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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 2021–2040 of 39,430 recalls

Class IIIOngoing

Cardiosave Rescue

Datascope Corp.

The IFU addendum updates the Vibration and Shock Table to reference the correct standards.

October 23, 2025 · DeviceView details →
Class IIIOngoing

Cardiosave Hybrid

Datascope Corp.

The IFU addendum updates the Vibration and Shock Table to reference the correct standards.

October 23, 2025 · DeviceView details →
Class II
Ongoing

BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;

Becton Dickinson & Co.

The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instrument enters an error state and the cuvettes cannot be used.

October 23, 2025 · DeviceView details →
Class IIOngoing

Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S

Olympus Corporation of the Americas

Firm is initiating a removal due to continued reports of adverse events.

October 22, 2025 · DeviceView details →
Class IIOngoing

Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip

Olympus Corporation of the Americas

Firm is initiating a removal due to continued reports of adverse events.

October 22, 2025 · DeviceView details →
Class IIOngoing

Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S

Olympus Corporation of the Americas

Firm is initiating a removal due to continued reports of adverse events.

October 22, 2025 · DeviceView details →
Class IIOngoing

Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip

Olympus Corporation of the Americas

Firm is initiating a removal due to continued reports of adverse events.

October 22, 2025 · DeviceView details →
Class IIOngoing

Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip

Olympus Corporation of the Americas

Firm is initiating a removal due to continued reports of adverse events.

October 22, 2025 · DeviceView details →
Class IIOngoing

Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip

Olympus Corporation of the Americas

Firm is initiating a removal due to continued reports of adverse events.

October 22, 2025 · DeviceView details →
Class IIOngoing

Olympus Thunderbeat 5 mm, 10 cm, Inline Grip

Olympus Corporation of the Americas

Firm is initiating a removal due to continued reports of adverse events.

October 22, 2025 · DeviceView details →
Class IIOngoing

BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)

BioFire Diagnostics, LLC

Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.

October 22, 2025 · DeviceView details →
Class IIOngoing

Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S

Olympus Corporation of the Americas

Firm is initiating a removal due to continued reports of adverse events.

October 22, 2025 · DeviceView details →
Class IIOngoing

Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip

Olympus Corporation of the Americas

Firm is initiating a removal due to continued reports of adverse events.

October 22, 2025 · DeviceView details →
Class IIOngoing

Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip

Olympus Corporation of the Americas

Firm is initiating a removal due to continued reports of adverse events.

October 22, 2025 · DeviceView details →
Class IIOngoing

Olympus Thunderbeat, 5 mm, 45 cm Inline Grip

Olympus Corporation of the Americas

Firm is initiating a removal due to continued reports of adverse events.

October 22, 2025 · DeviceView details →
Class IIOngoing

Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip

Olympus Corporation of the Americas

Firm is initiating a removal due to continued reports of adverse events.

October 22, 2025 · DeviceView details →
Class IIIOngoing

VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade.

Accriva Diagnostics, Inc.

Due to an device without a premarket clearance being incorrectly package and distributed.

October 21, 2025 · DeviceView details →
Class IIOngoing

CareLink Clinic, REF: MMT-7350

Medtronic MiniMed, Inc.

Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed on the 24-hour sensor glucose overview graph may lead to hypoglycemia or hyperglycemia.

October 21, 2025 · DeviceView details →
Class IIOngoing

Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Sev E_Vap. (Safety Filling adapter), Part Number: 115-066756-00. 2. Exchange Sev E_Vap. (Safety Filling adapter), Part Number: E115-066756-00. Product Description: The Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A9 Anesthesia System utilizes V90 electronic vaporizers for anesthetic agent delivery.

Mindray DS USA, Inc. dba Mindray North America

Potential for anesthesia leakage.

October 20, 2025 · DeviceView details →
Class IIOngoing

Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03

Medtronic Perfusion Systems

Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges.

October 20, 2025 · DeviceView details →
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