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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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2 recalls that day

Welch Allyn Spot Vision Screener VS100

The Welch Allyn Spot Vision Screener VS100 may flicker on its display screen, potentially inducing photosensitive seizures in susceptible people.

Moderate risk, FDA, Software defect

1 recall that day

Centricity Universal Viewer Software

Centricity Universal Viewer Software has a cybersecurity vulnerability that may expose user login credentials.

Moderate risk, FDA, Software defect

1 recall that day

Abbott Diagnostics Scarborough ID NOW Influenza A & B 2

The ID Now Influenza A & B 2 has a higher occurrence of invalid rates.

Moderate risk, FDA, Device defect

5 recalls that day

Insulet Omnipod 5 Pods

Omnipod 5 Pods have a manufacturing defect that can cause insulin to leak inside, leading to under-delivery or cessation of insulin.

High risk, FDA, Manufacturing problem

Medline Open Heart, Cardiac Procedure and Cardio Congenito Kits

The instructions for use on specified Chest Drainage Units were updated to clarify the intended target patient population as adults.

Moderate risk, FDA, Device defect

Medline Medcrest Surgical Gowns and Surgical Drapes

Medline Medcrest Surgical Gowns and Medline Surgical Drapes may delaminate, causing brief delays in patient care and risk of infection.

Moderate risk, FDA, Device defect

Lutronic CLARITY II Laser System

The Clarity II Laser System can spark or pop and potentially burn patients.

Moderate risk, FDA, Device defect

Altruan Strep A At-Home Self-Tests

Altruan Strep A At-Home Self-Tests are not cleared by the FDA.

Moderate risk, FDA, Unapproved product

4 recalls that day

International Life Sciences Artelon FlexBand Dynamic Matrix and FlexBand Plus

Artelon FlexBand devices failed bacterial endotoxin testing.

Moderate risk, FDA, Contamination

Beckman Coulter Mishima Chemistry Analyzers AU5800 and DxC 700 AU

Beckman Coulter Mishima K.K is recalling its Chemistry Analyzer AU5800 and DxC 700 AU because a delay in results may occur.

Moderate risk, FDA, Software defect

HealthCast "Vital Sync" Remote Patient Monitoring System

The system may not transmit or receive alarms from the primary patient bedside monitor.

Moderate risk, FDA, Device defect

EndoVive Safety PEG Kit

EndoVive Safety PEG Kit may have open or compromised seals on sterile swabstick packaging.

Moderate risk, FDA, Sterility problem

4 recalls that day

Waldemar Link Endo-Model Replacement Plateaus and Connection Components

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Moderate risk, FDA, Device defect

GEM Premier 5000

GEM Premier 5000 may experience increased errors during warm-up, leading to ejection and delayed results.

Moderate risk, FDA, Device defect

Physio-Control Infant/Child Reduced Energy Defibrillation Electrodes

Infant/Child Reduced Energy Defibrillator Electrodes can delaminate.

Moderate risk, FDA, Device defect

Medartis APTUS TriLock Screws

APTUS TriLock Screws may be mixed up between specified lots of 2.5mm and 2.8mm outer diameter screws.

Moderate risk, FDA, Device defect

2 recalls that day

Exactech Equinoxe Ergo and Equinoxe Core Instrument Kits

The Equinoxe Core Instrument Kit and Ergo Modular Impactor Handle may have a missing cross-pin in the impactor handle.

Moderate risk, FDA, Device defect

Penner Pacific Bathing Spas

The Penner Pacific Bathing Spa lacks a unique device identifier.

Low risk, FDA, Device defect

4 recalls that day

Raz Mobile Shower Commode Chairs

These mobile shower commode chairs may have rear seat brackets that are not properly engaged.

Moderate risk, FDA, Device defect

Medline Unna-Z Stretch Zinc Paste Bandage

Medline Unna-Z Stretch Zinc Paste Bandage has a labeling error with incomplete ingredients listed.

Moderate risk, FDA, Labeling error

BD 10mL Luer-Lok Tip Syringes

Some Luer Slip syringes were incorrectly included in a batch of Luer Lok syringes.

Moderate risk, FDA, Device defect

IBA Proton Therapy System - PROTEUS 235

The IBA Proton Therapy System has a disabled beam triggering interface, which may lead to mistreatment when external gating devices are used.

Moderate risk, FDA, Device defect

2 recalls that day

Olympus ShockPulse-SE Lithotripsy System with Generator

The Olympus ShockPulse-SE Lithotripsy System has a mis-wired component that can cause noise and delay treatment.

Moderate risk, FDA, Device defect

Advanced Bionics HiResolution Bionic Ear System Sky CI M90 Sound Processor

The Sky CI M90 Sound Processor has a packaging label that differs from the included product.

Moderate risk, FDA, Labeling error

1 recall that day

Vascutek Gelsoft Plus and Gelweave Vascular Grafts

Gelatin sealed woven polyester prostheses devices were incorrectly labeled with an additional month of shelf life.

Moderate risk, FDA, Labeling error

4 recalls that day

Olympus Single Use Biopsy Valve

The Olympus Single use Biopsy Valve may have rubber fragment detachment during use.

Moderate risk, FDA, Foreign object

Datascope CS100 and CS300 Intra-Aortic Balloon Pumps

The battery runtime and cycle specifications in the instructions for use need to be updated.

Moderate risk, FDA, Device defect

STA Liatest Free Protein S

STA Liatest Free Protein S kits can give out-of-range results and underestimate free protein S levels in normal plasma.

Moderate risk, FDA, Device defect

Esaote Endocavity Ultrasonic Probe E 3-12

The Esaote Endocavity ultrasonic probe may leak liquid from its casing near the cable.

Moderate risk, FDA, Device defect

4 recalls that day

B. Braun 21G Winged Infusion Sets

The needle tip may be dull or blunt, difficult to advance, or break.

Moderate risk, FDA, Device defect

Staar Surgical EVO+ Visian Toric Implantable Collamer Lens (TICL)

The EVO+ Visian Toric Implantable Collamer Lens is labeled as 12.1 mm but is 12.6 mm, which may cause excessive vault and patient discomfort.

Moderate risk, FDA, Labeling error

Aesculap MINOP Trocar

The Minop Trocar 150MM 4 Wking CHANNEL6.0MM has a trocar shaft that may be too long.

Moderate risk, FDA, Device defect

Atellica CH Urine Albumin (UAlb)

Atellica CH Urine Albumin (UAlb) may report falsely depressed patient results.

Moderate risk, FDA, Device defect

4 recalls that day

Impella RP

Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

High risk, FDA, Device defect

Cobas Pro Integrated Solutions with Cobas C 503 analytical Units

The cobas pro integrated solutions with cobas c 503 analytical units have a software defect that can cause erroneous patient results.

Moderate risk, FDA, Software defect

GE Healthcare Centricity Universal Viewer Zero Footprint Client

Patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint Client.

Moderate risk, FDA, Device defect

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