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Medical device recalls

Medical device recalls from FDA, newest first.
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4 recalls

ConvaTec EsteemBody Drainable Pouches

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

Moderate risk, FDA, Manufacturing problem

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

1 recall

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

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

4 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 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

3 recalls

International Life Sciences Artelon FlexBand Dynamic Matrix and FlexBand Plus

Artelon FlexBand devices failed bacterial endotoxin testing.

Moderate risk, FDA, Contamination

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

2 recalls

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

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

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

3 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

1 recall

Atellica CH Urine Albumin (UAlb)

Atellica CH Urine Albumin may report falsely depressed results for samples above 40.0 mg/dL.

Moderate risk, FDA, Device defect

4 recalls

Impella RP

The Impella RP devices have a sensor that 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

The viewer may show patient information that does not match the images displayed.

Moderate risk, FDA, Device defect

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

The ShockPulse-SE Lithotripsy System can remain in a blinking phase waiting to recognize the transducer due to damage to the plug or receptacle.

Moderate risk, FDA, Device defect

2 recalls

Medtronic Octopus Nuvo Tissue Stabilizer

The Octopus Nuvo Tissue Stabilizer has tubing incorrectly positioned, which may cause assembly issues.

Moderate risk, FDA, Manufacturing problem

Agiliti Adapt Pump

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

Moderate risk, FDA, Device defect

1 recall

Medline Kits with Tego Connectors

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

Moderate risk, FDA, Contamination

4 recalls

Medline Sterile Saline Wound Wash and Convenience Kits

Medline Sterile Saline Wound Wash may not meet sterility requirements.

Moderate risk, FDA, Sterility problem

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 have a ceramic tip that may break.

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

1 recall

Olympus High Flow Insufflation Unit

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

High risk, FDA, Software defect

3 recalls

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

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

The Molli 2 System needs updated labeling because magnetized surgical tools can dislodge markers during tissue removal.

Moderate risk, FDA, Labeling error

Olympus Thunderbeat Surgical Devices

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

Moderate risk, FDA, Device defect

2 recalls

Bard Broviac Single-Lumen CV Catheter Cutdown Tray

The Broviac catheter tray has damage to its 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, causing treatment delays, blood loss, infection, air embolism, or underdosage.

Moderate risk, FDA, Device defect

1 recall

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

2 recalls

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

2 recalls

Straumann WB Impression Post Closed Tray

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

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

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

Spectral CT 7500 on Rails may have fasteners not torqued to specification, potentially causing rotor parts to become unsecured and expelled.

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.

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

4 recalls

Olympus Sphincterotomes

Single Use 3-Lumen Sphincterotome V devices may deform and lose performance.

Moderate risk, FDA, Device defect