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Certain Beckman Coulter AU480 Chemistry Analyzers may fail to start due to a software error when the system boots. When this happens, the instrument cannot begin processing patient samples, which delays test results. This affects approximately 492 units distributed worldwide.

Moderate·FDA·Oct 7, 2026

Penumbra Inc. is recalling the Penumbra System RED 62 Reperfusion Catheter due to a manufacturing issue that may cause the catheter to fracture during use. The recall affects 43 units distributed across multiple U.S. states. No injuries have been reported to date.

Moderate·FDA·Oct 7, 2026·Penumbra

A beta version of the Tandem t:slim iOS app (version 2.13) has a software bug that prevents it from connecting to Abbott FreeStyle Libre 3 Plus glucose monitors. Users affected by this issue cannot see their blood sugar readings in the app and cannot use automated insulin delivery; they must switch to manual pump mode instead.

Moderate·FDA·Oct 7, 2026

The Olympus Tripp-Lite P580-025 25ft DisplayPort Cable (Model P580-025) may cause video dropout or blackout when used with the OLYSENSE Hub System in high-power operating mode. About 543 cables were affected and distributed worldwide, including the US and Poland.

Moderate·FDA·Oct 7, 2026

Spectrum Medical is recalling two Quantum PureFlow Standard Heat Exchanger models because a leak can allow blood and glycol to mix inside the heat exchanger. The recall covers 2 products distributed across 19 states, and no injuries have been reported. No remedy has been specified yet.

Moderate·FDA·Oct 7, 2026·Spectrum Medical2 products

Two units of the Micro Therapeutics Pipeline Flex Embolization Device (model PED2-300-12) were distributed with incorrect labeling. The packages were labeled as 3.00 mm diameter, but the devices inside were actually 2.50 mm diameter. This mismatch could lead to incorrect device selection during surgery.

Moderate·FDA·Oct 7, 2026·Micro Therapeutics

Percussionaire is updating labeling for its Intrapulmonary Percussive Ventilation (IPV) devices to warn against using them with volatile anesthetic delivery systems. IPV may change how anesthetic agents are delivered, which could lead to anesthesia that is too deep or too light. This recall includes 7 products, and no injuries have been reported.

Moderate·FDA·Oct 7, 2026·Percussionaire7 products

Philips is recalling 12 MR imaging system products and related upgrades because diffusion tensor imaging (DTI) scans exported in the Enhanced MR DICOM format can contain incorrect diffusion direction data. When that export is used with third-party tractography software, the software may not be able to correctly process the data for reconstruction. No injuries have been reported.

Moderate·FDA·Oct 7, 202612 products

Certain NOxBOXi Nitric Oxide Delivery System units (Model NOXBOX-I) may provide inaccurate oxygen readings due to a manufacturing issue with the oxygen sensors. The affected units are identified by specific serial numbers starting with NI100825 through NI101636.

Moderate·FDA·Oct 7, 2026·Noxbox

Merit Medical Systems is recalling Embosphere microspheres used in tumor and blood vessel procedures. Some units have holes in their packaging that could compromise the sterile barrier, potentially exposing the product to contamination and increasing infection risk if used.

Moderate·FDA·Oct 7, 2026

Heraeus is recalling four PALACOS bone cement product lines, which are pre-filled into mixing and application systems. The company identified a potential for the monomer liquid to leak. No injuries have been reported. The recall was distributed in the US and several other countries.

Moderate·FDA·Oct 7, 2026·Heraeus4 products

Olympus is recalling two models of its M3 Gold autoclavable telescopes, 122 units in total. The sterilization settings in the English Instructions for Use do not match those in the Japanese package insert. The recall covers units distributed only in Japan, and no injuries have been reported.

Moderate·FDA·Oct 7, 20262 products

Cardinal Health is recalling four Presource Pack surgical kits that contain Stryker StrykeFlow PS and AHTO tube sets. The handpieces on these tube sets may leak fluid during use, and the fluid can pool on the floor, creating a slip and fall risk. About 7,000 kits are included, and they were distributed nationwide, including in CA, IL, KY, MO, NC, NY, OH, and TX. No injuries have been reported.

Moderate·FDA·Oct 7, 20264 products

American Contract Systems is recalling three medical convenience kits that contain BD CliniClean Pericare Wipes inside BD Urinary Catheter Trays. The wipes may be contaminated with a lubricant from the manufacturing process, which can cause localized skin irritation. About 1,804 kits of each product were affected, and the kits were distributed in Iowa, Minnesota, Wisconsin, and South Dakota. No injuries have been reported.

Moderate·FDA·Oct 7, 20263 products

American Nitrile Operations is recalling three lines of blue nitrile patient examination gloves, covering 13 catalog numbers. The gloves may have tears, missing fingers, or debris. Defective gloves could expose health care workers and patients to infectious pathogens or chemical agents. No injuries have been reported.

Moderate·FDA·Oct 7, 2026·American Nitrile Operations3 products

United Imaging is recalling 12 models of CT and PET/CT imaging systems because of a software problem. When the Split or Local function is enabled and multiple RIS exams are merged into one study, patient images may not appear in the Patient Administration interface, which may require rescans. No injuries have been reported.

Moderate·FDA·Oct 7, 2026·United Imaging12 products

The Philips IntraSight Plus imaging system software may incorrectly link one patient's images to another patient's medical record. This could lead to wrong diagnosis or treatment if the mix-up goes unnoticed.

Moderate·FDA·Oct 7, 2026·Volcano

The EnCor EnCompass breast biopsy and tissue removal system console and driver may experience probe calibration failures or pressure sensor errors during use. When these errors occur, the system prompts the user to restart and recalibrate, which can interrupt the biopsy procedure, prolong it, or require additional tissue sampling or a repeat biopsy.

Moderate·FDA·Oct 7, 2026

Alere is recalling four groups of hCG rapid tests, which detect the pregnancy hormone hCG, because they may pick up very low hCG levels below the stated sensitivity. This can lead to a false positive result. No injuries have been reported, and the tests were sold across the U.S. and in several other countries.

Moderate·FDA·Oct 7, 2026·Alere4 products

Draeger has recalled its VentStar Resus Neo neonatal breathing circuit (Part Number MP00310) due to potential cracks in the hose. These cracks could cause air leakage or allow the hose to separate during use. The recall affects all lot numbers distributed nationwide and internationally.

Serious·FDA·Oct 7, 2026

Medline is recalling two products: hand control pendants and their wiring used with certain home care beds. The pendant or its wiring can overheat, which may cause smoking, sparking, melting, burning, or fire. About 771,127 units are affected, and the recall was expanded on 11/26/2025 to add products.

Serious·FDA·Oct 7, 20262 products

The bolus tracking application on Philips Spectral CT 7500 scanners (Software V5.2.x) can malfunction and continue taking imaging shots even after reaching the contrast threshold. This can cause patients to receive unintended additional radiation during CT scans.

Moderate·FDA·Oct 7, 2026

Illumina has issued a retrospective correction for certain NovaSeq 6000Dx and DRAGEN Server instruments used in genetic testing. These devices contain a security vulnerability in the server component that could potentially allow unauthorized access. This affects 80 instruments distributed worldwide.

Moderate·FDA·Oct 7, 2026·Illumina

Mastisol Skin Adhesive, a sterile surgical glue used in regional anesthesia procedures, is being recalled due to manufacturing issues with the product contained in surgical convenience trays. The recall affects a specific lot used in continuous epidural trays distributed nationwide.

Moderate·FDA·Oct 7, 2026·Custom Interventional Pain Management

ASP Global is recalling 64 Expressaire disposable tourniquet cuffs made between September 2016 and March 2023. The labels list a 10-year shelf life, but the validated shelf life is 5 years, so the printed expiration dates are wrong. No injuries have been reported.

Moderate·FDA·Oct 7, 2026·ASP Global64 products

A batch of benzoyl peroxide wash distributed by Rugby Laboratories has been found to contain microbial contamination. The affected product is a 5% benzoyl peroxide topical wash in a 5 fl oz bottle, lot #0525-02-345, expiring 02/2027, distributed in Illinois only.

Moderate·FDA·Oct 7, 2026·SV Labs2 products

Apotex Corp. is recalling Paroxetine Extended-Release Tablets 37.5mg (Lot# TY9495, Exp Date 05/2027) because they failed to meet dissolution specifications. This means the tablets may not break down properly in the body, affecting how much medicine is absorbed.

Moderate·FDA·Oct 7, 2026

Par Health USA and Endo USA are recalling certain lots of Buprenorphine Hydrochloride 0.3 mg/mL injection due to crystallization in the vials. Crystallization can affect the drug's effectiveness and safety. The recall affects six specific lots distributed nationwide.

Moderate·FDA·Oct 7, 2026

A shipment of Zoladex (goserelin) 3.6 mg implants was left in an unheated FedEx trailer in outdoor conditions for approximately 25.5 hours. This temperature exposure may have affected the medication's stability and effectiveness. The recall affects 296 cartons with lot number YN0099 (expiration 01/31/2028).

Moderate·FDA·Oct 7, 2026·TerSera Therapeutics

Amneal Pharmaceuticals is recalling specific lots of Estradiol Gel 0.1% because some packets in affected cartons were found to be empty or only partially filled. This means patients may not receive the correct dose of medication. The recall affects 2,592 cartons distributed nationwide.

Moderate·FDA·Oct 7, 2026