New York recalls

Certain Datex-Ohmeda Aisys CS2 anesthesia systems can unexpectedly switch to a backup oxygen-only mode, stopping anesthetic agent delivery. The system triggers alarms when this occurs, but if clinicians do not respond quickly, patients may not receive adequate anesthesia.

Certain Datex-Ohmeda Aisys anesthesia systems may automatically switch to a backup oxygen-only mode, which stops anesthetic agent delivery to the patient. The system will alert staff with audible and visual alarms when this occurs. If staff do not quickly intervene, the patient may not receive adequate anesthesia during the procedure.

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.

Ethicon Endo-Surgery's XCEL Bladeless Trocar with Stability Sleeve (5×75 mm) may crack or separate during surgical use. The reusable access port system in affected lots could fail during a procedure.

The reusable access port system in this surgical trocar may crack or separate during use. This affects specific lot numbers manufactured by Ethicon Endo-Surgery, Inc. and distributed by Stryker Sustainability Solutions.

Ethicon Endo-Surgery's Xcel Bladeless Trocar with Stability Sleeve (12×100mm) reusable access port system may crack or separate during surgical use. The device is used in minimally invasive procedures. Approximately 2,682 units are affected across multiple lot numbers.

The reusable access port system in this surgical trocar may crack or separate during use. This could compromise the integrity of the device during laparoscopic procedures. The recall affects approximately 25,746 units distributed nationwide and in Canada and Israel.

Ethicon Endo-Surgery's Xcel Bladeless Trocar with OptiView Technology (5mm × 75mm) has a reusable access port system that may crack or separate during surgical use. Approximately 2,838 units have been distributed across the US, Canada, and Israel. No injuries have been reported to date.

The reusable access port system in certain Ethicon XCEL Bladeless Trocars may crack or separate during surgical use. This could affect the instrument's function during a procedure. The affected units have been distributed nationwide and internationally.

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.

Embecta Medical II LLC inadvertently distributed 3,000 pen needles labeled 'For Investigational Use Only' as if they were approved commercial devices. These samples were intended only for research and testing, not for patient use. The needles were distributed across 22 U.S. states.

Embecta Medical II LLC inadvertently distributed 4,300 pen needles labeled 'For Investigational Use Only' as regular commercial products across 22 US states. These devices were meant only for research and testing, not for patient use. No injuries have been reported.

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.

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.

Happiest Baby, Inc. is recalling certain SNOO Sleep Sack sizes (extra-small and extra-large) because these sizes were not reviewed by the FDA for safety and effectiveness before being sold. The smaller and larger sizes do not have the same regulatory clearance as other sizes.

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.

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.

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.

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.

GE Healthcare's Core Services Hub V8 software, used by hospitals to manage medical imaging workflows, can sometimes link historical imaging data to the wrong patient record during system migrations. If this occurs, a doctor might view images belonging to a different patient, potentially leading to wrong diagnoses or delayed care.

GE Healthcare's Workflow Core Services V8 software can sometimes mix up patient imaging data during migration from older systems. When this happens, a patient's medical images may appear under another patient's record, potentially leading to wrong diagnoses or delayed care.

GE Healthcare's Centricity PACS Server V7, used by hospitals and imaging centers to store and display patient X-rays and scans, has a problem: when old images are transferred from an older system, they can occasionally be linked to the wrong patient record. If a doctor pulls up what they think is John Smith's scan, they might see Jane Doe's instead.

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.

GE Healthcare's Enterprise Archive V8 software can occasionally link historical imaging data to the wrong patient when migrating from older systems. If this happens, a patient's medical images may appear under another person's record, potentially leading to missed diagnoses or delayed care.

GE Healthcare's Centricity Enterprise Archive software (versions V2–V4) can incorrectly link historical medical images to the wrong patient during data migration from older systems. If this occurs, a doctor may view or rely on imaging that belongs to another patient, potentially leading to wrong diagnoses or delayed care.

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.

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.

ICU Medical IV tubing sets may contain black specks in the drip chamber, caused by discolored plastic material left behind during manufacturing. Particulate matter in the fluid path has not been ruled out.

ICU Medical IV tubing sets with drip chambers may contain black specks. The specks appear to result from the plastic molding process and may include discolored PVC material in the drip chamber wall. Particulate matter in the fluid path has not been ruled out.

ICU Medical IV tubing sets with drip chambers may contain black specks caused by discolored plastic material from the manufacturing process. The specks could potentially enter the fluid path during use.