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FDA medical device recalls

Medical device recalls from FDA, newest first. 890 recalls Dates are when each recall was announced (how we date recalls).
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4 recalls that day

Olympus ShockPulse-SE Lithotripsy System Reusable Probes, Single Use Probes and Generator

The device can remain in a blinking phase waiting to recognize the transducer.

Moderate risk, FDA, Device defect

3 recalls that day

Medtronic Perfusion Systems Octopus Nuvo Tissue Stabilizer

The Octopus Nuvo Tissue Stabilizer has an assembly issue where tubing was incorrectly positioned.

Moderate risk, FDA, Manufacturing problem

Remel Campy CVA Medium

Customer complaints report low to no recovery of Campylobacter Jejuni on the identified lot.

Moderate risk, FDA, Device defect

Agiliti Health - Ellis Adapt Pump

The Adapt Pump does not re-engage the Microclimate Management function after using the Autofirm function for 10 minutes.

Moderate risk, FDA, Device defect

3 recalls that day

Medline Kits with Tego Connectors

Medline Kits with Tego Connectors may have silicone seal issues that can cause fluid leakage or air infusion.

Moderate risk, FDA, Contamination

Encore Medical Reverse Shoulder Prosthesis and EMPOWR 3D Knee Inserts

Knee and humeral socket implants contain incorrect labeling.

Moderate risk, FDA, Labeling error

PIE PAK and Trolley System

Edermy is recalling its Pie Pak and PIE Trolley System because of the lack of 510K clearance.

Moderate risk, FDA, Unapproved product

5 recalls that day

Medline Sterile Saline Wound Wash and Convenience Kits

Medline Sterile Saline Wound Wash, Medline Convenience Kits, and Meijer Sterile saline wound wash may not meet sterility requirements.

Moderate risk, FDA, Sterility problem

Hitachi Proton Beam Therapy

Hitachi Proton Beam Therapy may result in positional discrepancy.

Moderate risk, FDA, Software defect

MRIMed MRI LED Mobile Exam Light Battery

Due to battery component overheating while charging resulting in melting of internal components and causing smoke.

Moderate risk, FDA, Device defect

Olympus Resection and Inner Sheaths

Olympus Resection and Inner Sheaths can break at the ceramic tip.

Moderate risk, FDA, Device defect

Olympus Cystoscope Outer Sheath

The Olympus Cystoscope Outer Sheath is being removed due to incompatibility with a GreenLight Laser that could damage the device tip.

Moderate risk, FDA, Device defect

2 recalls that day

Olympus High Flow Insufflation Unit

The Olympus High Flow Insufflation Unit has a software algorithm issue that may lead to overpressure events.

High risk, FDA, Software defect

Intuitive Surgical Da Vinci 5 Console

The Da Vinci 5 surgical system can have an error event that causes loss of user interface content on a monitor.

Moderate risk, FDA, Software defect

5 recalls that day

Medline Convenience Kits and Surgical Drapes

Medline Convenience Kits and Surgical Drapes may not be sterile due to calibration issues in sterilization equipment.

Moderate risk, FDA, Sterility problem

Auris Health MONARCH Bronchoscopy Platform

The Monarch Platform, a bronchoscopy device, has a software issue that may cause unanticipated robotic arm positioning toward patient-left.

Moderate risk, FDA, Software defect

Stryker MOLLI 2 System, Introducers, Wand, OncoPen and Tablet

The Molli 2 System has labeling that needs updating because magnetized surgical tools can dislodge markers.

Moderate risk, FDA, Labeling error

Olympus Thunderbeat Surgical Devices

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

Moderate risk, FDA, Device defect

Centinel Spine Prodisc C SK Total Cervical Disc Replacement

Prodisc C SK total cervical disc replacement was mislabeled as the 6mm product but included the 5 mm product.

Moderate risk, FDA, Labeling error

7 recalls that day

MediHoney Gel and Calcium Alginate Dressings

Potential packaging failures, which could lead to a breach in the sterile barrier.

Moderate risk, FDA, Sterility problem

Spectrum IQ Infusion Pump

The Spectrum IQ Infusion Pump was released without full testing, including occlusion alarm testing.

Moderate risk, FDA, Device defect

Wilson-Cook Teslatome Bipolar Sphincterotomes

Teslatome Bipolar Sphincterotomes may have a void separating wire guide and cutting wire lumens, causing inappropriate current path.

Moderate risk, FDA, Device defect

Immunotech Estrone RIA

Estrone RIA may rarely give falsely high patient results, which might cause temporary injury.

Moderate risk, FDA, Device defect

Bard Peripheral Vascular Broviac Single-Lumen CV Catheter Cutdown Tray

The Broviac catheter tray has a damaged outer tray that can compromise the sterile barrier.

Moderate risk, FDA, Sterility problem

Medline IV Administration and Extension Sets

IV administration and extension sets may leak, crack, or break during use, causing treatment delays, blood loss, infection, air embolism, or underdosage.

Moderate risk, FDA, Device defect

Medica Capillary Tubes and EasyBloodGas/EasyStat Capillary Tube Kit

Medica Capillary Tubes can falsely elevate potassium results in patient samples.

Moderate risk, FDA, Device defect

3 recalls that day

Intuitive Surgical da Vinci 5 Surgeon Console Viewer Display

The da Vinci 5 Surgeon Console Viewer Display has outdated firmware that may cause loss of 3D or complete visualization, potentially leading to injury.

Moderate risk, FDA, Software defect

Steris Barco MNA with HexaVue IP Integration System

The Barco MNA with the HexaVue IP Integration System was made with an incorrect configuration file.

Moderate risk, FDA, Device defect

Surepulse VS Newborn Heart Rate Monitor Caps

Surepulse VS Cap has labeling with an incorrect sizing guide.

Low risk, FDA, Labeling error

3 recalls that day

Philips Azurion Systems

Azurion systems may move unexpectedly when the Reset Geometry button is pressed, even with a table lock active.

Moderate risk, FDA, Device defect

Laerdal Compact Suction Unit 4 RTCA Version

The Laerdal Compact Suction Unit 4 Rtca version may emit electromagnetic noise beyond acceptable limits.

Moderate risk, FDA, Device defect

ATEC Lateral Navigation Disc Prep Instruments

ATEC Lateral Navigation Disc Prep Instruments have a design issue with incorrect navigated array connection geometry.

Moderate risk, FDA, Device defect

1 recall that day

Elekta Leksell GammaPlan Radionuclide RT Treatment Planning System

Leksell GammaPlan treatment planning software has an error that may irradiate the incorrect patient location.

Moderate risk, FDA, Device defect

3 recalls that day

Halyard Transport Bag Kit

The Halyard Transport Bag Kit has a Tyvek bag seal issue that may compromise sterility.

Moderate risk, FDA, Sterility problem

Straumann WB Impression Post Closed Tray

The impression post closed tray contains magenta caps instead of brown caps.

Low risk, FDA, Device defect

Medline Medical Convenience Kits

Medline medical convenience kits may have an open seal on the packaging of the applicators.

Moderate risk, FDA, Device defect

5 recalls that day

Trividia Health TRUE METRIX Blood Glucose Meter Owner's Booklets and Instructions

The labeling for True Metrix blood glucose meters does not adequately explain the E-5 error code, which could delay treatment.

High risk, FDA, Labeling error

Philips Brilliance iCT and Spectral CT Scanners

Some fasteners in the CT system may not be torqued to specification.

Moderate risk, FDA, Device defect

Hologic Brevera Breast Biopsy System Disposable Needle

The Brevera Breast Biopsy System Disposable 9 Gauge Needle contains particulates that can be deposited into breast tissue during use.

Moderate risk, FDA, Foreign object

Medline ReNewal Reprocessed Diagnostic Catheters

Reprocessed catheters may contain small particles of residual material, posing risks of embolism or thrombosis.

High risk, FDA, Foreign object

Medline Suction Catheter Kits and Intubation Tray

Medline Suction Catheter Kits and Intubation Tray may contain a smaller 8 Fr catheter, which can cause airway obstruction.

Moderate risk, FDA, Device defect

7 recalls that day

Olympus Sphincterotomes

Single Use 3-Lumen Sphincterotome V devices that did not undergo thermoforming could deform and lose performance.

Moderate risk, FDA, Device defect

Maquet Cardiopulmonary Bubble Sensor

The Bubble Sensor for 3/8" x 3/32" tubing has a durability issue with its connecting cable that can cause sensor damage or loose contact.

Moderate risk, FDA, Device defect

FUJIFILM FDR Visionary Suite

The FDR Visionary Suite X-ray high-voltage generator can overheat and damage parts, possibly causing smoke.

Moderate risk, FDA, Device defect

Molift Mover 205, Mover 300 and Sling Bars

The Molift Mover 205, Mover 300, and sling bars can have a broken bolt that limits joint mobility, preventing proper functionality.

Moderate risk, FDA, Device defect

Fujirebio Lumipulse G Plasma Assays, Calibrators and Controls

The tests may produce inaccurate results with a higher frequency of classification in the indeterminate and positive zone and/or low specificity.

Moderate risk, FDA, Device defect

Boston Scientific AXIOS and HOT AXIOS Stent and Delivery Systems

The device has increased reports of stent deployment and expansion issues.

High risk, FDA, Device defect

Wilson-Cook Nasal Jejunal Feeding Tube

The nasal jejunal feeding tube is packaged without the nasal transfer tube component.

Moderate risk, FDA, Device defect

2 recalls that day

Changchun Wancheng Bio-Electron Urine Test Strips and Cassettes

The test strips were distributed before they could be legally marketed.

Moderate risk, FDA, Device defect

Vortex Surgical Ophthalmic Surgical Instruments

Vortex Surgical Ophthalmic Surgical Instruments may have voids in the seal of Tyvek pouches, potentially leading to infection.

Moderate risk, FDA, Sterility problem