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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 541–560 of 1,000 recalls

Class IOngoing

Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.

Bausch & Lomb Surgical, Inc.

In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.

March 27, 2025 · DeviceView details →
Class IOngoing

Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA; enVista Monofocal Toric IOL, All models starting with ETE; enVista Aspire Toric IOL, All models starting with ETA;

Bausch & Lomb Surgical, Inc.

In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.

March 27, 2025 · Device
View details →
Class IOngoing

GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002. Anesthesia system.

GE Medical Systems China Co., Ltd.

Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.

March 21, 2025 · DeviceView details →
Class IOngoing

GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system.

GE Medical Systems China Co., Ltd.

Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.

March 21, 2025 · DeviceView details →
Class IOngoing

GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002. Anesthesia system.

GE Medical Systems China Co., Ltd.

Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.

March 21, 2025 · DeviceView details →
Class IOngoing

GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012. Anesthesia system.

GE Medical Systems China Co., Ltd.

Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.

March 21, 2025 · DeviceView details →
Class IOngoing

GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200. Anesthesia system.

GE Medical Systems China Co., Ltd.

Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.

March 21, 2025 · DeviceView details →
Class IOngoing

GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002. Anesthesia system.

GE Medical Systems China Co., Ltd.

Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.

March 21, 2025 · DeviceView details →
Class IOngoing

GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002. Anesthesia system.

GE Medical Systems China Co., Ltd.

Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.

March 21, 2025 · DeviceView details →
Class IOngoing

GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012. Anesthesia system.

GE Medical Systems China Co., Ltd.

Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.

March 21, 2025 · DeviceView details →
Class IOngoing

GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002. Anesthesia system.

GE Medical Systems China Co., Ltd.

Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.

March 21, 2025 · DeviceView details →
Class IOngoing

GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system.

GE Medical Systems China Co., Ltd.

Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.

March 21, 2025 · DeviceView details →
Class IOngoing

GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. Anesthesia system.

GE Medical Systems China Co., Ltd.

Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.

March 21, 2025 · DeviceView details →
Class IOngoing

GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000. Anesthesia system.

GE Medical Systems China Co., Ltd.

Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.

March 21, 2025 · DeviceView details →
Class IOngoing

GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems

GE Medical Systems China Co., Ltd.

Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.

March 21, 2025 · DeviceView details →
Class IOngoing

GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000. Anesthesia system.

GE Medical Systems China Co., Ltd.

Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.

March 21, 2025 · DeviceView details →
Class IOngoing

GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200. Anesthesia system.

GE Medical Systems China Co., Ltd.

Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.

March 21, 2025 · DeviceView details →
Class IOngoing

Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI Component: N/A

Avanos Medical, Inc.

Lack of sterility assurance for closed suction catheter systems

March 19, 2025 · DeviceView details →
Class IOngoing

Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Y-Adapter Component: No

Avanos Medical, Inc.

Lack of sterility assurance for closed suction catheter systems

March 19, 2025 · DeviceView details →
Class IOngoing

Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 20083 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Elbow Component: N/A

Avanos Medical, Inc.

Lack of sterility assurance for closed suction catheter systems

March 19, 2025 · DeviceView details →
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