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FDA medical device recalls

Medical device recalls from FDA, newest first. 876 recalls Each recall is dated by the day its recall page names (how recalls are dated).
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6 recalls that day

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

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

High risk, FDA, Device defect

Cardinal Health Monoject Tuberculin Syringes

Packages labeled as Tuberculin Syringes contain U-100 Insulin syringes.

Moderate risk, FDA, Labeling error

3 recalls that day

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 Sensors and Needle System Starter Kits may identify the needle tip position incorrectly on the user interface.

Moderate risk, FDA, Software defect

Baxter Volara Ventilator Adapter Modules

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

High risk, FDA, Device defect

1 recall that day

Abiomed Purge Cassettes and Impella Pump Sets

Purge Cassette has an increased risk of purge leaks.

High risk, FDA, Device defect

5 recalls that day

Synthes 2.4 Volt Tap Locking and Cortex Screws

2.4 Volt TAP Locking Screw TAP to 90MM and 2.4 Volt(TM) TAP Cortex Screw to 90MM have an incorrect thread due to a lot swap.

Moderate risk, FDA, Device defect

Olympus SOLTIVE Premium and Pro Laser Systems

The Soltive laser systems may become inoperable due to a power supply defect, and smoke or a burning smell may occur.

Moderate risk, FDA, Device defect

Da Vinci S and Si Endoscopic Instruments

Da Vinci S and Si reusable instruments have broken or frayed grip cables.

Moderate risk, FDA, Device defect

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 balloon in the device may not meet burst specifications.

Moderate risk, FDA, Device defect

14 recalls that day

Mentor Breast Tissue Expanders

Mentor 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

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 may have modules unreachable after a reboot, causing delays in 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 and Medline kits containing it may not seal properly, which could lead to leakage.

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

A software defect in the RefleXion X1 Radiotherapy System can cause the treatment plan dose to be delivered to the 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 assembly may not adequately support the weight of the ceiling cover.

Moderate risk, FDA, Device defect

ReCor Medical Paradise Ultrasound Renal Denervation Catheters

The Paradise Ultrasound Renal Denervation System 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, which may cause a strong inflammatory response.

Moderate risk, FDA, Contamination

Atellica CH Enzymatic Hemoglobin A1c (A1c_E)

Atellica CH Enzymatic Hemoglobin A1c may give depressed results when used with another assay on the same analyzer.

Moderate risk, FDA, Device defect

3 recalls that day

Philips Respironics Trilogy Evo Ventilators

Using non-pneumatic nebulizers with these 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

A design defect may cause the sheath introducer not to split as intended.

High risk, FDA, Device defect

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

The labeling does not say which security version hospital networks must enable for secure Wi-Fi communication with Point-of-Care Units.

Moderate risk, FDA, Labeling error

2 recalls that day

Olympus Cutting Forceps

Defective welds can result in the jaw breaking during clinical 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.

Moderate risk, FDA, Device defect

6 recalls that day

OrthAlign Lantern Knee System Drill Plates

Drill plates are manufactured out of specification.

Moderate risk, FDA, Quality testing problem

Medtronic MiniMed 780G Insulin Pumps

The software defects could result in a risk of hypoglycemia or hyperglycemia due to inaccuracies in insulin delivery.

Moderate risk, FDA, Software defect

Straumann Custom Abutments

A material mix-up occurred during manufacturing, and some abutments were made from TAN material instead of titanium.

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 the lens from unfolding consistently.

Moderate risk, FDA, Device defect

BiDop 3 Pocket Doppler Blood-Flow Detectors

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

Moderate risk, FDA, Unapproved product

Philips Ultrasound Transducers

The notice provides clarification and labelling to define the useful life of ultrasound transducers in the field.

Low risk, FDA, Labeling error

1 recall that day

Handy Solutions Neck & Shoulders Heating Pad

The heating pad can cause excessive temperatures when folded or placed under the body, potentially causing burns.

High risk, FDA, Device defect

5 recalls that day

I.T.S. Orthopedic Plates and Screws

I.T.S. Orthopedic Plates and Screws may cause higher RF-induced temperature increases under certain MRI conditions.

Moderate risk, FDA, Device defect

Erbe Flexible Cryoprobes

Erbe is recalling its Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath and Flexible Cryoprobe because Probes may rupture/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

The Imactis CT-Navigation System can lead to discordance between simulated and actual needle trajectory.

Moderate risk, FDA, Device defect

Beckman Coulter MicroScan Neg MIC 56 Panels

MicroScan Neg MIC 56 panels may be contaminated in some wells.

Moderate risk, FDA, Contamination

7 recalls that day

Datascope Battery Charging Station

The Battery Charging Station has a protruding screw that limits battery insertion and prevents proper charging.

Low risk, FDA, Device defect

Leksell Gamma Knife

Due to adapter not being 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 may 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 that day

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