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Medical device recalls

Medical device recalls from FDA, newest first.
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7 recalls

Atellica CH Enzymatic Hemoglobin A1c (A1c_E)

Atellica CH Enzymatic Hemoglobin A1c (A1c_E) may show depressed results when used with RCRP on the same analyzer, potentially delaying diabetes diagnosis.

Moderate risk, FDA, Device defect

3 recalls

Philips Respironics Trilogy Evo Ventilators

Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.

High risk, FDA, Device defect

Merit Medical Hemodialysis Catheters and Sheath Introducer

Hemodialysis catheters and a sheath introducer may not split as intended.

High risk, FDA, Device defect

BD Alaris System with Guardrails Suite MX with Point of Care Unit

The BD Alaris System with Guardrails Suite MX with Point of Care Unit lacks labeling for secure Wi-Fi communication.

Moderate risk, FDA, Labeling error

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

4 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

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

4 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

4 recalls

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

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

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

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

2 recalls

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

Encore Medical Reverse Shoulder Prosthesis and EMPOWR 3D Knee Inserts

Knee and humeral socket implants contain incorrect labeling.

Moderate risk, FDA, Labeling error

3 recalls

Medline Sterile Saline Wound Wash and Convenience Kits

Medline Sterile Saline Wound Wash may not meet sterility requirements.

Moderate risk, FDA, Sterility problem

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

4 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

Auris Health MONARCH Bronchoscopy Platform

Monarch Platform, Bronchoscopy has a software issue that may cause unanticipated robotic arm positioning.

Moderate risk, FDA, Software defect

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