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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

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

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, 20263 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

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

Kwok Shing American Ginseng products (4 oz and 8 oz packages) may be contaminated with pesticides. The contamination was identified during testing, and 70 boxes have been affected.

Moderate·FDA·Sep 30, 2026·Kwok Shing

Prestige Consumer Healthcare is recalling 2 products, both Clear Eyes Redness Relief lubricant and redness reliever eye drops in 0.5 fl oz (15 mL) bottles, one sold with a hang tag. The company cannot assure the drops are sterile. No injuries have been reported, and about 2.4 million bottles were affected.

Moderate·FDA·Sep 30, 2026·Prestige Consumer Healthcare2 products

Some prefilled pens of Amneal Exenatide Injection may contain no medication due to a defective delivery system. This affects lot AP250095A (expiration 2/28/2027). Patients relying on these pens may not receive their intended dose.

Moderate·FDA·Sep 30, 2026

Macleods Pharmaceuticals has recalled Olanzapine Tablets USP 5 mg (lot BOB22321A, expiring 07-31-2027) because testing found organic impurities above acceptable limits. The affected bottles were distributed nationwide. No injuries have been reported.

Moderate·FDA·Sep 30, 2026

The FDA has announced a nationwide recall of 9 lubricant eye drops and one eye ointment sold under the Walgreens, AvKare, Reliable-1 Laboratories, TRP Gentle Eyes, Major LubriFresh P.M. and Cameron Pharmaceuticals names. The manufacturer could not confirm that the products are sterile, which is required for eye products. No injuries have been reported.

Moderate·FDA·Sep 30, 2026·Sterling Pharmaceutical Services9 products

MENOW Sunscreen Pressed Powder SPF35 PA+++ was manufactured in ways that do not meet U.S. cosmetic manufacturing standards (cGMP deviations). The affected product was distributed in California only. No injuries have been reported.

Moderate·FDA·Sep 30, 2026·Shantou Qiwei

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

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

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, 20264 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, 202612 products

The tension bolt in certain Mirion Captus 4000e thyroid imaging systems can fail, allowing the spring arm to unexpectedly drop to its lowest position, about 25 inches from the ground. This affects specific models shipped between April 2019 and February 2024 that have not yet received the redesigned arm. No injuries have been reported.

Moderate·FDA·Sep 23, 2026·Mirion Technologies

Certain Datex-Ohmeda Aisys CS2 anesthesia systems with specific electronic gas mixer assemblies can automatically switch to a backup oxygen-only mode. When this happens, the delivery of anesthetic medication stops, and the system triggers alarms. A clinician must manually intervene to restore anesthetic delivery, or the patient may not receive adequate anesthesia.

Moderate·FDA·Sep 23, 2026·Datex-Ohmeda4 products

Certain power adapters used with the StoneSmart Connect Console may have higher-than-expected electrical resistance in the grounding path. These adapters may fail electrical safety testing during installation, which could affect device safety.

Moderate·FDA·Sep 23, 2026

Stryker is recalling six Ethicon XCEL bladeless trocar products, which are reusable surgical access port systems. The ports may crack or separate during use. No injuries have been reported.

Moderate·FDA·Sep 23, 20266 products

Blood culture collection kits made by Medical Action Industries contain BD ChloraPrep applicators with potentially open or incomplete seals on their packaging. This compromised seal may allow contamination, and use of affected applicators could result in localized skin or soft tissue infection.

Moderate·FDA·Sep 23, 2026

Embecta is recalling two lines of pen needles that were labeled 'For Investigational Use Only' but were sent out as regular commercially sold devices. The recall covers 7,300 units across two products, shipped nationwide to 22 states. No injuries have been reported.

Moderate·FDA·Sep 23, 2026·Embecta2 products

Two Kinos Axiom Total Ankle System units were packaged with incorrect patient-specific cutting guides. Using the wrong guides during surgery could lead to poor implant alignment, loose implants, or the need for revision surgery.

Moderate·FDA·Sep 23, 2026

Wilson-Cook Medical's Hemospray endoscopic hemostat devices may fail to spray powder properly or stick to the endoscope during use. The manufacturer is issuing updated instructions to address these operational issues.

Moderate·FDA·Sep 23, 2026

Straumann USA LLC is recalling the GM Helix Implant (REF 109.984) because the product label on the packaging does not match the actual dimensions of the implant inside. This mismatch could lead to use of an incorrect implant size during dental procedures. The affected lot (VZPF4) was distributed nationwide to dental providers.

Moderate·FDA·Sep 23, 2026

The 6Fr suction catheter may not pass smoothly through certain SunMed Tracheal Tube Size 2.5 samples (Model 1-7333-25), creating a potential obstruction during use. This issue affects multiple lot numbers distributed nationwide.

Moderate·FDA·Sep 23, 2026·Well Lead

GE Healthcare's Centricity PACS imaging software can sometimes link historical medical images to the wrong patient when data is moved from older systems. If this happens, a doctor might see one patient's scans under another patient's record, potentially leading to wrong diagnoses or delayed care.

Moderate·FDA·Sep 23, 20266 products

The oxygen tubing in certain NOxBOXi Nitric Oxide Delivery Systems may leak or disconnect, which could reduce oxygen flow to the patient. This happens because the tubing or its connection can fail. The recall affects 1,547 units with specific serial numbers.

Moderate·FDA·Sep 23, 2026·Noxbox

Nuclein LLC is recalling specific units of the DASH Rapid PCR Instrument due to a software issue in versions 6.0.2, 6.0.4, 6.0.5, and 6.0.6. The affected instruments are used in clinical laboratories to detect infectious diseases through rapid PCR testing. The software problem may impact the accuracy or reliability of test results.

Moderate·FDA·Sep 23, 2026·Nuclein

ICU Medical is recalling eight IV administration sets with drip chambers. The drip chambers may have black specks, which may come from discolored plastic left behind during manufacturing. The company has not ruled out discoloration or particles in the fluid path. No injuries have been reported.

Moderate·FDA·Sep 23, 20268 products