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Medical device recalls

Medical device recalls from FDA, newest first.
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1 recall

Olympus Cutting Forceps

The cutting forceps have defective welds that can cause the jaw to break during use.

Moderate risk, FDA, Device defect

2 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

Philips Ultrasound Transducers

Philips ultrasound transducers lack labelling to define their useful life.

Low risk, FDA, Labeling error

3 recalls

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

3 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

2 recalls

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

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

1 recall

Penner Pacific Bathing Spas

The Penner Pacific Bathing Spa lacks a unique device identifier.

Low risk, FDA, Device defect

1 recall

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

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

2 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

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

1 recall

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

3 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

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

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

4 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

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