FDA medical device recalls

Medline discovered that bandage packages may have open seals, which can allow bacteria and germs to contaminate the sterile bandages inside. This affects all lots of CURAD Touch-Free and Quick-Strip Bandages in the 0.75" x 3" size. No injuries have been reported so far.

Cardinal Health ChemoPlus protective gowns and sleeves have been mislabeled with a five-year shelf life when the actual shelf life is three years. The affected gowns may be used past their true expiration date if the incorrect label is relied upon. No injuries have been reported.

Orthofix has recalled certain CONSTRUX Mini Ti Spacer System units used in spine surgery because the product labeling contains claims that are not consistently present across all units. This is a labeling discrepancy issue with no reported injuries.

Orthofix U.S. LLC is recalling multiple models of the Forza Ti Spacer System because the product labeling contains claims that are not consistently present across all units. This is a labeling issue that may affect product identification and use.

Orthofix U.S. LLC is recalling FIREBIRD SI Fusion System screws (multiple sizes, catalog numbers 18-1025SP through 18-2070SP) because the product labeling contains claims that are not consistently present across all units. The issue affects 19,431 screws distributed nationwide and internationally.

Orthofix U.S. LLC is recalling multiple models of the Pillar SA PTC Spacer System because the product labeling contains claims that are not consistently present across all units. This is a labeling issue affecting the information provided with the device.

Orthofix U.S. LLC is recalling FORZA PTC Spacer System devices because the product labeling contains claims that are not consistently present across all units. This is a labeling issue, not a defect in the device itself.

Orthofix U.S. LLC is recalling multiple models of the CONSTRUX Mini PTC Spacer System because the product labeling contains claims that are not consistently presented across all units. This is a labeling issue only; no injuries have been reported.

Waldemar Link knee fusion nails in certain lots were shipped with a locking screw installed incorrectly—inserted from the wrong side into the femoral component. This misalignment could affect how the device functions after implantation. Eighteen units were distributed to Alabama, Georgia, and Texas.

Certain lots of Beckman Coulter Access 2 Reaction Vessels contain small defects on the bottom that may cause errors in laboratory immunoassay instruments. These defects could delay patient test results. The recall affects specific lot numbers distributed nationwide and globally.

Bard Peripheral Vascular Inc. is recalling Safe-T-Centesis 6 Fr Catheter Drainage Trays because the safety indicator on the catheter may show the wrong position—displaying "sharp" when the catheter is actually "blunt." This could lead medical staff to believe the catheter hasn't entered the body cavity when it actually has, potentially causing discomfort, treatment delays, or injury to organs or blood vessels.

Medline is recalling specific batches of Medline Perfusion Syringes (model DYNJ39223C) that contain BD Luer Tip Caps. BD's testing found that certain tip cap trays failed biocompatibility tests, meaning the plastic may cause skin irritation, allergic reactions, or other adverse effects if it contacts patients during use. No injuries have been reported so far.

Some GE Senographe Pristina, Pristina Serena, and Pristina Serena 3D mammography systems were distributed with a missing or incorrect X-ray warning label. This label is required by federal regulation to inform users of radiation hazards. No injuries have been reported.

Between July 2024 and June 2025, some Philips Azurion R3.0 fluoroscopic X-ray systems (model 722234) were shipped without a required safety spacer. This spacer ensures the X-ray tube maintains a safe distance from patients during standard fluoroscopy procedures, as required by FDA regulations.

Draeger airway connectors (model MP01860) used in mechanical ventilation systems have developed cracks in the hose. These connectors deliver breathing gases to patients on ventilators. The cracks could potentially interrupt gas delivery.

Draeger's ErgoStar CM 55 airway connectors (Model MP01855) have developed cracks in the hose under use. These connectors deliver oxygen and other gases to mechanically ventilated patients. The defect affects all lot numbers of this device worldwide.

Draeger's ErgoStar CM 45 airway connectors (Model MP01845) have developed cracks in the hose in certain units. These connectors are used to deliver breathing gases to patients on mechanical ventilators. The cracks could disrupt proper airflow during critical respiratory support.

Draeger's ErgoStar CM 40 airway connectors (model MP01840) have developed cracks in the hose during use. This connector is used in breathing systems for mechanically ventilated patients. Multiple complaints have been reported worldwide, and all lot numbers are affected.

An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits including flow cells that have flow cell gaskets that have a quality issue, which may lead to flow cell leaks during runs, which could cause run failures, that may result in: No/insufficient data output, instrument fluidics clogs, toxic substance exposure to user.

Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.

If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger.

If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger.

Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling.

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.

Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.