Oregon recalls

Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.

W L Gore & Associates has recalled specific batches of the GORE TAG Thoracic Branch Endoprosthesis Side Branch Component due to a risk of catheter separation during use. This is a surgical implant used to repair certain aortic conditions. The separation could potentially affect the device's ability to function as intended.

Masimo Corporation is recalling certain Radius VSM Disposable NIBP Cuff devices due to two issues: the ECG electrode may incorrectly detect abnormal heart rhythms in patients with normal heart rates, triggering false alarms that can distract clinicians; and small and medium-sized blood pressure cuffs may have rough edges that can irritate skin. These issues could delay proper treatment or patient discomfort in healthcare settings.

Masimo Corporation recalled its Radius VSM ECG pre-connected Set due to two issues: the ECG electrode assembly may incorrectly detect abnormal heart rhythms in patients with normal heart rates, triggering false alarms that can distract clinicians from real patient concerns; and small and medium blood pressure cuffs may have rough edges that can irritate skin.

Laborie Medical Technologies' Solar GI System water perfusion devices may accumulate moisture inside tubing, filters, and pressure sensors during extended clinical use. This moisture buildup can affect how the system measures airflow and pressure, potentially impacting test results.

Bard Access Systems is recalling soft tissue biopsy trays (Models 4380 and 4382A) because the lidocaine ampoules included in the kits were manufactured under deficient manufacturing practices. The affected trays are used by healthcare providers to collect tissue samples from patients.

Bard Access Systems is recalling certain Provena Midline Catheters because the lidocaine ampoules included with them were manufactured under deficient manufacturing practices. The catheters are used for short-term intravenous therapy, blood sampling, and contrast media injection. The defect affects multiple sizes and configurations across worldwide distribution.

Several models of Bard PowerPICC catheters included lidocaine ampoules (small vials) that were manufactured under deficient manufacturing practices. The lidocaine supplier has issued a recall of these ampoules due to quality concerns.

Lidocaine ampoules supplied with Bard's Groshong NXT ClearVue Catheter were manufactured under deficient practices. The supplier has initiated a recall of the affected ampoules due to these manufacturing concerns.

PowerPICC Provena peripheral catheters supplied with lidocaine ampoules manufactured under deficient manufacturing practices. The lidocaine ampoules are being recalled by the supplier due to quality concerns. These catheters are used for intravenous therapy, blood sampling, and central venous pressure monitoring in healthcare settings.

Bard Access Systems is recalling PowerMidline Catheters (4 Fr Dual-Lumen) because the lidocaine ampoules included with these devices were manufactured under deficient manufacturing practices. The affected catheters were distributed nationwide and internationally.

Bard Access Systems is recalling PowerMidline Catheters because the lidocaine ampoules (small vials) included with these catheters were manufactured under deficient manufacturing practices. The affected catheters are used for short-term intravenous access and blood sampling.

Bard Access Systems is recalling certain Power-Trialysis Slim-Cath short-term dialysis catheters because the lidocaine ampoules included with them were manufactured under deficient practices. The affected catheters are used to provide temporary vascular access for dialysis and related treatments.

Bard Access Systems is recalling multiple lots of Power-Trialysis short-term dialysis catheters because the lidocaine ampoules included with them were manufactured under deficient manufacturing practices. The affected catheters come in straight, curved extension, and Alphacurve styles with model numbers 5605150, 5605240, 5605300, 5615120, 5615200, and 5655120.

Bard Access Systems is recalling PowerPICC SV catheters (both 3 Fr and 4 Fr models) because the lidocaine ampoules included with these catheters were manufactured under deficient practices. These catheters are used for central venous access during intravenous therapy and blood sampling.

Bard Access Systems is recalling PowerPICC SOLO HF Catheters (5 Fr Triple-Lumen) because the lidocaine ampoules included with the kit were manufactured under deficient manufacturing practices. The affected lot (REKT1554) was distributed nationwide and internationally.

The lidocaine ampoules included with Bard's DuoGlide Short-Term Dialysis Catheters were manufactured under deficient practices and are being recalled by the supplier. The affected catheters are used for temporary vascular access during hemodialysis and related therapies.

Bard Access Systems is recalling Poly Midline Catheter kits (models CK000495A and CK000566) because the lidocaine ampoules included with them were manufactured under deficient practices. These catheters are used for short- or long-term peripheral venous access in hospitals and clinical settings.

Bard Access Systems is recalling three models of thoracentesis and paracentesis drainage trays because the lidocaine ampoules included in these kits were manufactured under deficient manufacturing practices. The affected trays are used to remove fluid from the chest or abdominal cavity during medical procedures.

The Shiley Disposable Decannulation Plug (DDCP), a red connector used on tracheostomy tubes to block airflow, carries labeling that incorrectly indicates it does not contain DEHP (a chemical compound). The product actually contains 30–35% DEHP. Users relying on the label may not be aware of DEHP exposure during use.

Certain Zeiss Intrabeam Spherical Applicator 1.5 cm units used in intraoperative radiation therapy did not meet manufacturing specifications. A total of 13 units were affected across the United States, Puerto Rico, and several other countries. No injuries have been reported.

Siemens has identified a potential issue with the Display ceiling suspension (DCS Fix XL) component on ARTIS icono ceiling systems. Over time, screws that secure the monitor to the suspension may gradually loosen, which could affect the stability of the mounted display.

RayCare 2024A SP4 oncology information system has a software issue where beam set delivery notes can lose data if modified at the same time or updated during an active treatment session. Users are not alerted when these changes occur, which could affect treatment record accuracy.

RayCare 2024A SP1 oncology information system has a software issue where beam set delivery notes can lose data if modified at the same time or updated during an active treatment session. Users may not be notified when these changes occur, potentially affecting treatment records.

Some Medela ENFit ExSet enteral extension sets contain incorrect connectors that may not attach properly to ENFit connections. This incompatibility could cause a slight delay in delivering nutrition or medication through the feeding tube.

In some cases, the collimator (a precision component) may not fully dock into the Cyberknife treatment system. This triggers a safety interlock that blocks motion from the operator console. However, if staff enter the treatment room and use the in-room control pendant to move the system, the collimator can release and fall from its housing, creating a potential impact hazard.

The Siemens ARTIS icono floor medical imaging system may lose movement capability when the detector lift height is adjusted to its maximum or minimum position. This affects 30 units with specific serial numbers distributed nationwide.

Siemens Medical Solutions USA is recalling the ARTIS icono ceiling model 11328100 due to a potential loss of movement capability when the detector lift height is adjusted to its maximum or minimum limits. This affects 119 units distributed nationwide.

Siemens Medical Solutions USA is recalling certain ARTIS icono biplane X-ray systems (Model 11327600) because the detector lift height may stop moving when adjusted to its maximum or minimum limits. This could prevent the equipment from operating normally during medical imaging procedures.

In some cases, the collimator (a precision component) may not fully dock into the Cyberknife system. If operators bypass the safety interlock by using the in-room control pendant, the collimator can release and fall from the machine housing. This affects 48 Cyberknife units worldwide running software version 11X or earlier.