AXIOS Stents (8mm x 8mm) used in medical procedures because they may not deploy or expand properly. If the stent fails to deploy correctly, additional procedures may be needed to remove it and repair the puncture site.

Boston Scientific has recalled certain AXIOS Stents (6mm x 8mm) due to reports of problems with stent deployment and expansion during procedures. In some cases, the stent may not deploy properly, potentially requiring additional procedures to remove it and repair the site. No injuries have been reported.

Boston Scientific has recalled specific lots of the AXIOS Stent and Electrocautery-Enhanced Delivery System (20mm x 10mm) due to reports of stent deployment and expansion problems. In some cases, the stent may not deploy or expand properly, which could require additional procedures to remove the stent and repair the puncture site.

Miach Orthopaedics BEAR Implant Model 1000 units have an incorrect expiration date printed on the label that extends beyond the product's actual shelf life. Because the expiration date is wrong, the UDI (Unique Device Identifier) is also incorrect. This affects 284 units distributed nationwide.

LSL Healthcare's Central Line Dressing Kit (Model 2519CP) contains BD ChloraPrep Triple Swabsticks with damaged packaging—some applicator seals are open. An open seal can allow the sterile applicator to become contaminated before use. This affects about 1,400 kits distributed in Idaho with lot number 5G3119 and expiration date 7/31/26.

LimFlow Vector vascular devices (Model VT-US-23, Lot 82321838) were distributed with an incorrect expiration date printed on the packaging. This affects 33 units distributed across multiple U.S. states. An incorrect expiration date could lead to use of a device beyond its safe lifespan.

Some BD Alaris Pump Module 8100 infusion pumps have a software date/time issue related to daylight saving time that may prevent them from connecting to hospital networks. This affects only the network connectivity function; the pump's ability to deliver medication is not impacted. The issue involves 189 devices distributed in Arizona, Indiana, Ohio, and Virginia.

Philips SmartPath to dStream MR imaging systems with software versions R11.1 and R12.1 may display incorrect stiffness values when MR Elastography maps are exported to a PACS viewer. This could affect the accuracy of tissue stiffness measurements used for clinical assessment. Three units have been identified worldwide.

Philips dStream 3.0T MRI systems with software versions R11.1 and R12.1 may display incorrect stiffness values when elastography images are sent to picture archiving systems (PACS). This affects the accuracy of tissue stiffness measurements used in clinical diagnosis.

Philips MR 7700 MRI systems running software versions R11.1 or R12.1 may display incorrect stiffness values when MR Elastography images are exported to a PACS viewer. This could affect the accuracy of tissue stiffness measurements used in clinical evaluation.

Philips MR 7700 MRI systems with software versions R11.1 and R12.1 may display incorrect stiffness values when elastography maps are exported to medical imaging viewing systems. This affects 9 units worldwide. No injuries have been reported.

Philips Ingenia Elition X MRI systems with certain software versions (R11.1 and R12.1) may display incorrect stiffness values when MR elastography maps are exported to a PACS viewer. This could lead to misinterpretation of tissue stiffness measurements used in clinical diagnosis.

Philips Ingenia Elition S MRI systems with software versions R11.1 and R12.1 may display incorrect stiffness values when MR Elastography maps are exported to a PACS (Picture Archiving and Communication System). This could affect the accuracy of tissue stiffness measurements used in clinical evaluation. Five units worldwide have been identified.

Philips has identified a potential error in how stiffness values are displayed when MR Elastography (MRE) images are exported to a PACS viewer on certain Ingenia Ambition X MRI systems. This affects 21 systems worldwide running software versions R11.1 or R12.1. The error could result in incorrect stiffness measurements being shown to clinicians.

Philips has recalled certain Ingenia Ambition S. MRI systems (software versions R11.1 and R12.1) because they may display incorrect stiffness values when MR Elastography images are sent to a PACS (picture viewing system). This could affect the accuracy of medical imaging data used for diagnosis.

Philips has recalled certain Ingenia 3.0T CX MRI systems (software versions R11.1 and R12.1) because stiffness values displayed in exported elastography maps may be inaccurate when viewed in a PACS (Picture Archiving and Communication System). This affects 6 units worldwide, primarily in the United States and Europe.

Philips has identified a software issue in certain Ingenia 3.0T MRI systems that may cause incorrect stiffness values to appear when viewing elastography images on a PACS (picture viewing system). This affects 24 systems worldwide with specific software versions. No injuries have been reported.

Philips has recalled certain Ingenia 1.5T MRI systems with software versions R11.1 and R12.1. When MR Elastography stiffness maps are exported to a PACS viewer, the stiffness values may display incorrectly. This could affect the accuracy of diagnostic information viewed in those systems.

Philips MR systems (Evolution Upgrade 3.0T, software versions R11.1 and R12.1) may display incorrect stiffness values when MR Elastography maps are exported to a PACS viewer system. This could affect the accuracy of imaging data used in clinical assessment.

Philips Evolution Upgrade 1.5T MRI systems with software versions R11.1 and R12.1 may display incorrect stiffness values when elastography maps are exported to a PACS viewer. This could affect the accuracy of tissue stiffness measurements used in clinical diagnosis. Three units have been identified worldwide.