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
Feb 11, 2021

Medfusion 3500 and 4000 Syringe Pumps by Smiths Medical: Class I Recall - Due to Risk of Medication Delivery Error

Source: FDA MedWatch

Drug- Cautionary Notice
Feb 07, 2021

Xeljanz, Xeljanz XR (tofacitinib): Drug Safety Communication - Initial Safety Trial Results Find Increased Risk of Serious Heart-related Problems and Cancer with Arthritis and Ulcerative Colitis Medicine

Source: FDA MedWatch

Drug- Warning
Feb 07, 2021

Enoxaparin Sodium Injection USP by Apotex: Recall - Due to Mislabeling of Syringe Barrel Measurement Markings

Source: FDA MedWatch

Drug- Cautionary Notice
Feb 03, 2021

Cisatracurium Besylate Injection - USP, 10 mg per 5 mL by Meitheal Pharmaceuticals: Recall - Due to Mislabeling

Source: FDA MedWatch

Drug- Warning
Feb 03, 2021

All Alcohol-Based Hand Sanitizers from Mexico: Import Alert - FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S.

Source: FDA MedWatch

Drug- Alert
Jan 12, 2021

Ketorolac Tromethamine Injection USP by Fresenius Kabi: Recall - Due to the Presence of Particulate Matter

Source: FDA MedWatch

Drug- Warning
Jan 07, 2021

Soho Fresh 70% Rubbing Alcohol by Essaar: Recall - Due to Methanol Contamination

Source: FDA MedWatch

Device- Cautionary Notice
Dec 17, 2020

UPDATE: JET 7 Catheters with Xtra Flex Technology by Penumbra: Recall - Due to Increased Risk of Mortality and Serious Injury; JET 7 Catheters with Xtra Flex Technology by Penumbra: Recall - Due to Increased Risk of Mortality and Serious Injury – Urgent Letter to Health Care Providers

Source: FDA MedWatch

Device- Warning
Dec 10, 2020

Wear Face Masks with No Metal During MRI Exams: FDA Safety Communication

Source: FDA Safety Communication

Device- Cautionary Notice
Dec 07, 2020

Baxter SIGMA Spectrum Infusion Pumps with Master Drug Library (Versions 6 and 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software by Baxter Healthcare: Class I Recall - Due to Unplanned Shutdown Issues

Source: FDA MedWatch

Device- Warning
Sep 11, 2020

Conduct a Trial Stimulation Period Before Implanting a Spinal Cord Stimulator (SCS) - Letter to Health Care Providers

Source: FDA MedWatch

Device- Warning
Sep 11, 2020

Stop Using Gowns, including Surgical Gowns, from Laws of Motion PPE - Letter to Health Care Providers

Source: FDA MedWatch

Device- Cautionary Notice
Aug 27, 2020

Smiths Medical Recalls Medfusion 3500 and 4000 Syringe Pumps Due to Risk of Medication Delivery Error

Source: FDA MedWatch

Device- Cautionary Notice
Aug 17, 2020

CME America Updates Recall of BodyGuard Infusion Pump System Due to Risk of Over-, and Under-infusion

Source: FDA MedWatch

Device- Cautionary Notice
Jul 30, 2020

CME America Announces a Follow-Up on the Voluntary Recall of BodyGuard® Infusion System Administration Sets

Source: FDA

Drug- Warning
Jul 30, 2020

Opioid Pain Relievers or Medicines to Treat Opioid Use Disorder: MedWatch Safety Alert - FDA Recommends Health Care Professionals Discuss Naloxone with All Patients when Prescribing

Source: FDA MedWatch

Drug- Cautionary Notice
Jul 16, 2020

Mylan Initiates Voluntary Nationwide Recall of One Lot of Daptomycin for Injection, Due to The Presence of Particulate

Source: FDA MedWatch

Device- Warning
Jun 08, 2020

Johnson & Johnson’s DePuy Synthes recalls USS II Polyaxial 3D heads (11/11/2019)

Source: Industry

Device- Warning
Jun 08, 2020

NuVasive, Inc. issues Urgent Field Safety Notice to inform healthcare providers caring for patients with MAGEC System Model X rods (2/13/2020)

Source: Industry

Drug- Cautionary Notice
May 11, 2020

Fresenius Kabi's Recall of Ketorolac Results In QuVa Pharma® Recall of Compounded Sterile Product (R.E.C.K.)

Source: FDA MedWatch

Device- Cautionary Notice
Apr 23, 2020

B. Braun Medical Inc. Issues Voluntary Nationwide Recall of One (1) Lot of Ceftazidime for Injection USP and Dextrose Injection USP (50 mL), Duplex Container Due to Out-of-Specification Results for High Molecular Weight Polymers

Source: FDA MedWatch

Drug- Warning
Apr 23, 2020

Fresenius Kabi Issues Voluntary Nationwide Recall of 13 Lots of Ketorolac Tromethamine Injection, USP Due to the Presence of Particulate Matter in Reserve Samples

Source: FDA MedWatch

Device- Cautionary Notice
Apr 01, 2020

CME America Recalls BodyGuard Infusion Pump System Due to Risk of Over-, and Under-infusion

Source: FDA MedWatch

Device- Cautionary Notice
Mar 24, 2020

CME America Recalls BodyGuard Microset Infusion Sets for the BodyGuard Infusion Pump System Due to Risk of Under-Infusion

Source: FDA MedWatch

Device- Cautionary Notice
Mar 11, 2020

Becton Dickinson (BD) CareFusion 303 Inc. Recalls Alaris System Infusion Pumps Due to Software and System Errors

Source: FDA MedWatch

Drug- Warning
Mar 11, 2020

Hikma Pharmaceuticals USA Inc. Extends Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP 30mg/mL, 1mL Fill/2mL Vials Due to the Potential Presence of Small Particulates

Source: FDA MedWatch