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Medical device recalls

Medical device recalls from FDA, newest first.
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6 recalls

Medtronic MiniMed 780G Insulin Pumps

The MiniMed 780G insulin pump with software versions 6.60 and 6.61 has software defects that could cause hypoglycemia or hyperglycemia.

Moderate risk, FDA, Software defect

Straumann Custom Abutments

A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments.

Moderate risk, FDA, Manufacturing problem

TECNIS Eyhance IOL with TECNIS Simplicity Delivery System

The TECNIS Eyhance IOL may have a haptic that sticks to the optic, preventing consistent unfolding.

Moderate risk, FDA, Device defect

BiDop 3 Pocket Doppler Blood-Flow Detectors

The BiDop 3 Pocket Doppler has a fetal indication for use that is not cleared.

Moderate risk, FDA, Unapproved product

Philips Ultrasound Transducers

Philips ultrasound transducers lack labelling to define their useful life.

Low risk, FDA, Labeling error

1 recall

Handy Solutions Neck & Shoulders Heating Pad

The heating pad can cause burns to persons and property if folded or placed under the body.

High risk, FDA, Device defect

5 recalls

I.T.S. Orthopedic Plates and Screws

Volar Radius Plate with Angular Stability may cause higher temperature increases under certain MRI conditions.

Moderate risk, FDA, Device defect

Erbe Flexible Cryoprobes

Flexible Cryoprobes may rupture or burst during activation.

High risk, FDA, Device defect

Olympus Endoscope Valves and Reprocessors

The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

Moderate risk, FDA, Device defect

GE Medical Systems Imactis CT-Navigation Systems

There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.

Moderate risk, FDA, Device defect

Beckman Coulter MicroScan Neg MIC 56 Panels

MicroScan panels may be contaminated in some wells.

Moderate risk, FDA, Contamination

7 recalls

Datascope Battery Charging Station

The Battery Charging Station has a protruding screw that prevents proper charging of certain batteries.

Low risk, FDA, Device defect

Leksell Gamma Knife

The Leksell Gamma Knife has an adapter that may not be properly aligned or locked in place.

Moderate risk, FDA, Device defect

Artegraft Vascular Graft

The Artegraft Vascular Graft has a labeling mix-up resulting in incorrect lot outer packaging.

Moderate risk, FDA, Labeling error

ConvaTec EsteemBody Drainable Pouches

Convatec EsteemBody Drainable Pouch may leak due to a manufacturing issue.

Moderate risk, FDA, Manufacturing problem

Aptima HPV Assay

The Aptima HPV Assay can generate invalid or false negative results.

Moderate risk, FDA, Device defect

Stryker Cub Pediatric Crib

The Cub Pediatric Crib is missing two access door warning labels.

Moderate risk, FDA, Labeling error

STA Liatest D-Di

After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.

Moderate risk, FDA, Device defect

2 recalls

Howmedica Osteonics MICS3 Angled Sagittal Saw Attachment

The MICS3 Angled Sagittal Saw Attachment has screws that may loosen and detach during use.

Moderate risk, FDA, Device defect

Welch Allyn Spot Vision Screener VS100

The Welch Allyn Spot Vision Screener VS100 may have a flickering display that can cause seizures in susceptible people.

Moderate risk, FDA, Software defect

1 recall

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

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

Insulet Omnipod 5 Pods

Omnipod 5 Pods may have a tear causing 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 chest drainage units have updated instructions to clarify they are for adults only.

Moderate risk, FDA, Device defect

Medline Medcrest Surgical Gowns and Surgical Drapes

Medline Medcrest Surgical Gowns may experience premature delamination, which can cause 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 GmbH is recalling its Wondfo Streptococcal A At-Home Self-Test, Clearest Strep-A Cassette Test, and Bisaf Strep A Self-Test because of product not cleared by the FDA.

Moderate risk, FDA, Unapproved product

4 recalls

International Life Sciences Artelon FlexBand Dynamic Matrix and FlexBand Plus

Artelon FlexBand devices failed bacterial endotoxin testing.

Moderate risk, FDA, Contamination

Beckman Coulter 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

Alarms from the primary patient bedside monitor may not be transmitted or received on the remote system.

Moderate risk, FDA, Device defect

EndoVive Safety PEG Kit

The EndoVive Safety PEG Kit contains ChloraPrep Triple Swabsticks with open or compromised seals.

Moderate risk, FDA, Sterility problem

4 recalls

Waldemar Link Endo-Model Replacement Plateaus and Connection Components

Endo-Model Replacement Plateau and SL Connection Components may have a bushing that detaches from the screw shaft.

Moderate risk, FDA, Device defect

GEM Premier 5000

GEM Premier 5000 PAK may experience increased Process Control Solution Not Detected errors during warm-up, causing ejection and delays.

Moderate risk, FDA, Device defect

Physio-Control Infant/Child Reduced Energy Defibrillation Electrodes

Infant/Child Reduced Energy Defibrillator Electrodes may delaminate, which can affect defibrillation.

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

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

Raz Mobile Shower Commode Chairs

Mobile shower commode chairs may be reinstalled without properly engaging the outside rear seat brackets that keep the seat in place.

Moderate risk, FDA, Device defect

Medline Unna-Z Stretch Zinc Paste Bandage

The zinc paste bandage has a labeling error with incomplete ingredients listed.

Moderate risk, FDA, Labeling error

BD 10mL Luer-Lok Tip Syringes

The syringe may contain Luer Slip syringes instead of Luer Lok.

Moderate risk, FDA, Device defect

IBA Proton Therapy System - PROTEUS 235

The IBA Proton Therapy System - PROTEUS 235 has a disabled beam triggering interface, which may lead to mistreatment.

Moderate risk, FDA, Device defect

2 recalls

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

Vascutek Gelsoft Plus and Gelweave Vascular Grafts

Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life.

Moderate risk, FDA, Labeling error

4 recalls

Olympus Single Use Biopsy Valve

The Olympus Single use Biopsy Valve can detach rubber fragments during use.

Moderate risk, FDA, Foreign object

Datascope CS100 and CS300 Intra-Aortic Balloon Pumps

The CS100 Iabp and CS300 Iabp have battery runtime and cycle specifications that need to be updated.

Moderate risk, FDA, Device defect

STA Liatest Free Protein S

The STA Liatest Free Protein S kit may show 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

B. Braun 21G Winged Infusion Sets

B. Braun winged infusion sets may have a dull or blunt needle tip that can be difficult to advance or break.

Moderate risk, FDA, Device defect

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

The lens is labeled as 12.1 mm but is 12.6 mm, which may cause excessive vault.

Moderate risk, FDA, Labeling error