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
A selection of recent published briefs; this is not a complete archive.
FDA Class I recall removes all Abiomed Automated Impella Controllers over purge flag failures linked to 37 injuries and three deaths
The FDA has classified Abiomed's removal of all Automated Impella Controllers as a Class I recall — its most serious designation — following purge flag component failures within the purge pressure sensor assembly. As of …
Read the full FDA Medical Devices brief →FDA classifies BD convenience kit correction as Class I recall over recalled sodium chloride ampules
The FDA on September 24, 2026 elevated its August 18 Early Alert for Becton Dickinson convenience kits and procedure trays to a Class I recall classification. The kits contain sodium chloride ampules subject to a prior H…
Read the full FDA Medical Devices brief →FDA issues Early Alert for VOCSN ventilator connector fault that can interrupt life-sustaining therapy
FDA's Center for Devices and Radiological Health issued an Early Alert on September 23, 2026 covering all VOCSN ventilator models with serial numbers 112786 and higher. React Health identified a connector fault in the in…
Read the full FDA Medical Devices brief →Par Health recalls two lots of dexmedetomidine injection over particulate contamination at hospital level
Par Health announced a voluntary nationwide recall on September 18, 2026 covering two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL. The recall extends to the hospital level. Particulate ma…
Read the full FDA Medical Devices brief →Otsuka ICU Medical recalls one lot of saline injection after potassium chloride mix-up creates patient safety risk
Otsuka ICU Medical LLC announced a voluntary nationwide recall on September 21, 2026 covering one lot of 0.9% Sodium Chloride Injection, USP 100mL single packs. The affected lot may carry overwrap labeling from 10 mEq Po…
Read the full FDA Medical Devices brief →FDA Medical Devices release pending Cresthaven Analytics full analysis: Convenience Kit Correction: AVID Medical Issues Correction for Kits Containing Huons Sodium Chloride Ampules
FDA Medical Devices published a regulatory release titled 'Convenience Kit Correction: AVID Medical Issues Correction for Kits Containing Huons Sodium Chloride Ampules'. Cresthaven Analytics' full intelligence brief is p…
Read the full FDA Medical Devices brief →FDA Class I recall removes Spectra Medical sodium chloride flush ampules over sterility failures at Huons manufacturing facility
The FDA has classified a Spectra Medical Devices recall of Sodium Chloride Injection 0.9% USP 10mL ampules as Class I, its most serious tier. The recall stems from quality deficiencies identified during an FDA inspection…
Read the full FDA Medical Devices brief →FDA classifies NOxBOXi Nitric Oxide Delivery System oxygen leak as Class II Recall
The FDA classified a correction for the NOxBOXi Nitric Oxide Delivery System as a Class II Recall on September 18, 2026. Oxygen tubing failures within the NOxMixer module can cause nitric oxide overdose or therapy interr…
Read the full FDA Medical Devices brief →FDA Medical Devices release pending Cresthaven Analytics full analysis: Esophageal pH Monitoring Capsule Recall: Medtronic and Given Imaging Remove Esophageal pH Monitoring Capsule Delivery Device
FDA Medical Devices published a regulatory release titled 'Esophageal pH Monitoring Capsule Recall: Medtronic and Given Imaging Remove Esophageal pH Monitoring Capsule Delivery Device'. Cresthaven Analytics' full intelli…
Read the full FDA Medical Devices brief →FDA posts Centric Compounding nationwide recall of six injectable lots over elevated endotoxin contamination
Centric Compounding has voluntarily recalled six lots of injectable Glutathione 200mg/mL, Myers' Cocktail, and Tri-Immune Boost distributed nationwide, with the recall initiated September 9, 2026. The root cause is eleva…
Read the full FDA Medical Devices brief →FDA Medical Devices release pending Cresthaven Analytics full analysis: Epidural Kit Correction: Medical Action Industries Issues Correction for Epidural Kits Containing Spectra Medical Devices Lidocaine Ampules
FDA Medical Devices published a regulatory release titled 'Epidural Kit Correction: Medical Action Industries Issues Correction for Epidural Kits Containing Spectra Medical Devices Lidocaine Ampules'. Cresthaven Analytic…
Read the full FDA Medical Devices brief →FDA records retrospective recall of 20,160 BMC Luna G3 APAP sleep therapy devices over firmware defect
BMC Medical Co., Ltd. reported to the FDA on July 15, 2026 a recall of 20,160 Luna G3 APAP (Model LG3600) devices distributed in the United States, citing a firmware defect in version G3-2.00.76. The company did not noti…
Read the full FDA Medical Devices brief →FDA Class I recall targets Boston Scientific Infinion CX Lead over fracture and inadequate stimulation risk
The FDA has classified a Boston Scientific voluntary recall of the Infinion CX Lead as Class I, its most serious designation, effective June 17, 2026. The recall covers unused units of two lead kit models across all U.S.…
Read the full FDA Medical Devices brief →FDA Early Alert flags cracked VentStar Resus Neo infant breathing hoses with hypoxia and death risk
FDA's Center for Devices and Radiological Health issued an Early Alert on September 3, 2026 for the Draeger VentStar Resus Neo breathing circuit, model MP00310, used in neonatal resuscitation. Draeger notified affected c…
Read the full FDA Medical Devices brief →FDA classifies GE HealthCare Portrait Core Services software discharge risk as Class II recall
The FDA on September 3, 2026 reclassified a previously issued Early Alert for GE HealthCare Portrait Core Services software as a Class II recall. The defect can silently discharge patients from active monitoring and rese…
Read the full FDA Medical Devices brief →FDA classifies Medline convenience kit sterility breach as Class II recall affecting surgical-use ChloraPrep applicators
The FDA classified this correction as a Class II recall on September 2, 2026, covering Medline convenience kits that contain specific lots of BD ChloraPrep Clear 1 mL and FREPP Clear 1.5 mL applicators with compromised s…
Read the full FDA Medical Devices brief →FDA Early Alert flags AVID Medical convenience kits containing recalled Huons sodium chloride ampules
FDA's Center for Devices and Radiological Health issued an Early Alert on September 2, 2026 identifying 18 lot numbers across four AVID Medical convenience kit models containing sodium chloride ampules subject to a prior…
Read the full FDA Medical Devices brief →FDA posts Medline recall of neonatal and infant heated wire breathing circuits over electrical connector failures
The FDA published a recall notice on September 1, 2026 for eighteen Hudson RCI neonatal and infant heated wire breathing circuit configurations distributed by Medline. Electrical connector failures at the Neptune humidif…
Read the full FDA Medical Devices brief →FDA confirms undeclared fluoxetine and DNP in recalled dietary supplement Lipofit Extreme Fat Burner 2.0
On August 27, 2026, Ana Salazar Modela Tu Cuerpo Inc. issued a nationwide voluntary recall of Lipofit Extreme Fat Burner 2.0, Lot 25M12F, after FDA laboratory testing confirmed the presence of undeclared fluoxetine and 2…
Read the full FDA Medical Devices brief →FDA CDRH Early Alert flags Avid Medical IV Start Kit for Aspergillus fungal contamination risk
FDA's Center for Devices and Radiological Health issued an Early Alert on August 28, 2026, for Avid Medical IV Start Kit lot 1658437, which contains recalled BD ChloraPrep applicators potentially contaminated with Asperg…
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