Spine Safety Notices


The North American Spine Society is committed to quality patient care through promotion of patient safety and prevention of medical errors. NASS monitors government and other resources for patient safety-related notices that may be useful to members. Drug and device notices are color coded as yellow (low-impact “Cautionary Notice”), orange (moderate-impact “Warning”), or red (high-impact “Alert”) and will be posted below for up to one year or until the notice expires. This service is provided for information and education only.

Device- Warning
Sep 07, 2023

MEGADYNE Suction Coagulators Recalled: Product issue may lead to fluid ingress into handpiece

Source: FDA Medical Device Recalls

Device- Warning
Sep 06, 2023

Baxter Healthcare Corporation Recalls SIGMA Spectrum Infusion Pumps with Master Drug Library and Spectrum IQ Infusion Systems with Dose IQ Safety Software for Repeat Upstream Occlusion False Alarms

Source: FDA MedWatch

Device- Warning
Sep 06, 2023

GE HealthCare Recalls TruSignal SpO2 Sensors for Issues That May Reduce Defibrillation Energy, Expose Patients to Unintended Voltage, or Give Inaccurate Readings

Source: FDA MedWatch

Device- Cautionary Notice
Aug 31, 2023

Recalled: Hamilton C1, C2, C3 & T1 Ventilators Due to a Software Anomaly That May Cause it to Stop and Enter Ambient Mode Without Prior Notice

Source: FDA Medical Device Recalls

Device- Alert
Aug 14, 2023

URGENT MEDICAL DEVICE RECALL: Medtronic Sofamore Danek - CD Horizon™ Solera™ Spinal System – Awl Tip Tap

Source: FDA Medical Device Recalls

Device- Alert
Aug 14, 2023

Medline Recalls: Custom Sterile & Non-Sterile Procedural Kits Containing Turkuaz Ultrasound Gel, Including Spinal Epidural Anesthesia, Pediatric Anesthesia, Arterial Blood Sampling, Probe Cover, DR MOTT Drape Pack, Laceration, Wound/Change Dressing, IV Start, General/Surgical, Anesthesia CVL Kits

Source: FDA Medical Device Recalls

Device- Cautionary Notice
Jul 24, 2023

Do Not Use RoyalVibe Health, CellQuicken, or Well-Being Reality Ultrasound Medical Devices: FDA Safety Communication

Source: FDA MedWatch

Device- Warning
Jul 24, 2023

NOxBOX Ltd. Recalls NOxBOXi Nitric Oxide System for Manifold Failure that May Cause Gas Leaks and Interrupt Therapy to NeonatesNOxBOX Ltd. Recalls NOxBOXi Nitric Oxide System for Manifold Failure that May Cause Gas Leaks and Interrupt Therapy to Neonates

Source: FDA MedWatch

Device- Warning
Jul 24, 2023

Draeger Medical Recalls Oxylog 3000 Plus Emergency and Transport Ventilators for Risk of Unexpected Depleted Battery and Ventilator Stop

Source: FDA MedWatch

Device- Warning
Jul 18, 2023

Megadyne Recalls MEGA 2000 and MEGA Soft Reusable Patient Return Electrodes for Risk of Serious Burn Injuries to Patients

Source: FDA MedWatch

Drug- Warning
Jul 17, 2023

Aziyo Biologics Announces Voluntary Recall of Viable Bone Matrix Products Due to Reports of Post-Surgical Mycobacterium Tuberculosis (MTB) Infections

Source: Becker's Spine Review

Device- Alert
Jun 30, 2023

Boston Scientific Neuromodulation Corp. Recalls Superion IDS (Indirect Decompression System) Kit - Driver Instructions for Use (IFU)

Source: FDA Medical Device Recalls

Device- Warning
Jun 27, 2023

B. Braun Medical, Inc. Recalls Design Options® & Perifix®/ Epidural Anesthesia Kits

Source: FDA Medical Device Recalls

Device- Alert
Jun 23, 2023

URGENT: MEDICAL DEVICE RECALL Durepair™ Dura Regeneration Matrix – all Lot numbers

Source: Medtronic

Device- Alert
Jun 23, 2023

URGENT: VOLUNTARY MEDICAL DEVICE RECALL PriMatrix®, SurgiMend®, and Revize™

Source: Integra LifeSciences

Drug- Alert
Jun 14, 2023

Fungal Meningitis Outbreak Associated with Procedures Performed under Epidural Anesthesia in Matamoros, Mexico

Source: Centers for Disease Control and Prevention (CDC)

Device- Cautionary Notice
May 26, 2023

ICU Medical Recalls Replacement Batteries for Plum 360, Plum A+, and Plum A+3 Infusion Systems Due to Diminished Battery Life that May Impact Infusion Delivery

Source: FDA MedWatch

Device- Cautionary Notice
Mar 23, 2023

Baxter Issues Urgent Medical Device Correction for LIFE2000 Ventilation System Due to Potential for Patient Desaturation When Connected with an Oxygen Concentrator

Source: FDA MedWatch

Device- Cautionary Notice
Feb 09, 2023

Smiths Medical Recalls Certain CADD System Administration Sets and Cassette Reservoirs for Issues Causing Delay, Interruption, or Under-Delivery of Therapy

Source: FDA MedWatch

Drug- Cautionary Notice
Jan 18, 2023

Accord Healthcare Inc. Issues Nationwide Voluntary Recall of Daptomycin for Injection 500 mg/vial and Daptomycin for Injection 350 mg/vial Lot # R2200232 Due to Product Mix-Up

Source: FDA MedWatch

Drug- Cautionary Notice
Jan 18, 2023

Hospira, Inc. Issues A Voluntary Nationwide Recall For One Lot of Vancomycin Hydrochloride Injection, USP 1.5g/vial, Due To The Presence of Visible Glass Particulates

Source: FDA MedWatch

Device- Warning
Dec 01, 2022

FDA alerts health care professionals of compatibility issues with prefilled glass syringes and certain Luer-activated valve (LAV) connectors

Source: FDA MedWatch