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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 261–280 of 1,000 recalls

Class IIOngoing

ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600

IMRIS Imaging Inc

The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the patient if unintended rotational movement occurs during a procedure.

August 6, 2026 · DeviceView details →
Class IIOngoing

LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Versions (Current 7.8)

Boston Scientific Corporation

There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.

August 6, 2026 · Device
View details →
Class IIOngoing

Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA

Volcano Corp

Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.

August 6, 2026 · DeviceView details →
Class IIOngoing

Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610, S2000, S1610 multimodal imaging platform optimized for the posterior segment of the eye

Heidelberg Engineering GmbH

Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip over as a result. Falling stand may cause impact or crushing injuries, particularly to the feet, legs, hands or arms of the operator or nearby persons.

August 6, 2026 · DeviceView details →
Class IOngoing

Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack, Product Number FGS-0636. Used to attach a pH monitoring capsule to the esophagus.

Given Imaging Ltd.

Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient.

August 6, 2026 · DeviceView details →
Class IIOngoing

LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All Versions (Current 7.7)

Boston Scientific Corporation

There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.

August 6, 2026 · DeviceView details →
Class IIOngoing

LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model Number 7246, All Versions (Current 7.7)

Boston Scientific Corporation

There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.

August 6, 2026 · DeviceView details →
Class IIOngoing

MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201

Nipro Renal Soultions USA, Corporation

Hemodialysis concentrates contain high endotoxin levels

August 5, 2026 · DeviceView details →
Class IIOngoing

Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)

Nipro Renal Soultions USA, Corporation

Hemodialysis concentrates contain high endotoxin levels

August 5, 2026 · DeviceView details →
Class IIOngoing

MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))

Nipro Renal Soultions USA, Corporation

Hemodialysis concentrates contain high endotoxin levels

August 5, 2026 · DeviceView details →
Class IIOngoing

Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25

Nipro Renal Soultions USA, Corporation

Hemodialysis concentrates contain high endotoxin levels

August 5, 2026 · DeviceView details →
Class IIOngoing

Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.

Canon Medical System, USA, INC.

Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose.

August 4, 2026 · DeviceView details →
Class IIOngoing

Brand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number: S070031.520; Software Version: 3.1.18;

PTW FREIBURG

When a bolus is included in a treatment plan and sent for secondary dose calculation, the software accounts for it but does not display this clearly, which may lead users to incorrectly omit the bolus during treatment and deliver the prescribed dose to the wrong tissue depth.

August 4, 2026 · DeviceView details →
Class IIOngoing

Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025

B Braun Medical Inc

Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label.

August 4, 2026 · DeviceView details →
Class IIOngoing

Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: B96692 / 14987666542965 B96693 / 14987666542972 B12183 / 14987666540671 The AU480 Chemistry Analyzer measure analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material, and other accessories. This system is for in vitro diagnostic use only.

Beckman Coulter Mishima K.K.

Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message System Stopped By Fatal Error: DBConnectionError AlarmDB when launching the instrument software, using PC pre-installed with Microsoft SQL Server 2022 Express. When this occurs, AlarmDB becomes unreadable and the instrument software cannot be started. This causes a delay in obtaining patient results.

August 3, 2026 · DeviceView details →
Class IIOngoing

Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A Product Description: VOLARA, HOMECARE, NORTH AMERICA Component: No

Baxter Healthcare Corporation

Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to firm and testing confirmed devices meet specifications.

August 3, 2026 · DeviceView details →
Class IIOngoing

HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN) HEALON EndoCoat PRO, REF: 10301012 (EU); HEALON DUET PRO II, REF: 10301016 (EU)

Johnson & Johnson Surgical Vision, Inc.

Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resistance is encountered during insertion, withdraw cannula and reassess the insertion conditions (i.e. insertion angle, incision size, etc.) before proceeding because forcing the cannula may cause corneal abrasion, iris trauma or descemet's membrane detachment.

July 31, 2026 · DeviceView details →
Class IIOngoing

Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions

GE Healthcare

Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.

July 31, 2026 · DeviceView details →
Class IIOngoing

Philips PIC iX Essentials REF:867093

Philips North America

Due to software malfunction, patient information system may freeze and become unresponsive.

July 31, 2026 · DeviceView details →
Class IIOngoing

New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large. Model Number: NYES100-2. Packaged in inner packs of 10 and 100 gowns per shipping case.

New York Embroidery Studio, Inc.

Gowns do not consistently meet the minimum liquid-barrier performance required.

July 31, 2026 · DeviceView details →
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