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
Dec 28, 2023

Philips North America LLC Recalls Panorama 1.0T HFO MRI due to a Risk of Explosion During a Quench Procedure Caused by Excessive Pressure Buildup of Helium Gas

Source: FDA MedWatch

Device- Warning
Dec 28, 2023

Eitan Medical Ltd Recalls Sapphire Infusion Pumps for Failure to Detect Air in the Line

Source: FDA MedWatch

Device- Cautionary Notice
Dec 13, 2023

CareFusion 303 Recalls Alaris PCA, PCU and Syringe Module Infusion Pumps for Device Labeling Correction on Compatibility Syringe

Source: FDA Medical Device Recalls

Device- Cautionary Notice
Dec 13, 2023

Baxter Healthcare Corporation Recalls Novum IQ Syringe Pump for Potential Underdosing

Source: FDA MedWatch

Device- Cautionary Notice
Dec 13, 2023

Becton Dickinson & Company Recalls BD Alaris Pump Infusion Sets, Extension Sets and Gravity Sets (Multiple Models) for Labeling Errors

Source: FDA Medical Device Recalls

Drug- Cautionary Notice
Dec 13, 2023

Exela Pharma Issues Voluntary Nationwide Recall of 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL, Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL, and ELCYS (cysteine hydrochloride Injection), USP 500 mg/10 mL Due to the Presence of Particulate Matter

Source: FDA MedWatch

Drug- Cautionary Notice
Dec 13, 2023

Nurse Assist, LLC Issues Recall of 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP Nationwide and to Canada

Source: FDA MedWatch

Device- Warning
Dec 13, 2023

Musculoskeletal Transplant Foundation Recalls DBX Demineralized Bone Matrix Putty for Volume Mislabeling

Source: FDA Medical Device Recalls

Drug- Warning
Dec 13, 2023

Hospira Issues Voluntary Nationwide Recall - 4.2% Sodium Bicarbonate Injection, USP & 1%, 2% Lidocaine HCl Injections, USP due to Potential for Presence of Glass Particulate Matter

Source: FDA MedWatch

Drug- Cautionary Notice
Dec 04, 2023

Lugols Iodine Solution 500 mL Recalled for improper seal

Source: FDA Medical Device Database

Device- Cautionary Notice
Nov 06, 2023

DiagnsosUS SARS CoV-2 Antibody (IgG/IgM) Test Recall

Source: FDA Medical Device Recalls

Device- Cautionary Notice
Nov 03, 2023

Philips Respironics Recalls V60 and V60 Plus Ventilators due to Power Management Printed Circuit Board Assemblies (PM PCBAs) Not Meeting Ventilator Standards

Source: FDA MedWatch

Device- Cautionary Notice
Nov 03, 2023

UPDATE - Hamilton C1, C2, C3 & T1 Ventilators & now MR-1 recalled for Capacitator Leaks and Short Circuits

Source: FDA MedWatch

Device- Cautionary Notice
Nov 03, 2023

ResMed Ltd. Recalls - Astral 100 and Astral 150 Ventilators

Source: FDA Medical Device Recalls

Device- Warning
Nov 02, 2023

B. Braun Medical, Inc. Recalls: Infusomat Large Volume Infusion Pumps (Multiple Products)

Source: FDA Medical Device Recalls

Device- Warning
Nov 01, 2023

Cardinal Health Recalls: Monoject Syringe Luer-Lock Tip Soft Packs (Multiple Sizes)

Source: FDA Medical Device Recalls

Device- Alert
Oct 31, 2023

Medline Industries Recalls Hudson RCI Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution Due to Being Non-Sterile

Source: FDA MedWatch

Device- Alert
Oct 31, 2023

Medtronic Sofamor Danek USA Recalls: Grafton Demineralized Bone Matrix (DBM) Crunch, Flex, Putty, Orthoblend, Paste, Strips

Source: FDA Medical Device Recalls

Device- Warning
Sep 29, 2023

Alphatec Spine Recalls: LIF AMP™ (Anti-Migration Plate) Adjustable Awl

Source: FDA Medical Device Recalls

Drug- Cautionary Notice
Sep 26, 2023

Medtronic Sofamor Danek Recalls: Magnifuse Bone Graft - Demineralized Bone Matrix

Source: FDA Medical Device Recalls

Device- Cautionary Notice
Sep 26, 2023

Recall: Mallinckrodt One-Way Valve used with Ventilators due to valve potential to stick and prevent or reduce flow of ventilated oxygen

Source: FDA Medical Device Recalls

Device- Cautionary Notice
Sep 25, 2023

Abbott Medical Recalls Implantable Pulse Generators Proclaim XR 5, XR 7, DRG, Plus 5, Plus 7 & Infinity 5, 7 used for spinal cord stimulation

Source: FDA Medical Device Recalls

Device- Warning
Sep 22, 2023

Recall of Medline Probe Cover Kits due to inadequate barrier at seams - includes Spinal Epidural Anesthesia, Diagnostic Ultrasound Procedures, Universal Insertion Tray/PPE bundle, IV start kits and Nerve block, Peds anesthesia, Ortho, Gen Surg, Dressing Change Trays

Source: FDA Med. Device Recalls

Device- Cautionary Notice
Sep 20, 2023

Urgent Medical Device Correction: Medfusion Model 3500, 4000 Syringe Infusion Pumps

Source: Smiths Medical

Device- Cautionary Notice
Sep 20, 2023

3M Recalls Super Rapid Readout Biological Indicators and Super Rapid 5 Steam-Plus Challenge and Super Rapid Readout Steam Challenge

Source: Ethicon, Inc.

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