Equipment Recalls

Medical Device Recall - JMC5A Ni/TrueAire-5 Oxygen Concentrator, Model: O2C5L

Stryker - McGrath Mac Video Laryngoscope

Ambu-King LTS-D Recall

Nationwide Recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Vial, 20-Count Carton Due to Vial Breakage

Phillips HS 1/OnSite/Home AEDs Pad Recall

Cardinal Health Recalls Monoject Saline Flush Prefilled Syringes for Risk of Air Re-entering Syringe Leading to Air Embolism

Pulse Oximeter Accuracy and Limitations: FDA Safety Communication

Mylan Initiates Voluntary Nationwide Recall of Four Lots of Amiodarone HCl Injection, USP and Tranexamic Acid Injection, USP Due to Carton Label Mix-Up

GlideScope Core One TouchSmart Cable (“OneTouch cable”) by Verathon: Class I Recall - Due to Partial or Complete Loss of Image During Use

ITECH 361 Issues Voluntary Nationwide Recall of All Clean Hand Sanitizer and Moisturizer and Disinfectant Due to The Potential Presence of Undeclared

Methanol (Wood Alcohol)

FDA MedWatch - Epinephrine Auto-Injector Devices by Amneal and Impax: CDER Alert

Stryker - Infant Child Reduced Energy Electrodes for Physio-Control LIFEPAK® Defibrillators

Certain Filtering Facepiece Respirators from China May Not Provide Adequate Respiratory Protection - Letter to Health Care Providers

Stryker LIFEPAK 500 Recall

Fresenius Kabi Issues Voluntary Nationwide Recall of 13 Lots of Ketorolac Tromethamine Injection

EpiPen Auto-Injector Recall

Tytek Medical Recalls TM-317 PneumoDart-Pneumothorax Needle Due to Fully and Partially Blocked Needles

King Systems Issues Recall of King Vision Video Laryngoscope Video Adapter Size 1/2

Stryker - LIFEPAK 15 Monitor/Defibrillator

Physio-Control Recalls LIFEPAK15 Monitor/Defibrillator Due to Risk of Device "Lockup" (Freezing)

Drug Shortages Extended Use Dates Provided by Pfizer

Phillips Healthcare recalls HeartStart MRx Monitor/Defibrillator due to electrical issues that may prevent the device from operating properly.

Physio-Control Inc. Recalls LIFEPAK 1000 Defibrillator Due to an Electrical Issue Which May Cause the Device to Shut Down Unexpectedly

MAD Recall 

MAD Recall Lot Number Example

Leonhard Lang Multi-function Defibrillation Electrodes DF29N Will Not Work with Welch Allyn Automatic External Defibrillator model AED 10

Hospira Issues A Voluntary Recall For One Lot Of 50% Magnesium Sulfate Injection, USP Due To The Presence Of Particulate

Sodium Bicarbonate Injection, USP by Hospira: Recall - Particulate Matter

GlideScope Titanium Single-Use Video Laryngoscope by Verathon: Class I Recall - Potential Video Feed Disruption

Baxter Issues Voluntary Nationwide Recall of One Lot of 0.9% Sodium Chloride Solution for Irrigation Due to Presence of Particulate Matter

Baxter initiates Voluntary Nationwide Recall of Select Lots of IV Solutions Due to the Potential for Leaking Containers and Particulate Matter

Magnesium Sulfate in Water for Injection by Hospira: Recall - Incorrect Barcode Labeling on the Primary Container

Baxter Initiates Voluntary Recall of Two Lots of IV Solutions due to Potential Presence of Particulate Matter

Auvi-Q (epinephrine injection, USP): Recall - Potential Inaccurate Dosage Delivery

Western/Scott Fetzer Company OxyTOTE Portable Oxygen Unit May Ignite and Burst

Teleflex Hudson RCI Lifesaver Single Patient Use Manual Resuscitator Intake Port Blockage

Intravenous (IV) Solutions (Select Lots) by Baxter: Recall - Potential Presence of Particulate Matter

Hospira Issues a Voluntary Nationwide Recall of One Lot of Lactated Ringer's Irrigation Due to Mold Contamination

Hospira Issues a Voluntary Nationwide Recall of One Lot of 0.9% Sodium Chloride Injection, USP, 250 mL VisIV™ Container Due to Particulate Matter

Ketorolac Tromethamine Injection by Hospira: Recall - Particulate in Glass Vials

0.9 Percent Sodium Chloride Injection, USP, 250 mL by Hospira : Recall - Particulate Matter

CONMED PadPro and R2 Multi-function Defibrillation Electrodes: Device Correction - Connector Compatibility Issue With Philips FR3 and FRx Defibrillator Units

Hospira Announces Voluntary Nationwide Recall Of One Lot Of 1% Lidocaine HCI Injection, USP 10 MG Per ML, 30 ML Single-Dose. Preservative-Free, Due To

Particulate Matter

Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of Three Lots of Ketorolac Tromethamine Injection, USP, 30mg/ml Due to Labeling the Product

with the Incorrect Expiration Date

Baxter Initiates Voluntary Recall of One Lot of 0.9% Sodium Chloride Injection, USP Intravenous (IV) Solution

Lidocaine HCI Injection, USP, 2 percent, by Hospira: Recall - Visible Particulates

Hospira Lactated Ringer's And 5% Dextrose Injection, 1000 ML, Flexible Containers: Recall (One Lot) - Mold Contamination

Dobutamine Injection (250mg/20mL)/Hospira: Recall - Visible Particulates 

Lidocaine HCI Injection, USP, by Hospira: Recall - Visible Particulates

Abbott Diabetes Care, Inc. FreeStyle and FreeStyle Flash Blood Glucose Meters including the FreeStyle Blood Glucose Meter built into the OmniPod Personal

Diabetes Manager (PDM) - Erroneously Low Blood Glucose Results

Teleflex Medical, ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port (with and without Preloaded Stylet) - Potential Kinking During Patient Use

Etomidate Injection/Pfizer-Mylan: Recall

Lidocaine HCI Injection and Diltiazem Hydrochloride Injection Recall

Baxter Initiates Worldwide Voluntary Recall Of Select Lots Of 5 percent Dextrose Injection, USP And 0.9 percent Sodium Chloride Injection, USP Intravenous (IV) Solutions

Lidocaine HCl Injection 2%, 5 ml Vial by Hospira: Recall - Presence of Particulate Matter

Abrams Royal Pharmacy Sterile Products - Recall - Lack of Sterility Assurance

HeartStart Automated External Defibrillators (AED) From Philips Healthcare: Safety Communication - Failure Of An Electrical Component That Could Cause

AEDs To Fail To Deliver Appropriate Shock

Ford Recalls Ambulances

Albuterol Sulfate Inhalation Solution, 0.083 percent (Nephron Pharmaceuticals): Recall - Aseptic Processing Simulation Results

Verathon, Inc., GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and 5 Reusable Blade

Abbott Initiates Voluntary Recall of FreeStyle lnsulinx® Blood Glucose Meters in the United States

Sodium Chloride Injection, 0.9 percent, 1000 mL, Flexible Container: Recall - Brass Particulates

Verathon Inc. Issues Voluntary Recall of Certain GlideScope GVL Video Laryngoscope Reusable Blades

American Regent Recalls Epinephrine Lot 1395

Morphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject by Hospira, Inc: Recall - May Contain More Than Intended Fill Volume

Various Automated External Defibrillators (AEDs) Recalls

Oridion's End Tidal CO2 Disposable Filterlines Recalled - Letter From Philips Healthcare

Defibtech Voluntary Recall DDU-100 Series AEDs

Bacteriostatic Sodium Chloride Injection, USP, 0.9% 30 mL Multiple Dose Vials

Amiodarone Recall Letter                     Amiodarone Recall Notification

Triad Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks: Recall Due to Potential Microbial Contamination

Albuterol Sulfate Inhalation Solution 0.083%, 3 mL Unit Dose Vials: Recall - Mislabeled Unit Dose Vials

American Regent Initiates Nationwide Voluntary Recall of Sodium Bicarbonate Injection, USP 7.5% and 8.4%, 50mL Single Dose Vials Due to Particulate Matter 

Abbott Glucose Test Strips: Recall - False Low Blood Glucose Results

Westmed Inc., BagEasy Manual Resuscitation Devices

Westmed, Inc. Issues Nationwide Recall of BagEasy Manual Resuscitation Devices

List of FDA Device Recalls 2010

Defibtech Announces a Voluntary Recall of DBP-2800 Battery Packs used in the Lifeline AED^® and ReviveR AED^TM

ZOLL E Series Defibrillator/Pacemaker/Monitors

Philips—CPR Meters Used with HeartStart MRx Monitors/Defibrillators

Physio-Control Inc., LIFEPAK 15 Monitor/Defibrillator

Cardiac Science Notifies AED Customers of Voluntary Medical Device Recall

Covidien Pedi-Cap End-Tidal CO2 Detector

Physio-Control Inc., LIFEPAK CR Plus AEDs Recall Class: Class I Date Recall

Philips Issues Worldwide Recall of Select Heartstart Fr2+ AED's

Cardiac Science Notifies AED Customers of Nationwide Voluntary Medical Device Correction

LifeScan, Inc. is conducting a voluntary recall of eight lots of OneTouch® SureStep® Test Strips