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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 3061–3080 of 39,430 recalls

Class IIOngoing

PARTIAL NEPHRECTOMY - ROBOTIC. Medical convenience kit.

AVID Medical, Inc.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

June 11, 2025 · DeviceView details →
Class IIOngoing

LAPAROSCOPIC GYN. Medical convenience kit.

AVID Medical, Inc.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

June 11, 2025 · DeviceView details →
Class II
Ongoing

Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)

RECORDATI RARE DISEASES INC.

Out of specification stability test result for the Caphosol B solution from process validation lots

June 11, 2025 · DeviceView details →
Class IIOngoing

LAPAROSCOPIC TRAY. Medical convenience kit.

AVID Medical, Inc.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

June 11, 2025 · DeviceView details →
Class IIOngoing

ROBOTIC URO/GYN PACK. Medical convenience kit.

AVID Medical, Inc.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

June 11, 2025 · DeviceView details →
Class IIOngoing

GYN LAPAROSCOPY PACK. Medical convenience kit.

AVID Medical, Inc.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

June 11, 2025 · DeviceView details →
Class IIOngoing

ROBOTIC PROSTATECTOMY PACK. Medical convenience kit.

AVID Medical, Inc.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

June 11, 2025 · DeviceView details →
Class IIOngoing

GENERAL LAPAROSCOPY TRAY. Medical convenience kit.

AVID Medical, Inc.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

June 11, 2025 · DeviceView details →
Class IIOngoing

GEN LAPAROSCOPY PACK. Medical convenience kit.

AVID Medical, Inc.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

June 11, 2025 · DeviceView details →
Class IIOngoing

LAPAROSCOPY PACK. Medical convenience kit.

AVID Medical, Inc.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

June 11, 2025 · DeviceView details →
Class IIOngoing

Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.

CooperSurgical, Inc.

The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.

June 11, 2025 · DeviceView details →
Class IIOngoing

MAJOR THORACOSCOPY BASIN. Medical convenience kit.

AVID Medical, Inc.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

June 11, 2025 · DeviceView details →
Class IIOngoing

PARTIAL NEPHRECTOMY PACK. Medical convenience kit.

AVID Medical, Inc.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

June 11, 2025 · DeviceView details →
Class IIOngoing

ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

FUJIFILM Healthcare Americas Corporation

Devices had an unapproved slabbing software function enabled for use.

June 11, 2025 · DeviceView details →
Class IIOngoing

HVI CARDIAC ROBOT PACK. Medical convenience kit.

AVID Medical, Inc.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

June 11, 2025 · DeviceView details →
Class IIOngoing

Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit

CooperSurgical, Inc.

The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.

June 11, 2025 · DeviceView details →
Class IIOngoing

GENERAL ROBOTIC PACK. Medical convenience kit.

AVID Medical, Inc.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

June 11, 2025 · DeviceView details →
Class IIOngoing

HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterography procedures.

CooperSurgical, Inc.

The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.

June 11, 2025 · DeviceView details →
Class IIOngoing

CARDIAC ROBOT PACK. Medical convenience kit.

AVID Medical, Inc.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

June 11, 2025 · DeviceView details →
Class IIOngoing

DAVINCI UROLOGY. Medical convenience kit.

AVID Medical, Inc.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

June 11, 2025 · DeviceView details →
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