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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

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

Datex-Ohmeda is recalling four anesthesia system products, with 1,032 units affected. Certain gas mixer assemblies can automatically switch the system to Alternate O2 control, which delivers 100% oxygen and interrupts anesthetic agent delivery until a clinician intervenes. If that does not happen, the patient may experience decreased anesthetic effect. No injuries have been reported.

Serious·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

Happiest Baby has distributed extra-small and extra-large sizes of the SNOO Sleep Sack without FDA safety and effectiveness review. These sizes were not cleared through the required regulatory process before being sold.

Moderate·FDA·Sep 23, 2026·Happiest Baby2 products

The VERIQA RT MonteCarlo 3D v3 radiation therapy planning software includes bolus (a material placed on the skin to modify radiation dose) in dose calculations, but does not clearly display that the bolus is accounted for. This may cause treatment staff to accidentally skip the bolus during treatment, leading to radiation being delivered to the wrong tissue depth.

Moderate·FDA·Sep 23, 2026·PTW Freiburg

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 is recalling six medical imaging and archive software products, with about 4,000 systems affected. Under certain conditions, historical imaging data moved from an older system can be linked to the wrong patient, so studies or images may appear in another patient's record. No injuries have been reported.

Serious·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

AVID Medical is recalling four Haylard procedure kits, about 2,300 in total, over possible product quality and sterility problems. The kits contain sodium chloride ampules that are also being recalled by Spectra Medical. The kits were distributed in Illinois, North Carolina, Virginia, and Wyoming, and no injuries have been reported.

Serious·FDA·Sep 23, 20264 products

Abiomed is recalling three groups of Impella controllers, about 10,750 units in total, that are used with heart pump systems. A component in the purge pressure sensor assembly, the purge flag, can fail, which may stop the controller from correctly recognizing the purge cassette. No injuries have been reported.

Serious·FDA·Sep 23, 20263 products

Bayer Medical Care has recalled MEDRAD Stellant FLEX Syringe Kits (catalog number FLEXS-150-QFT) used with the Stellant FLEX CT Injection System because some devices may not have been properly sterilized during manufacturing. The recall affects approximately 27,800 kits across the United States.

Moderate·FDA·Sep 23, 2026·Bayer

Maquet is recalling three Percutaneous Insertion Kit products because the packaging may not consistently maintain the sterile barrier. No injuries have been reported. About 271,000 units were distributed in the US and many other countries.

Moderate·FDA·Sep 23, 20263 products

GE's Carescape Central Station patient monitoring system may take up to 3 minutes to resume monitoring after a restart. During this gap, clinically important changes in a patient's condition might not be detected right away.

Moderate·FDA·Sep 23, 2026

Philips is recalling two patient information system products because a software malfunction can cause the system to freeze and stop responding. The recall includes 7,671 affected units across the two products, which were distributed in the US and internationally. No injuries have been reported.

Moderate·FDA·Sep 23, 20262 products

Medline's Open Heart Convenience Kit (DYNJ43008N) contains a coronary cannula with a potential sterile barrier breach. If a compromised pouch seal isn't caught before use, the non-sterile device could cause infection or serious complications including blood cell breakdown, blood clots, or organ damage.

Serious·FDA·Sep 23, 2026

Nova Biomedical is recalling five StatStrip glucose meter models, about 44,400 units in total. A software timing issue can cause a meter to keep the previous patient's or control solution's barcode on screen, so a glucose result may be recorded under the wrong patient. The glucose measurements themselves are not affected, and no injuries have been reported.

Serious·FDA·Sep 23, 2026·Nova Biomedical5 products

Medline is recalling seven groups of convenience kits because certain lots of sterile applicators may contain fungus (Aspergillus penicillioides). Skin preparation products contaminated with this fungus can cause serious infections, including sepsis, and death. The kits were distributed nationwide, and the FDA has classified this as a Class I recall, its most serious category.

Serious·FDA·Sep 23, 20267 products