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FDA medical device recalls

Medical device recalls from FDA, newest first. 876 recalls Each recall is dated by the day its recall page names (how recalls are dated).
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7 recalls that day

Merge OrthoPACS and PACS

Thumbnails from a previously opened patient study may be displayed while a different patient study is open.

Moderate risk, FDA, Device defect

Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls

The Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls have too much sodium azide, which can cause mild skin or eye irritation.

Low risk, FDA, Quality testing problem

Syva Emit Disopyramide Assay Enzyme Immunoassay

The Syva Emit Disopyramide Assay has too much sodium azide in one lot, which can cause mild skin or eye irritation.

Low risk, FDA, Quality testing problem

Happiest Baby Pre-Loved SNOO Smart Sleeper

Refurbished bassinets failed to meet quality standards prior to distribution.

Moderate risk, FDA, Device defect

7 recalls that day

Maquet Critical Care Flow Anesthesia Machines

The Flow Anesthesia Machine may fail to deliver anesthetic agent when the vaporizer is activated.

Moderate risk, FDA, Device defect

Zimmer Biomet Intramedullary Bone Saw Blade Assembly

The Intramedullary Bone Saw Blade Assembly may have damaged sterile barrier packaging due to an exposed saw blade.

Moderate risk, FDA, Sterility problem

Stryker Ahto Tube Sets and Suction/Irrigator Packaging

Stryker Ahto Tube Sets and Suction/Irrigator Packaging can leak from the handpiece during use.

Moderate risk, FDA, Device defect

Medical Action Industries Dialysis Change Tray Clear Sequence

The Dialysis Change Tray Clear Sequence contains a needle free access device with an improper seal that may cause doming or tearing of the silicone seal.

Moderate risk, FDA, Device defect

OXOS Medical MC2 Portable X-Ray System

The MC2 Portable X-Ray System has a defective circuit board that overheats.

Moderate risk, FDA, Device defect

Innovasis Vector Pedicle Screw System Anti-Torque

The anti-torque instrument may have an undersized condition, preventing engagement with the pedicle screw tulip and rod during tightening.

Moderate risk, FDA, Device defect

Nuclein DASH Rapid PCR Instrument

The DASH Rapid PCR Instrument may show false co-infection results due to a software issue.

Moderate risk, FDA, Software defect

9 recalls that day

Halyard Cardiac Catheterization and Angiography Kits

The kits contain manifolds with particulates in the fluid path.

High risk, FDA, Foreign object

Munevo DRIVE and Munevo DRIVE R-Net Powered Wheelchair Hands-Free Control Application

A software issue may cause the wheelchair's driving mechanism to fall out of calibration, leading to unexpected steering drift or imprecise control.

Moderate risk, FDA, Software defect

THERANICA BIOELECTRONICS Nerivio Infinity

Nerivio Infinity may have a thermal-runway event during charging, causing smoke and odor.

Moderate risk, FDA, Device defect

Copan WASPLab Automated Culture Plate Incubators and Imagers

WASPLab has a software issue that may prevent users from overwriting results.

Moderate risk, FDA, Software defect

Boston Scientific Radial Jaw 4 Biopsy Forceps

Boston Scientific Radial Jaw 4 Biopsy Forceps may have a breach in the sterile barrier of their packaging.

Moderate risk, FDA, Sterility problem

FORWARD Oral Airway Kit and Kingfisher Compact Individual First Aid Kit

The device could potentially contain an occluded or partially occluded Guedel Airway tip.

Moderate risk, FDA, Device defect

Quantum Rehab Power Wheelchairs

Quantum Rehab powered wheelchairs may show reminder pop-ups while in use, causing unexpected stops or crashes.

Moderate risk, FDA, Device defect

Charger for the Therabody Theragun, G4 PRO Massage Device

The charger for the Theragun G4 Pro may overheat, posing a fire risk.

Moderate risk, FDA, Device defect

Normand Info REMISOL Advance Data Manager

Remisol Advance with Software Version 2.5 may replace a final combo test result with a sub-result, causing incorrect reporting.

Moderate risk, FDA, Software defect

3 recalls that day

Bard Access Systems BD Needle Kit for Powered Driver

BD Needle Kit for Powered Driver may have difficulty removing the obturator, potentially causing delayed therapy.

High risk, FDA, Device defect

Terex Utilities Power Over Fiber Base Module

The Power Over Fiber Base Module is not certified and is improperly labeled.

Moderate risk, FDA, Unapproved product

Medical Action Industries Medline Angiographic Manifold Packs

Cardiovascular procedure kits contain manifolds that may have particulate within the fluid path.

High risk, FDA, Foreign object

2 recalls that day

Stryker Hoffmann II Connecting Rod Micro

Stryker Hoffmann II Connecting Rod Micro may crack following cleaning and sterilization.

Moderate risk, FDA, Device defect

Instrumentation Laboratory GEM Premier 5000 and GEM Premier 7000 Blood Analyzers

GEM Premier blood analyzers with BCR wands may assign patient results to the wrong patient ID, potentially leading to inappropriate clinical management.

Moderate risk, FDA, Device defect

2 recalls that day

SeaSpine OsteoBallast and Ballast Bone Grafts

The products were filled with approximately 4.5 cc of demineralized bone matrix instead of approximately 7.5 cc.

Moderate risk, FDA, Device defect

ResMed Astral 100 and 150 Ventilators

The Resmed Astral ventilator system can fail due to electrolyte leakage, interrupting ventilation therapy.

High risk, FDA, Device defect

3 recalls that day

Philips CT Scanners

The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually.

Moderate risk, FDA, Device defect

AMS Aligned Medical Solutions Medical Convenience Kits

AMS medical convenience kits contain Elevaris Lidocaine HCl injection USP with supplier quality issues.

Moderate risk, FDA, Packaging defect

Medtronic Perfusion Systems EOPA Arterial Cannulas

EOPA arterial cannulae may have pinhole leaks in the wire-wound body during cardiopulmonary bypass.

Moderate risk, FDA, Device defect

4 recalls that day

Argon Medical Devices L-Cath Catheters

Argon Medical Devices L-Cath Catheters may leak or crack at the hub, leading to blood loss and infection.

Moderate risk, FDA, Device defect

AMS Aligned Medical Solutions Surgical Procedure Packs

AMS Aligned Medical Solutions medical convenience kits may have unexpected variability of endotoxin levels.

Moderate risk, FDA, Sterility problem

Permobil M5 Corpus Power Wheelchair

The M5 Corpus Power Wheelchair may drive under restricted conditions and create an unstable condition.

Moderate risk, FDA, Software defect

Permobil M3 Corpus Power Wheelchair

The Permobil M3 Corpus Power Wheelchair may tip over or cause falls when the seat lift exceeds 50 mm.

Moderate risk, FDA, Software defect

6 recalls that day

Medline Medical Convenience Kits

Medline medical convenience kits may be contaminated with low levels of Bacillus species.

Moderate risk, FDA, Contamination

Medline Convenience Kits Containing Bard Silastic Foley Catheters

Medline convenience kits containing Bard Silastic Foley Catheters may have increased raw material on the surface, which may be harmful.

Moderate risk, FDA, Device defect

Medline Hip and Knee Procedure Kits

The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP.

High risk, FDA, Device defect

MiniMed Go App

The MiniMed Go App may not trigger nighttime alerts, leading to missed insulin doses and increased hyperglycemia risk.

Moderate risk, FDA, Software defect

Karl Storz Endoscopy Flexible Hystero-Fiberscope Kits

Flexible Hystero-Fiberscope Kits may contain an expired seal, impacting sterility assurance.

Moderate risk, FDA, Sterility problem

SafeOp Patient Interface

The device may experience loss or interruption of triggered electromyography (tEMG) functionality during use.

Moderate risk, FDA, Software defect

7 recalls that day

SnapshotGLO Wound Imaging Device

The SnapshotGLO Wound Imaging Device may not resume charging after a battery fully discharges, becoming temporarily unusable.

Moderate risk, FDA, Software defect

Pipeline Flex Embolization Device with Shield Technology

Pipeline Flex Embolization Device with Shield Technology is mislabeled, with 12 mm and 20 mm implants swapped.

Moderate risk, FDA, Labeling error

Medline Convenience Kits

The kits contain Bupivacaine Hydrochloride in Dextrose Injection, which has quality issues.

High risk, FDA, Device defect

Halyard Standard Line Insertion Pack

The Halyard Standard Line Insertion Pack has defective silicone seals that may cause fluid occlusion or leakage.

Moderate risk, FDA, Device defect

Emano Flow

The problem usually over-reports flow rate and volume; the firm have made corrected results available to care teams.

Moderate risk, FDA, Device defect

Boston Scientific TheraSphere 360 Y-90 Management Platform

A software anomaly occurs when a user adds vials to the cart and then modifies an input.

Moderate risk, FDA, Software defect

Olympus High Flow Insufflation Unit - UHI-4

The front panel display can turn off unexpectedly, and air delivery ceases.

Moderate risk, FDA, Device defect

5 recalls that day

Medtronic Neurosurgery Ventriculostomy Kit

Ventriculostomy kits may have endotoxin levels above the acceptable limit, causing an acute inflammatory process.

Moderate risk, FDA, Contamination

Penumbra System RED 68 Reperfusion Catheter

The Penumbra System RED 68 Reperfusion Catheter may fracture due to manufacturing issues.

Moderate risk, FDA, Manufacturing problem

Wilcox BOSS Xe Family

The BOSS Xe family has a software enhancement to increase safety.

Moderate risk, FDA, Software defect