Medical device recalls

HeartSine Technologies has recalled certain models of the SAM 350P, SAM 360P, and SAM 450P public access defibrillators (PADs) due to a damaged membrane component that can cause an intermittent electrical fault. The fault could prevent the device from operating properly when needed in a cardiac emergency. Approximately 11,912 affected units have been identified by serial number.

Serious·FDA·Sep 16, 2026·HeartSine

Bard is recalling six Foley and intermittent catheter tray products because the pericare wipes packed with them may have contamination on their surface. The recall followed customer complaints, and no injuries have been reported. The trays were distributed across the United States and in several other countries.

Moderate·FDA·Sep 16, 2026·Bard6 products

Atrium Medical is recalling three Getinge PVC thoracic catheter products, covering 11 model sizes, from a single lot. Testing found bacterial endotoxin levels above the allowed limit. No injuries have been reported.

Moderate·FDA·Sep 16, 2026·Atrium Medical3 products

Lutronic's DermaV laser system may produce sparks and loud noise when used at higher energy levels (fluences) at the 1064 nm wavelength with current cooling settings. This spark hazard could result in patient burns during treatment.

Moderate·FDA·Sep 16, 2026·Lutronic

Halyard IV Start Kit Non-Sterile (REF: KRIV26-02) convenience kits contain BD ChloraPrep Clear and FREPP Clear applicators with wrinkles in the paper lidding that may breach the seal. This compromises sterility assurance of the applicators. 98 kits in lot 1658438 (expiration 7/31/2026) were distributed nationally.

Moderate·FDA·Sep 16, 2026·AVID MedicalExpanded Sep 30

Medical Action Industries is recalling two epidural kit products, 5,566 units in total. The kits contain saline ampules that are part of a separate recall, and the kits may not be sterile. No injuries have been reported.

Serious·FDA·Sep 16, 2026·Medical Action Industries2 products

The Bravo CF capsule delivery device is used during esophageal pH monitoring procedures to attach a small capsule to the esophagus. The capsule may fail to attach properly or detach from the delivery device during use. This can result in the capsule being inhaled, perforating the esophagus, blocking the airway, or causing bleeding.

Serious·FDA·Sep 16, 2026·Given Imaging

Cardinal Health is recalling 12 procedure kits that include BD Urinary Catheter Trays with CliniClean Pericare Wipes. The wipes may be contaminated with a lubricant used during manufacturing. If a contaminated wipe is used on a patient, it may cause localized skin irritation, redness, or mild inflammation. No injuries have been reported.

Moderate·FDA·Sep 9, 2026·Cardinal Health12 products

Fresenius Medical Care is recalling three dialysis acid concentrate products, GRANUFLO, NaturaLyte and Citrasate, after complaints of blue-green discoloration in the product. No injuries have been reported. The products were distributed nationwide in the US and in Mexico.

Moderate·FDA·Sep 9, 2026·Fresenius Medical Care3 products

Specific lots of B Braun's Discofix Four Way Stopcock extension sets have an incorrect expiration date printed on the carton shipper label. This labeling error could affect proper product tracking and usage verification.

Moderate·FDA·Sep 9, 2026·B. Braun

A software issue in the robotic controller of the Medos Velys Enabling Tech Robotic-Assist Station may cause the robotic arm to move unexpectedly during bone preparation or instrument positioning in orthopedic surgery. This affects 29 devices nationwide.

Moderate·FDA·Sep 9, 2026·Medos

Fresenius Medical Care is recalling four 5008X blood tubing set models because the connection between the Arterial Alpha Clip and the main line or pump segment may leak blood during treatment. A leak could cause blood loss and low blood volume. No injuries have been reported.

Moderate·FDA·Sep 9, 2026·Fresenius Medical Care4 products

Boston Scientific is recalling server software that supports its LUX-Dx, LUX-Dx II, and LUX-Dx II+ insertable cardiac monitors. The recall covers three products, one for each region: US, EU, and ANZ. The software can delay notifications of AF Burden Alerts, which are alerts about atrial fibrillation, and a delayed alert may delay clinical review or treatment. No injuries have been reported.

Moderate·FDA·Sep 9, 2026·Boston Scientific3 products

Medline is recalling 13 convenience kits that contain BD ChloraPrep Clear 1mL applicators from specific lots. The applicator packaging may have an open or incomplete seal, so the applicator could be contaminated. Contaminated applicators can cause skin or soft tissue infections, or more serious infections, and no injuries have been reported.

Moderate·FDA·Sep 9, 2026·Medline13 products

Baxter is recalling two Novum IQ syringe pump models, totaling about 14,605 units. During a Volume/Time (VOT) multi-syringe infusion, a software issue may occur if a syringe runs empty and is replaced while the Volume To Be Infused (VTBI) is still remaining. No injuries have been reported.

Moderate·FDA·Sep 9, 2026·Baxter2 products

Johnson & Johnson is sending updated surgical instructions for HEALON EndoCoat PRO and HEALON DUET PRO II viscoelastic products used in cataract surgery. The new instructions emphasize that if resistance is felt when inserting the cannula, surgeons should stop, withdraw the cannula, and reassess insertion conditions rather than forcing it—to avoid potential injury to the cornea, iris, or Descemet's membrane (a delicate eye structure).

Moderate·FDA·Sep 9, 2026·Johnson & Johnson Surgical Vision

Medline is recalling 16 convenience kit products that contain BD ChloraPrep Clear or FREPP Clear antiseptic applicators. Wrinkles in the paper lidding may extend to the seal, which could break the sterile packaging and allow microbial contamination. No injuries have been reported.

Moderate·FDA·Sep 9, 2026·Medline16 products

Diagnostica Stago identified a positive drift in quality control (QC) values in one lot of STA Staclot Protein S reagent within the product's stated 4-hour stability period. This drift could affect the accuracy of test results performed during that window. The issue affects reagent Lot 273074 distributed nationwide.

Moderate·FDA·Sep 9, 2026·Diagnostica Stago

Medicom is recalling specific lots of Ritmed Neurological Sponges (non-sterile models 55992C to 55998C) because their endotoxin levels may vary unexpectedly. AVID Medical is recalling three groups of Halyard medical convenience kits that contain these sponges, about 28,800 kits in total. No injuries have been reported.

Moderate·FDA·Sep 9, 2026·AVID Medical3 products

Philips is recalling four CT scanner product lines, covering 4 product groups, because an unintended radiation issue could affect how the equipment performs. The recall covers Philips Brilliance, IQon Spectral CT, Ingenuity CT, and Brilliance CT 64 systems distributed in the US and US territories. No injuries have been reported.

Moderate·FDA·Sep 9, 2026·Philips4 products

GE is recalling four Portrait Core Services software products because a software issue may cause a loss of patient monitoring at the Hub and Central Viewer. After the update, alarm settings may also reset to factory defaults and no longer match the settings configured for each patient or care area. No injuries have been reported.

Serious·FDA·Sep 2, 2026·GE4 products

Olympus Corporation of the Americas is recalling POWERSEAL 5mm curved jaw sealer and divider devices due to incorrect labeling on the outer box. Some units labeled as 37 cm devices actually contain 23 cm devices, which could lead to confusion during surgical use. The issue affects 335 units distributed in the US, Australia, the European Union, and Japan.

Moderate·FDA·Sep 2, 2026·Olympus

IMRIS is recalling 2 operating room table models, the ORT200 and ORT300, with 19 affected units. A mechanical failure in the linear actuator and rotational lock can stop the table from switching between locked and unlocked, which could allow unintended rotation during a procedure. No injuries have been reported.

Serious·FDA·Sep 2, 2026·IMRIS2 products

Healthmark Industries is recalling two ProChek protein test products, 5,143 units in total. The tests were made with an expired ingredient, so they may give false negative or false positive results. No injuries have been reported.

Moderate·FDA·Sep 2, 2026·Healthmark Industries2 products

FUJIFILM Synapse PACS software version 7.4.310, used in radiological imaging systems, has a software issue that can cause the ruler measurement tool to display inaccurate values. This affects 6 units distributed across select US states and Australia. No injuries have been reported.

Moderate·FDA·Sep 2, 2026·Fujifilm

Medline is recalling 11 groups of surgical convenience kits. The kits contain a component that the manufacturer recalled because it may be contaminated. No injuries have been reported, and the kits were distributed in 18 states.

Moderate·FDA·Sep 2, 2026·Medline11 products

Some ConMed Linvatec GENESYS CrossFT Suture Anchors (REF# CFBC-5502B, Lot 1513167) may contain an incorrect patient implant card. This card is used to identify and track the device after implantation, so an incorrect card could lead to confusion about which device was used.

Moderate·FDA·Sep 2, 2026·ConMed

Fresenius Medical Care has identified a problem with certain 2008T BlueStar hemodialysis machines that can cause flow, water supply, or temperature alarms to malfunction. These alarms are important safety features that alert clinical staff to problems during treatment. About 1,140 affected machines have been identified by serial number.

Moderate·FDA·Sep 2, 2026·Fresenius Medical Care

Henry Schein is recalling two dental restorative products, Structur 2 SC Temporary Resin Cartridge Refill and Grandio Universal Nano-Hybrid Restorative Material Capsules, with 974 units affected. Specific lots were distributed in the U.S. and Barbados with incorrect packaging and Instructions for Use from the FDA-cleared device.

Moderate·FDA·Sep 2, 2026·Henry Schein2 products

Fixing screws on the ceiling movement gear of the suspended arm in Canon Medical Alphenix interventional X-ray systems may become loose over time. This could potentially cause the arm to shift during use. Ten systems are affected across eight U.S. states.

Moderate·FDA·Sep 2, 2026·Canon