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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 901–920 of 1,000 recalls

Class IITerminated

Sharesource Connectivity Platform for Use with the Amia Automated PD System

BAXTER HEALTHCARE CORPORATION

Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the UF (Ultrafiltration) Limit setting as the ending criteria of the cyclers Extra Last Drain Mode. In some locations in the guide, it states that the UF volume achieved must exceed the programmed UF Limit before the cycler will end the Extra Last Drain, allowing the patient to end therapy or proceed to their last fill.

June 30, 2021 · DeviceView details →
Class IITerminated

Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 00884450489611. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.

Merit Medical Systems, Inc.

There is a potential that 7F sheaths are packaged as 10F sheaths.

June 30, 2021 · DeviceView details →
Class IITerminated

RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.

Aesculap Implant Systems LLC

Customized coronal rod benders may deform the implant when used with the spinal system devices.

June 30, 2021 · DeviceView details →
Class IITerminated

Prelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, UDI:(01) 00884450467985. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.

Merit Medical Systems, Inc.

There is a potential that 7F sheaths are packaged as 10F sheaths.

June 30, 2021 · DeviceView details →
Class IITerminated

Kaguya Automated Peritoneal Dialysis System

BAXTER HEALTHCARE CORPORATION

Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the UF (Ultrafiltration) Limit setting as the ending criteria of the cyclers Extra Last Drain Mode. In some locations in the guide, it states that the UF volume achieved must exceed the programmed UF Limit before the cycler will end the Extra Last Drain, allowing the patient to end therapy or proceed to their last fill.

June 30, 2021 · DeviceView details →
Class IITerminated

Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in urology, lithotripsy, gastroenterological surgery and gynecological surgery

Olympus Corporation of the Americas

Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets

June 30, 2021 · DeviceView details →
Class IITerminated

LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.

Aesculap Implant Systems LLC

Customized coronal rod benders may deform the implant when used with the spinal system devices.

June 30, 2021 · DeviceView details →
Class IITerminated

Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Work Chamber 230V. [CooperSurgical part numbers K22400-110, K22200-110, K22400-230, K22200-230, K59500, K59700, K60000, 3.641.831.153, & 3.641.832.153].

CooperSurgical, Inc.

Units are displaying output readings that differ from the measurements taken using a Gas Analyzer. When the display is reading a target setting of 5%, an external meter is reading between 3% and 12% and the Incubator does not alarm. May result in loss of embryo during storage.

June 30, 2021 · DeviceView details →
Class IITerminated

Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler (USV2). Intended Use: Vascular Ultrasound examination table Catalog Number: 66783 and 64219

Oakworks Inc

Weld failure- the bracket attaches the tabletop tilting actuator to the tabletop frame. If the bracket weld fails, the tabletop tilting action is non-functional

June 29, 2021 · DeviceView details →
Class IITerminated

MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001

MY01, INC.

There is an incorrect version of the needle in the introducer part of devices. The affected Lots were manufactured using needles with a needle trocar geometry which is out of specification and may require a slightly higher push force from the user to penetrate the patient skin.

June 28, 2021 · DeviceView details →
Class IITerminated

Infusomat Space Volumetric Pump Administration Set, Product Code 490100

B. Braun Medical, Inc.

There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to follow on screen prompt to close the roller clamp prior to set removal from the pump.

June 25, 2021 · DeviceView details →
Class IITerminated

CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323

Richard Wolf GmbH

Product labeled as Cutting Electrode may contain BIVAP electrode.

June 25, 2021 · DeviceView details →
Class IITerminated

cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001

Roche Diagnostics Operations, Inc.

Under specific circumstances created by the user, the cobas e flow test results could be replaced by an automatic result sent to the lab LIS. This automatic result could be released and interpreted by your Laboratory Information System (LIS) as a false positive or negative result. It should be noted that the "correct" result would still be available on the instrument.

June 24, 2021 · DeviceView details →
Class IITerminated

ETEST IMIPENEM RELEBACTAM. in vitro diagnostic

Biomerieux Inc

Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.

June 24, 2021 · DeviceView details →
Class IITerminated

AMX Navigate Mobile X-Ray System

GE Healthcare, LLC

An unexpected column motion while attempting to park the column on the AMX Navigate mobile X-ray system.

June 24, 2021 · DeviceView details →
Class IITerminated

Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade. Product Number: SCGAA

Covidien Llc

Potential for a manufacturing assembly error-may result in a non-functional audio indicator of device activation or a non-functional device, may cause unintended thermal burn, hemorrhage, or tissue damage and a delay of treatment while an alternate device is located

June 23, 2021 · DeviceView details →
Class IITerminated

MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and displaying medical device data.

BioMerieux SA

Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.

June 22, 2021 · DeviceView details →
Class IITerminated

ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom

Remel Inc

Out of Specification

June 18, 2021 · DeviceView details →
Class IITerminated

Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures

Gentherm Medical, LLC

There is a potential risk of device contamination and patient infection associated with the device because of the potential for organisms (including Nontuberculous mycobacteria NTM) to grow in the water systems of any heater-cooler device, and contaminated water from any heater-cooler device has the potential to aerosolize into the operating room during surgery which could lead to patient infection.

June 17, 2021 · DeviceView details →
Class ITerminated

Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an Umbilical Venous Catheter (UVC) into the umbilical artery or vein of neonate. Product Code: 43201

Cardinal Health 200, LLC

The current Argyle UVC Insertion Tray does not include a specific IFU to operate the Safety Scalpel N11. The Safety Scalpel N11 features a permanent locking feature that will not allow the clinician to unlock the scalpel once the safety shield is closed and pushed forward into a locked position may result in a delay treatment/therapy, which could ultimately result in death.

June 16, 2021 · DeviceView details →
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