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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 4121–4140 of 39,430 recalls

Class IIOngoing

Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 and 14.0.0.3338 Software Version: RayStation 12A, 12A Service Pack 1 and 2 and 2023B

RAYSEARCH LABORATORIES AB

Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.

January 16, 2025 · DeviceView details →
Class IIOngoing

Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 5.0.2.35 and 5.0.3.17 Software Version: RayStation 5 Service Pack 2 and 3

RAYSEARCH LABORATORIES AB

Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.

January 16, 2025 · DeviceView details →
Class IIOngoing

Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.0.0.24 Software Version: RayStation 6

RAYSEARCH LABORATORIES AB

Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.

January 16, 2025 · DeviceView details →
Class IIOngoing

ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.

TERRAGENE S.A.

Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.

January 15, 2025 · DeviceView details →
Class IIOngoing

IntelliVue Patient Monitor MX400. Model Number: 866060

Philips North America Llc

Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.

January 15, 2025 · DeviceView details →
Class IIOngoing

IntelliVue Patient Monitor MX450. Model Number: 866062

Philips North America Llc

Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.

January 15, 2025 · DeviceView details →
Class IOngoing

Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Sheath Kit K-201 2.0MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush; Model Number: K-201 2. Single Use Guide Sheath Kit K-202 2.0MM Channel Set: Guide Sheath, Biopsy Forceps; Model Number: K-202 3. Single Use Guide Sheath Kit K-203 2.6MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush; Model Number: K-203 4. Single Use Guide Sheath Kit K-204 2.6MM Channel Set: Guide Sheath, Biopsy Forceps; Model Number: K-204. Used to collect cells or tissue specimens in the respiratory organs.

Olympus Corporation of the Americas

Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.

January 15, 2025 · DeviceView details →
Class IIOngoing

IntelliVue Patient Monitor MX550. Model Number: 866066

Philips North America Llc

Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.

January 15, 2025 · DeviceView details →
Class IIOngoing

DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movement

DeRoyal Industries Inc

The tubing may not ensure that the yankauer stays intact, and secure to the tubing / yankauer connection for a tight seal. This could result in inadequate suction and cause delay in patient care.

January 15, 2025 · DeviceView details →
Class IIOngoing

MOSAIQ Oncology Information System

Elekta, Inc.

Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.

January 15, 2025 · DeviceView details →
Class IIOngoing

IntelliVue Patient Monitor MX500. Model Number: 866064

Philips North America Llc

Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.

January 15, 2025 · DeviceView details →
Class IOngoing

Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e. For use during anesthesia.

Getinge Usa Sales Inc

Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalation and/or skin exposure. Potential harms include irritation of respiratory tract, which in worst case may lead to lung edema and/or severe hypocalcemia, blistering, superficial ulceration, and/or hypomagnesemia.

January 15, 2025 · DeviceView details →
Class IIOngoing

IntelliBridge EC10 Module. Model Number: 865115

Philips North America Llc

Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.

January 15, 2025 · DeviceView details →
Class IIOngoing

Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/A

Hologic, Inc

Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.

January 15, 2025 · DeviceView details →
Class IIOngoing

Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of data from networked patient monitors including the annunciation of visual and audible physiologic parameter alarms at a central monitoring workstation.

Draeger Medical Systems, Inc.

Edifier speakers (shipped in or after April 2023) may not annunciate when configured in analog mode which can lead to delayed treatment to the patient.

January 14, 2025 · DeviceView details →
Class IIOngoing

Azurion 3 M12 System Code: (1) 722063 (2) 722221

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel

January 13, 2025 · DeviceView details →
Class IOngoing

Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Allura CV20; Catalog numbers: 722031

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
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