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Medical device recalls

Medical device recalls from FDA, newest first.
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5 recalls

LinkBio CORE Workstation

The LinkBio CORE Workstation may display an incorrect planning date on the start case menu screen.

Moderate risk, FDA, Device defect

Philips AneurysmFlow

Philips AneurysmFlow software may not provide reliable prognostic information about aneurysm occlusion after Flow Diverter Stent treatment.

Moderate risk, FDA, Device defect

Arjo Tenor Mobile Passive Patient Lift

The Arjo Tenor mobile passive patient lift has an internal actuator component that may not meet required mechanical strength.

Moderate risk, FDA, Device defect

Beta Bionics iLet Ace Pump Kit and Dosing Decision Software

The iLet Ace Pump Kit and Dosing Decision Software can be bypassed, allowing unauthorized access and potentially causing severe hypoglycemia.

Moderate risk, FDA, Device defect

1 recall

Stryker Sustainability Solution Color Cuff

The tourniquet cuffs can detach from the bladder at the welding connection.

Moderate risk, FDA, Device defect

2 recalls

Brahms B.R.A.H.M.S PlGF Plus KRYPTOR Diagnostic Test

The B.R.A.H.M.S PlGF Plus Kryptor test may show out-of-range quality control values, potentially leading to falsely elevated sFlt-1/PlGF ratio results.

Moderate risk, FDA, Device defect

Beckman Coulter MicroScan Neg Multidrug Resistant MIC 1 Panels

MicroScan Neg Multidrug Resistant MIC 1 has a manufacturing issue with in vitro multidrug resistant test.

Moderate risk, FDA, Manufacturing problem

3 recalls

Medline Namic Angiographic Control Syringes and Medical Convenience Kits

NAMIC Angiographic Rotating Adaptor (RA) Control Syringes may unwind during use, causing a loose or full disconnection.

High risk, FDA, Device defect

Siemens Artis Pheno and Artis Icono Biplane Systems

ARTIS pheno and ARTIS Icono biplane, floor and ceiling may sporadically display a major increase of the x-ray dose applied to the patient.

Moderate risk, FDA, Device defect

Spacelabs Healthcare Multi-Parameter Command Module

The Multi-parameter Command Module has a circuit board issue that may cause inaccurate readings and delayed care.

Moderate risk, FDA, Device defect

2 recalls

Cook Medical Guide Wires, Catheter Sets and Trays

Cook Medical devices were labeled with expiration dates that exceed their true shelf life.

Moderate risk, FDA, Labeling error

Molded Products Luer Cap Sets

The See Luer Cap Set has a threaded sleeve that may not be engaged and can become unattached.

Moderate risk, FDA, Device defect

3 recalls

XTANT Medical Xpress Pedicle Screw System

The Xpress Pedicle Screw System was mislabeled with an incorrect part number, identifying it as shorter than it is.

Moderate risk, FDA, Labeling error

Tornier HRS Max Tuberosity Bodies and Trial

Tornier HRS Max parts were incorrectly labeled and are incompatible with the HRS Max system.

Moderate risk, FDA, Labeling error

Beckman Coulter MicroScan Neg MIC 3J

MicroScan Neg MIC 3J is missing a drug in well 4/4 but contains double the amount of antibiotics.

Moderate risk, FDA, Manufacturing problem

6 recalls

GE Healthcare SIGNA Premier Systems

SIGNA Premier systems, whole-body MR scanners, may have ferrous fittings that could attract and cause injury during service.

Moderate risk, FDA, Device defect

Medtronic MiniMed and Paradigm Insulin Pumps

Over-delivery can cause severe hypoglycemia, altered mental status, seizure, coma, or death.

Moderate risk, FDA, Device defect

Burlington Medical Radiation Protection Apparel

Burlington Medical BAT Coverage may degrade over time, decreasing its lifespan.

Moderate risk, FDA, Device defect

Oxoid Microbact Identification Kits Listeria 12L Kit

Oxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A lot 4494873 may identify incorrect organism due to inconclusive result from ambiguous color reactions in wells.

Moderate risk, FDA, Device defect

Philips Respironics Trilogy EV300, Evo, Evo O2, and Evo Universal

In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

High risk, FDA, Device defect

Cardinal Health Monoject Tuberculin Syringes

The outer packaging and blister pack label the product as a 1mL Luer Lock Tuberculin Syringe, but the syringes inside are U-100 Insulin syringes.

Moderate risk, FDA, Labeling error

3 recalls

Medline Bronchoscopy and Airway Kits

Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves.

Moderate risk, FDA, Foreign object

eTRAX Needle Sensor and System Starter Kit

The eTRAX Needle System Starter Kit has an error in inspection and programming, potentially causing incorrect needle tip position on the interface.

Moderate risk, FDA, Software defect

Baxter Volara Ventilator Adapter Modules

The Blue Ventilator Adapter Module may cause unawareness of oxygen desaturation or barotrauma in home care.

High risk, FDA, Device defect

1 recall

Abiomed Purge Cassettes and Impella Pump Sets

Purge Cassette has an increased risk of purge leaks.

High risk, FDA, Device defect

5 recalls

Synthes 2.4 Volt Tap Locking and Cortex Screws

Bone taps have an incorrect thread due to a lot swap.

Moderate risk, FDA, Device defect

Olympus SOLTIVE Premium and Pro Laser Systems

The Soltive Pro and Premium laser systems may become inoperable and emit smoke or a burning smell.

Moderate risk, FDA, Device defect

Intuitive Surgical da Vinci S and Si Endoscopic Instruments

Due to increased complaints for broken/frayed grip cables for reusable instruments.

Moderate risk, FDA, Device defect

Intuitive Surgical da Vinci S, Si Tenaculum Forceps and Permanent Cautery Hook Instruments

The da Vinci S, Si Tenaculum Forceps Instrument has frayed or broken pitch cables.

Moderate risk, FDA, Device defect

Summa Therapeutics Finesse BTK Multicath Injectable Angioplasty Balloon Catheter

The injectable angioplasty balloon catheter may not meet burst specifications.

Moderate risk, FDA, Device defect

14 recalls

Mentor Breast Tissue Expanders

Artoura Breast Tissue Expanders may have infusion sets with dull or blunt needle tips that may be difficult to advance and/or break.

Moderate risk, FDA, Device defect

Philips Allura Xper and Azurion Angiography Systems

Philips Allura Xper and Azurion systems may not initiate X-ray imaging or may do so intermittently when using the wired foot switch.

Moderate risk, FDA, Device defect

BD Kiestra ReadA

The BD Kiestra ReadA can have modules unreachable after a reboot, delaying plate retrieval.

Moderate risk, FDA, Device defect

Automated Impella Controller (AIC)

The Automated Impella Controller may delay its purge system blocked alarm when used with certain pumps.

High risk, FDA, Device defect

Medline Enfit g-Tube Connector

The ENFIT G-TUBE CONNECTOR may not seal properly, leading to leakage that could cause delayed care and fluid loss.

Moderate risk, FDA, Device defect

Waldemar Link Embrace Drill Towers

The Embrace Drill Tower has mixed-up article numbers in the surgical technique overview.

Moderate risk, FDA, Device defect

Ultradent Jiffy Original Composite Polisher Cups

Jiffy Original Composite Polisher Cups may crumble and break apart easily, which could cause a delay in patient treatment.

Moderate risk, FDA, Device defect

RefleXion X1 Radiotherapy System

The RefleXion X1 Radiotherapy System has a software defect that can deliver the treatment dose to an incorrect location.

Moderate risk, FDA, Software defect

Medline Sterile Radiology Procedure Kits

Sterile Radiology Procedure Kits may have a breach in sterile packaging, compromising sterility.

Moderate risk, FDA, Sterility problem

Stryker CHROMOPHARE Softlit Ring Surgical Light System

The surgical light system may not adequately support the weight of the ceiling cover.

Moderate risk, FDA, Device defect

ReCor Medical Paradise Ultrasound Renal Denervation Catheters

The Paradise catheter is nonconforming and not for human use.

Moderate risk, FDA, Unapproved product

Philips Vue Motion V12

Vue Motion V12 may display image frames out of sequence during dynamic cine runs.

Moderate risk, FDA, Device defect

Puracol and Puracol Plus Collagen Wound Dressings

Puracol and Puracol Plus Collagen Wound Dressings have elevated endotoxin levels that may cause strong inflammatory response.

Moderate risk, FDA, Contamination

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

2 recalls

Olympus Cutting Forceps

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

Moderate risk, FDA, Device defect

Tandem Pumps

Tandem pumps have a Czech user guide with translation errors that could lead to unintended insulin delivery and a hypoglycemic event.

Moderate risk, FDA, Device defect

6 recalls

OrthAlign Lantern Knee System Drill Plates

Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm).

Moderate risk, FDA, Quality testing problem