Tag archive

device_vigilance

publicFDA · USA · Updated Jun 5, 2026

GE HealthCare Carestation Devices - Correction for Ineffective Ventilation in VCV Mode (FDA Class I Recall)

Do not use VCV mode until corrected. Use PCV or PCV-VG mode. Perform Ventilation Screening Test. Return acknowledgement form to GE HealthCare.

Signal ManagementLabelingRegulatory Intelligence Lead

SOP Impact2 SOPs

Relevant for: Regulatory Intelligence Lead, Signal Management Lead

verifiedRegulatory action: Medical Device Recall / Correction

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publicHealth Canada · Canada · Updated Jun 4, 2026

Giraffe™ OmniBed™ Carestation™ - Fastener Disengagement Risk

Healthcare facilities should implement manufacturer's corrective actions to ensure safe operation.

Signal ManagementLabelingRegulatory Intelligence Lead

SOP Impact2 SOPs

Relevant for: Regulatory Intelligence Lead, Signal Management Lead

verifiedRegulatory action: Medical Device Recall

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publicMedicines and Healthcare products Regulatory Agency (MHRA) · United Kingdom · Updated Jun 2, 2026

MHRA Class 2 Recall: ChloraPrep 2% applicators (potential sterility breach)

Identify and quarantine all impacted batches of ChloraPrep 2% 1mL and Frepp 2% 1.5mL applicators; return to Becton Dickinson UK Ltd.

Signal ManagementLabelingRegulatory Intelligence Lead

SOP Impact2 SOPs

Relevant for: Regulatory Intelligence Lead, Signal Management Lead

verifiedRegulatory action: Class 2 Medicines Recall

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publicUpdated Jun 4, 2026

Hintermann Series H3 Total Ankle Replacement: Higher-Than-Expected Risk of Device Failure - FDA Safety Communication

Review impact brief for required actions.

ConfidenceMedium

verifiedRegulatory action: Regulators

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Tag: device_vigilance | PV Bulletin