FDA Medical Devices
Material regulatory developments from FDA CDRH are tracked daily by Cresthaven Analytics. Over the last 90 days, 20 material briefs relevant to professionals operating in the healthcare & life sciences sector have been published below. Each brief is sourced directly from the primary regulatory feed, summarized for institutional readers, and scored for materiality.
Recent material activity
-
Baxter recalls single lot of Cefazolin in Dextrose Injection over cardboard particulate contamination
Baxter International announced a voluntary nationwide recall on July 24, 2026 of Lot LD175708 (expiry February 14, 2027) of Cefazolin in Dextrose Injection, USP, 2G/100mL, due to cardboard particulate matter found in sol…
Read a full sample brief → -
FDA issues Early Alert on Boston Scientific ENROUTE carotid neuroprotection systems over arterial sheath tip separation risk
FDA's Center for Devices and Radiological Health issued an Early Alert on July 24, 2026 for specific lots of the ENROUTE Transcarotid Neuroprotection System and ENROUTE Transcarotid Neuroprotection System Plus. Boston Sc…
Read a full sample brief → -
Sunny Pharmtech recalls three lots of injectable cyclophosphamide over steel particulate contamination
The FDA published a voluntary nationwide recall by Sunny Pharmtech, Inc. on July 24, 2026, covering three lots of Cyclophosphamide for Injection, USP, in 1g/vial and 2g/vial presentations. Steel particulate matter confir…
Read a full sample brief → -
Unique Pharmaceutical Laboratories recalls four lots of Cetirizine Hydrochloride Tablets USP 5 mg over ranitidine cross-contamination
Unique Pharmaceutical Laboratories, a division of J. B. Chemicals & Pharmaceuticals Ltd., announced on July 18, 2026 a voluntary nationwide recall of four lots of Cetirizine Hydrochloride Tablets USP 5 mg to the consumer…
Read a full sample brief → -
FDA issues Early Alert on Baxter intravascular administration sets over air embolism risk to patients
The FDA issued an Early Alert on July 20, 2026 identifying a defect in Baxter intravascular administration sets that may introduce air bubbles into IV lines during patient use. This action sits at the agency's serious-ha…
Read a full sample brief → -
FDA posts Abiomed 14Fr Low Profile Introducer Kit recall over thrombus formation risk from prolonged use
The FDA published a recall notice for Abiomed's 14Fr Low Profile Introducer Kits, citing thrombus formation risk associated with prolonged device use. Facilities and clinical users of the affected kits must conduct an as…
Read a full sample brief → -
Arrow International issues correction for convenience kits containing recalled Huons lidocaine, bupivacaine, and saline components
On July 16, 2026, the FDA posted an Arrow International correction notice for convenience kits containing previously recalled Huons lidocaine, bupivacaine, and saline. Affected saline, lidocaine, and bupivacaine from the…
Read a full sample brief → -
B. Braun recalls spinal anesthesia convenience kits containing previously recalled Huons bupivacaine hydrochloride components
FDA posted a B. Braun Medical, Inc. convenience kit recall on July 16, 2026, covering spinal anesthesia kits that incorporate Huons bupivacaine hydrochloride in dextrose injection components already subject to a prior re…
Read a full sample brief → -
FDA issues Early Alert for ResMed ventilator issue affecting life-sustaining device population
The FDA has issued an Early Alert identifying a safety issue with ResMed ventilators, a class of life-sustaining medical devices. Clinical users and facilities operating the affected equipment should assess patient safet…
Read a full sample brief → -
Baxter issues field correction for Volera positive pressure breathing devices over patient safety risk
The FDA posted a correction notice for Baxter's Volera positive pressure breathing devices. The correction addresses a safety deficiency that requires action by facilities and clinical users of the affected devices.
Read a full sample brief → -
FDA initiates Class I recall of Medtronic Harmony Delivery Catheter System over serious injury and death risk
The FDA has classified Medtronic's voluntary removal of the Harmony Delivery Catheter System as a Class I recall — the agency's most serious tier — indicating a reasonable probability of serious adverse health consequenc…
Read a full sample brief → -
FDA issues Early Alert for Medline convenience kits over unspecified device safety concern
The FDA issued an Early Alert for convenience kits distributed by Medline Industries, flagging a potential safety issue before formal recall classification is assigned. Early Alerts are the agency's pre-recall notificati…
Read a full sample brief → -
Fresenius Kabi issues field correction for Ivenix large volume infusion pumps rendered inoperable by physical impact
Fresenius Kabi has issued a correction for Ivenix large volume infusion pumps whose touchscreens may become unresponsive after being dropped or jarred. The FDA published the correction notice on July 7, 2026. Affected de…
Read a full sample brief → -
Fresenius Kabi issues software correction for Ivenix Large Volume Infusion Pump over false battery-health readings
FDA published a correction notice on July 7, 2026 for the Fresenius Kabi Ivenix Large Volume Infusion Pump. A software anomaly may generate a false battery-health value, requiring affected pumps to remain connected to AC…
Read a full sample brief → -
Windstone Medical Packaging issues sterility correction for Cardinal Health alcohol prep pads in custom convenience kits
FDA published a device correction notice on July 6, 2026 for Windstone Medical Packaging, Inc., covering Cardinal Health Webcol Large Alcohol Prep Pads assembled into custom convenience kits by Aligned Medical Solutions.…
Read a full sample brief → -
FDA posts Insulet Omnipod Pod recall over tubing tear causing insulin under-delivery
The FDA published a recall notice on July 2, 2026 covering certain Omnipod Pods manufactured by Insulet Corporation. A tubing defect allows insulin to leak outside the Pod rather than reach the patient, creating a risk o…
Read a full sample brief → -
FDA recalls specific Abiomed Impella CP Sets with SmartAssist over out-of-specification purge pressure failure risk
Abiomed is removing specific Impella CP Sets with SmartAssist from the market, as announced by the FDA on July 2, 2026, due to an out-of-specification condition. Affected devices may produce low purge pressure events fro…
Read a full sample brief → -
FDA posts Hamilton Medical breathing circuit correction for obstruction risk affecting ventilator-to-patient connections
The FDA published a device correction notice on July 2, 2026 for Hamilton Medical breathing circuit sets used to connect ventilators to patient tubes or masks. The correction addresses an obstruction risk that may result…
Read a full sample brief → -
FDA posts Hologic BioZorb 3D Bioabsorbable Marker recall over reported patient complication risk
On June 30, 2026, the FDA published a recall notice covering Hologic's BioZorb 3D Bioabsorbable Markers, implantable soft-tissue localization devices. The recall follows reported patient complications associated with the…
Read a full sample brief → -
FDA Medical Devices release pending Cresthaven Analytics full analysis: First Aid Kit Recall: North American Rescue Issues Correction for First Aid Kits Containing TRUE METRIX Devices
FDA Medical Devices published a regulatory release titled 'First Aid Kit Recall: North American Rescue Issues Correction for First Aid Kits Containing TRUE METRIX Devices'. Cresthaven Analytics' full intelligence brief i…
Read a full sample brief →
Get every FDA Medical Devices brief delivered the day it lands
From $149/month
Cresthaven Analytics monitors FDA CDRH continuously, applying institutional materiality scoring to every release. Subscribers receive structured briefs via email, portal, and (Executive tier and above) real-time alerts.
View all tiers →