Medical device recalls

Wilcox Industries has released a software enhancement designed to increase the safety of its BOSS Xe aiming devices. The company is notifying all customers who purchased these products that the update should be installed.

Moderate·FDA·Jul 29, 2026·Wilcox Industries

Tosoh Bioscience recalled certain lots of its ST AIA-Pack Testosterone test due to a quality control issue that can produce falsely high or falsely low testosterone measurements. Inaccurate results may lead to unnecessary follow-up testing or delayed diagnosis.

Moderate·FDA·Jul 22, 2026·Tosoh Bioscience

The Photera 400 ultraviolet phototherapy device uses a sensor to measure and control UV output for treating skin disorders. A calibration error caused the sensor to report incorrect UV levels, which means patients may have received different doses than intended.

Moderate·FDA·Jul 22, 2026·Daavlin3 products

Maquet (now Getinge) identified that 205 units of the Vasoview Hemopro 2 endoscopic vessel harvesting system from a single lot were exposed to an incorrect sterilization dose during gamma sterilization processing. This occurred at a STERIS facility in New Jersey in late March 2026. The affected devices may not be adequately sterilized.

Moderate·FDA·Jul 22, 2026·Maquet

3B Medical is recalling Rio II nasal pillows interfaces due to a packaging and labeling discrepancy affecting product size identification and device identifiers. The affected units have incorrect or mismatched labeling on certain lots, which could lead to patients receiving the wrong size for their CPAP or PAP therapy device.

Moderate·FDA·Jul 22, 2026·3B Medical

Medtronic is recalling two cardiopulmonary bypass cannula products after receiving two complaints of loose foreign material, which was confirmed to contain trace amounts of blood. No injuries have been reported. The recall covers two products and was distributed nationwide in several US states as well as worldwide.

Moderate·FDA·Jul 22, 2026·Medtronic2 products

Medline is recalling two total knee kits, with 163 units of each, because the Zimmer Biomet mixing bowls and spatulas packed inside were recalled for seal problems that could break sterility. Distribution was limited to California and Utah. No injuries have been reported, and the likely health effect is a short delay in surgery while another device is found.

Moderate·FDA·Jul 22, 2026·Medline2 products

Papablic is recalling two models of replacement brush heads because the brush heads may break. No injuries have been reported. About 28,100 packs are included in the recall across both models, which were distributed nationwide.

Moderate·FDA·Jul 22, 2026·Papablic2 products

Orthofix is recalling four MiniRail external fixation devices, 161 units in total, because some units may carry the wrong model number. The M101 and M103 labels may be swapped, and some M122 units may be labeled M111. No injuries have been reported.

Moderate·FDA·Jul 22, 2026·Orthofix4 products

GE HealthCare found that some Optima XR200, XR220, and XR240amx mobile X-ray systems that had a column replacement may not have had their safety pawl tested to confirm proper assembly. If the internal counterpoise cable fails, the column safety mechanism may not work, and the X-ray tube and collimator arm could drop down the column during an exam. The recall covers 66 units across three products. No injuries have been reported.

Moderate·FDA·Jul 22, 2026·GE3 products

Boston Scientific's Rapid Refill Continuous Injection System contains a recalled syringe component that may loosen or disconnect from the device manifold. This could result in fluid leakage, inability to inject or aspirate properly, or complete separation of the syringe, potentially requiring device replacement and extending the procedure.

Moderate·FDA·Jul 22, 2026·Boston Scientific

ICU Medical is recalling two infusion pump products, the Plum Duo and Plum Solo Precision IV Pump, because in a specific scenario the pump may not count down the Volume to be Infused on its Delivery screen and could deliver up to twice the programmed volume at the set rate. The recall covers about 17,584 units distributed across the US and Canada, and no injuries have been reported.

Serious·FDA·Jul 22, 2026·ICU Medical2 products

Arm drapes used with Intuitive Surgical's da Vinci SP robotic surgical system may detach from the instrument arm due to a defect in the drape rings at the top of the product. If a drape detaches during surgery, it can expose part of the instrument arm and may delay the procedure or require switching to an alternative surgical approach.

Moderate·FDA·Jul 22, 2026·Intuitive Surgical

Olympus is recalling four evacuator products, including Toomey and Ellik models, because some sterilization instructions may not reliably make the devices fully sterile. The recall covers about 8,250 units distributed in the US and internationally.

Moderate·FDA·Jul 22, 2026·Olympus4 products

Argon Medical Devices is recalling six procedure trays and kits, including the Transvenous Pacing Electrode Tray, One-Piece Introducer Tray, General Biopsy Tray, T-Lok Bone Marrow Tray, Arterial Line Kit, and Bone Marrow Tray. Some kits contain lidocaine ampules that are already subject to another recall, and the kits did not meet sterility release criteria. No injuries have been reported.

Serious·FDA·Jul 22, 2026·Argon Medical Devices6 products

Abiomed is recalling 13 Impella heart pump sets and introducer kits because the introducer sheath may leak from under the sheath cap and along the hub score lines. The problem affects 14Fr and 23Fr introducers, which come in every pump set, and users cannot see it visually. No injuries have been reported.

Serious·FDA·Jul 22, 2026·Abiomed13 products

Abiomed's Impella Introducer Kit (Hemostatic Peel Away Introducer System) may have manufacturing defects that cause the 14Fr and 23Fr introducer sheaths to leak from multiple locations: the sidearm, under the sheath cap, and along hub seams. This affects 355 units distributed in Massachusetts.

Serious·FDA·Jul 22, 2026·Oscor3 products

Zimmer Biomet is recalling two A.T.S 4000 TS tourniquet system hoses because the sealing area of the sterile pouch may be breached. If used, the hose may cause a moderate, localized infection. If found before use, surgery may be briefly extended while another device is located.

Moderate·FDA·Jul 8, 2026·Zimmer Biomet2 products

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.

Moderate·FDA·Jul 8, 2026·Gore

Masimo is recalling two Radius VSM products: an ECG pre-connected electrode set and disposable blood pressure cuffs, covering 1,800 units in total. The ECG feature may incorrectly flag abnormally slow or fast heart rates in patients with normal rhythms, which could distract clinicians from true alarms and delay treatment. The blood pressure cuffs may have rough edges that can cause skin irritation or redness. No injuries have been reported.

Moderate·FDA·Jul 8, 2026·Masimo Corporation2 products

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.

Moderate·FDA·Jul 8, 2026·Laborie Medical Technologies Corp

Bard Access Systems is recalling 14 products, including PICC, midline, and dialysis catheters and biopsy trays. The recall stems from lidocaine ampoules that were made under deficient manufacturing practices, and the supplier is recalling them. No injuries have been reported.

Moderate·FDA·Jul 8, 2026·Bard14 products

BD Switzerland inadvertently shipped 50 engineering sample units of the Medline 111 Gravity Set with 3 Needle Free Y-Sites into the U.S. market. These units were labeled "Not for Human Use" and were not intended for patient care. No injuries have been reported.

Moderate·FDA·Jul 8, 2026·BD

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.

Moderate·FDA·Jul 8, 2026·Covidien LLC

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.

Moderate·FDA·Jul 8, 2026·Carl Zeiss Meditec

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.

Moderate·FDA·Jul 8, 2026·Siemens

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.

Moderate·FDA·Jul 8, 2026·Raysearch Laboratories2 products

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.

Moderate·FDA·Jul 8, 2026·Medela Inc

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.

Moderate·FDA·Jul 8, 2026·Accuray Incorporated

Siemens is recalling three models of its ARTIS icono imaging systems, 234 units in total, because the detector lift may stop moving after it is adjusted to its highest or lowest height limit. No injuries have been reported.

Moderate·FDA·Jul 8, 2026·Siemens3 products