Medical device recalls

Baxter is recalling three PRO+ MRS mattress surface products, 999 units in total, because the product description on the Unique Device Identification (UDI) label contains errors. The mismatched labels could lead to incorrect product identification or selection, potentially resulting in use with an incompatible bed frame. No injuries have been reported.

Moderate·FDA·Sep 30, 2026·Baxter3 products

Halyard IV START KIT NON-STERILE kits containing BD ChloraPrep Clear applicators may have open or incomplete seals on the applicator packaging. This affects 192 kits (4 cases) with lot number 1642214 and expiration date 7/31/2027. No injuries have been reported.

Moderate·FDA·Sep 30, 2026·AVID Medical

New York Embroidery Studio's Trinity Non-Surgical Isolation Gown (Model NYES100-2, X-Large) does not consistently provide the liquid-barrier protection it should. This means the gown may allow fluids to pass through when it should block them, potentially exposing the wearer.

Moderate·FDA·Sep 30, 2026·New York Embroidery Studio

Intervascular's Cardioroot Woven Collagen Coated Vascular Graft failed to meet water permeability specifications in certain batches. The graft is a surgical implant used in vascular procedures. Approximately 16,329 units distributed worldwide are affected.

Moderate·FDA·Sep 30, 2026·Intervascular

During manufacturing quality testing, contamination in Baxter's test equipment may have affected the accuracy of nebulizer flow rate measurements on two VOLARA Homecare devices. The company has retrieved the affected units and retested them; both met specifications.

Moderate·FDA·Sep 30, 2026·Baxter

DeRoyal Industries myocardial temperature probes (400 Series, Lot #63426754) contain an 18mm needle instead of the correct 15mm needle. This mismatch could affect proper placement and function during cardiac temperature monitoring.

Moderate·FDA·Sep 30, 2026·DeRoyal

Cardinal Health is recalling 2 groups of Presource Convenience Kits, totaling about 26,983 kits, because the applicators inside may have an open or incomplete seal on their packaging. A possibly contaminated applicator could cause no harm, or could lead to a localized skin or soft tissue infection, and less commonly a more widespread infection. The kits were distributed nationwide, with the recall covering stock sent to FL, KY, MO, NC, OH, and TX, and no injuries have been reported.

Moderate·FDA·Sep 30, 2026·Cardinal Health2 products

Some Criticare nGenuity Patient Monitors with CO2 monitoring display a "Checkline Error" alarm during setup, which disables the CO2 monitoring function. This may delay medical procedures that rely on this monitoring capability.

Moderate·FDA·Sep 30, 2026·Criticare

Abiomed has issued a retrospective recall of certain Automated Impella Controller (AIC) units manufactured before 2019. The devices contain firmware and software defects that can affect the accuracy of pressure signals, cause unreliable placement detection, and trigger false alarms. These issues were remedied through firmware and software patches released in 2019.

Moderate·FDA·Sep 30, 2026·Abiomed

Becton Dickinson has recalled certain ForeSight Elite tissue oximetry cables due to incorrect labeling of Channel 1 and Channel 2 on the module and flag labels. This labeling error could cause clinicians to misread oxygen saturation data if the cables are connected to the wrong channels. The affected cables were distributed to hospitals and healthcare facilities.

Moderate·FDA·Sep 30, 2026·Becton Dickinson

A software issue in Philips EPIQ Elite ultrasound systems (Model 795234, software version 14.0) causes doppler blood flow measurements to display at incorrect depths. This can lead to inaccurate velocity readings and potential misdiagnosis of vascular conditions. About 219 units are affected worldwide.

Moderate·FDA·Sep 30, 2026·Philips

A small number of Pearle Vision 1 day contact lenses in one affected lot were manufactured with incorrect lens power. This could result in blurred or distorted vision if the wrong lens is worn. No injuries have been reported.

Moderate·FDA·Sep 30, 2026·CooperVision

Olympus is recalling four BiCOAG Hemostasis Probe models because they may have been made without the full amount of adhesive, so the ceramic tip could detach. The recall covers 3,467 units sold in the US and several other countries. No injuries have been reported.

Moderate·FDA·Sep 30, 2026·Olympus4 products

Philips is recalling 12 groups of MRI systems and related upgrade products because of a software issue. If scan settings are manually adjusted so the image processing needs more memory than the system has, the examination can end partway through. No injuries have been reported.

Moderate·FDA·Sep 30, 2026·Philips12 products

Some units of the Biomerieux VITEK 2 AST-N461 test kit used to determine antibiotic susceptibility in gram-negative bacteria have damaged card pouches. This damage can cause the test to report false resistant results, which may lead to use of less effective antibiotics or unnecessary antibiotic combinations.

Moderate·FDA·Sep 30, 2026·bioMérieux

Medline convenience kits (models DYNJ48258D and DYNJ48258F) contain Healthmark Instrument Channel Brushes with a potential sharp edge or burr on the brush end. This sharp edge could cause a cut, abrasion, or infection if the brush is handled or used.

Moderate·FDA·Sep 30, 2026·Medline2 products

SeaSpine Orthopedics is recalling certain Extended Polyaxial Head spinal implants (model MD1-300010-12) because the proximal thread depth does not meet design specifications. This defect could affect the secure attachment of the device during spinal surgery. No injuries have been reported.

Moderate·FDA·Sep 30, 2026·SeaSpine

Fresenius Medical Care is issuing a communication regarding its CombiSet hemodialysis blood tubing set (Model 03-2522-1) to ensure healthcare providers and patients review the product's instructions for use. The company is recommending that all treatment preparation and handling steps be performed exactly as instructed to maintain safe operation.

Moderate·FDA·Sep 30, 2026·Fresenius Medical Care

Maquet PowerLED 300 concealed lighting systems may detach at the connection between the spring arm and suspension arm. This could cause the device to fall and potentially injure someone in an operating room or clinical setting.

Moderate·FDA·Sep 30, 2026·Maquet

Ventec Life Systems is recalling three HomeFill oxygen cylinder products, 48 units in total. The cylinders do not have the medical gas labeling required by regulators. No injuries have been reported. The recall covers units distributed in Florida, Iowa, Ohio, Nebraska, and Tennessee.

Moderate·FDA·Sep 30, 2026·Ventec Life Systems3 products

Midmark Corporation's IQvitals Zone vital signs monitor may display inaccurate blood pressure readings when using the Linear Deflation Method. This affects Model 1-200-0320 with Kit 4-000-0622. The device measures blood pressure, pulse, temperature, and oxygen saturation for adult and pediatric patients.

Moderate·FDA·Sep 30, 2026·Midmark4 products

Some Olympus EZDilate Endoscopic Balloon Dilator devices (Model BD-420X-1355) have an incorrect label on the shaft. The inflation chart label may show balloon sizes of 18, 19, or 20 mm when the actual device is 11, 12, or 13 mm. This mislabeling could lead to confusion during use.

Moderate·FDA·Sep 30, 2026·Olympus

The wheels on Heidelberg Engineering's SPECTRALIS imaging device may come loose when the module is pushed or pulled during movement or transportation. If wheels loosen, the stand can become unstable and tip over, potentially causing impact or crushing injuries to nearby people.

Moderate·FDA·Sep 30, 2026·Heidelberg Engineering

The tip of certain Boston Scientific Imager II Angiographic Catheters may fracture or detach during use. Fragments could remain in the patient's body or travel through blood vessels, potentially causing a prolonged procedure or life-threatening blood clot.

Serious·FDA·Sep 30, 2026·Boston Scientific

CooperSurgical is recalling two INCA infant nasal CPAP product lines, 2,792 boxes (13,960 units) in total, because the flexible tubing may loosen from the nasal cannula during assembly or use. A loose connection can cause a loss of CPAP pressure, which may reduce treatment effectiveness and lower oxygen levels until the connection is restored. No injuries have been reported.

Serious·FDA·Sep 30, 2026·CooperSurgical2 products

Pi-Cardia Inc. identified a weld issue in the ShortCut transfemoral catheter that may cause the positioning arm to detach during use. The defect affects 46 units in specific serial number lots distributed across eight U.S. states. No injuries have been reported to date.

Moderate·FDA·Sep 23, 2026·PI Cardia

ICU Medical's CADD Yellow Medication Cassette Reservoirs may leak medication at the connection point between the luer connector and tubing. This leakage could delay or stop medication delivery, reduce the amount of medication received, expose patients to contamination, or allow air to enter the bloodstream.

Serious·FDA·Sep 23, 2026·ICU Medical

Reign Medical's Clench Staple System (Compression) was distributed without adequate performance testing and requires additional FDA clearance. The device is used in bone fixation procedures. About 600 units were distributed nationwide.

Moderate·FDA·Sep 23, 2026·Foundation Medicine

Medline is recalling four convenience kit products because some kits may have open seals in their sterile pouch packaging. An open seal may compromise sterility, which could lead to contamination of a sterile field or patient infection if the kit is used. The recall covers 1,196 affected units distributed nationwide, with distribution listed in Arkansas, Florida, North Carolina, Maryland, and Texas.

Moderate·FDA·Sep 23, 2026·Medline4 products

Howmedica Osteonics is recalling 12 orthopaedic implant components made from polyethylene material that was aged more than five years before use. The aged material may oxidize, which can increase wear and lead to wear debris, fractured or dislodged parts, and may require revision surgery. No injuries have been reported.

Moderate·FDA·Sep 23, 2026·Howmedica Osteonics12 products