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Latest medical news · page 100

The latest headlines across every section, pulled from official and open-access sources.

FDA Enforcement · Jul 8, 2026

Device recall: Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and…

Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will result in "exhalation obstructed " alarm, which may result in inadequate ventilation, oxygen desaturation. Advising: Prior to use, test lung action. If alarm occurs, expiratory valve set removal t… — Hamilton Medical AG · Class I · Ongoing · 27,270 pcs

FDA Enforcement · Jul 8, 2026

Device recall: CRE Wireguided 8-10mm 240cm

Potential sterile breach of the pouches in which devices are packaged. — Boston Scientific Corporation · Class II · Ongoing · 81,543 units

FDA Enforcement · Jul 8, 2026

Device recall: Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator

In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing. — Accuray Incorporated · Class II · Ongoing · 292 units

FDA Enforcement · Jul 8, 2026

Device recall: Medline Convenience kits containing recalled Swan-Ganz Catheters CABG A CDS CDS982269K CDS982269L…

Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss. — Medline Industries, LP · Class II · Ongoing · 9,272 kits

FDA Enforcement · Jul 8, 2026

Device recall: Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack), POD-BLE-I1-520 (Single…

External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due t… — Insulet Corporation · Class I · Ongoing · 1,790,784 units

FDA Enforcement · Jul 8, 2026

Device recall: Medline Convenience Kits: 1) LUMBAR PUNCTURE CHOICE, Model Number: DYNDH1215

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. — Medline Industries, LP · Class II · Ongoing · 420 kits

FDA Enforcement · Jul 8, 2026

Device recall: CRE Wireguided 12-15mm 240cm

Potential sterile breach of the pouches in which devices are packaged. — Boston Scientific Corporation · Class II · Ongoing · 81,543 units

FDA Enforcement · Jul 8, 2026

Device recall: CRE Wireguided 15-18mm 240cm

Potential sterile breach of the pouches in which devices are packaged. — Boston Scientific Corporation · Class II · Ongoing · 81,543 units

FDA Enforcement · Jul 8, 2026

Device recall: Medline Convenience Kits: 1) BLOCK TRAY, Model Number: DYNJRA1590

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. — Medline Industries, LP · Class II · Ongoing · 270 kits

FDA Enforcement · Jul 8, 2026

Device recall: A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-

Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit. — Windstone Medical Packaging, Inc. · Class I · Ongoing · 200 units

FDA Enforcement · Jul 8, 2026

Device recall: Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474;…

There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after ad… — Baxter Healthcare Corporation · Class I · Ongoing · 13881 units

FDA Enforcement · Jul 8, 2026

Device recall: CRE Wireguided 6-8mm 240cm

Potential sterile breach of the pouches in which devices are packaged. — Boston Scientific Corporation · Class II · Ongoing · 81,543 units

FDA Enforcement · Jul 8, 2026

Device recall: CRE Wireguided 18-20mm 240cm

Potential sterile breach of the pouches in which devices are packaged. — Boston Scientific Corporation · Class II · Ongoing · 81,543 units

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