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Alert Archives



Ultradent Products Inc., issued an alert for various absorbent points- Due to the barcode label being placed under the sterile barrier and product being re-wrapped (11/17)

Zimmer Biomet (Various Dental Products) - Due to several parts being shipped with only Standard IFU/Missing Supplemental IFU (11/17)

Zimmer Biomet issued an URGENT Medical Device Recall: Due to Device Not Engaging Properly with Mating Components (11/17)

Physio-Control Inc issued an urgent Medical Device Recall: Due to artwork depicts incorrect electrode placement for infants (11/17)

CPAC Equipment, Inc., Cox RapidHeat Sterilizers' (Models 6000 & 6220) Battery Program May Cause Power Failure (PF) Errors (10/17)

CPAC Equipment, Inc., Cox RapidHeat Sterilizers' (Models 6000 & 6220) Printer Attachment May Cause Cycles to Fail (10/17)

GloxoSmithKline issued a Recall on Parodontax Whitening Daily Fluoride & Antigingivits Toothpaste: Due to Possibility of the Presence of Metal in Product (10/17)

Xttrium Laboratories, Inc. issued a Recall on Chlorhexidine 0.12% Oral Rinse: Due to Contaminants on Exterior Packaging (10/17)

SAGE® Products, Inc. Issued a Worldwide Recall on Various Oral Care Products: Due to Cross-Contamination (10/17)

ZIMMER BIOMET issued an Urgent Medical Device Corrections for Various Dental products Due to Missing Supplemental IFUs (9/17)

3M™ Comply™ Steam Indicator Tapes (Catalog #1322 & #1355): Ink May Fade After Sterilization (9/17)

Broselow Bag Resuscitation Devices: Bag-Valve-Mask Assemblies for Pediatric & Infant Resuscitation RECALL UPDATE (8/17)

3M Canada Peridex Oral Rinse (0.12% w/v Chlorhexidine Gluconate RECALL (7/17)

Aesculap Diamond Surgical Burs: Hi-Line XS Coarse/Extra Coarse Diamond Burrs RECALL (7/17)

Broselow Bag Resuscitation Devices:  Bag-Valve-Mask assemblies for Pediatric and Infant Resuscitation RECALL (5/17)

Prevident 5000 Dry Mouth formula RECALL (4/17)

LIFEPAK 15 Monitor/Defibrillators RECALL (2/17) 

Ongoing Bard Parker Conventional Stainless Steel Surgical Blade #12B Alert (2/17)

Improper Use of disinfectants with Nomad Pro/Pro 2 Handheld X-Ray System Alert (1/17)

Ivoclar Vivadent Virtual XD PVS Impression Material RECALL (12/16)

Bard Parker Conventional Stainless Steel Surgical Blade #12B (10/16)

Biomet 3i OSSEOTITE Certain Implant RECALL  (9/16)

AMSCO C and AMSCO400 Steam Sterilizers / Steris Corp/ Urgent Field Correction (4/15)

3M ESPE Clinpro 5000(1.1% Sodium Fluoride), Anti-Cavity Toothpaste, 4 oz. RECALL (3/15)

Gemlock Long HexDriver / Zimmer Dental, Inc. /RECALL (2/15)

Bone GraftSubstitutes Containing Recombinant Proteins or Synthetic Peptides in Patients underAge 18: FDA Safety Communication (1/15)

Straumann Drill Sets/Stops Used w/ 4.8 mm Diameter Implants Model 040.447S) Field Safety Notice  (12/14)

3M RelyX Temp E NP Temporary Dental Cement RECALL (12/14)

Synthes Mandible External Fixator / Synthes, Inc. RECALL (11/14)

Cancellous and Cortical Bone Grafts RECALL (11/14)

eXpert DC Intraoral Dental X-Ray System RECALL (11/14)

2Bx Filtek Supreme Ultra Flow Syringes Ugrent Corrective Action (10/14)  

Kodak INSIGHT and Ultra-Speed Dental Film RECALL (9/14)

GLUMA Desensitizer PowerGel URGENT SAFETY INFO Update (9/14)

Hemo-Stat Solution Recall (8/14)

Titan T 5K Handpiece Motors Recall (8/14)

Philips Intellivue Monitors w/ Covidien Nellcor OxiMax SpO2 Tech. Recall (8/14)  

LED Headlight System Battery Charger accessory Recall (8/14)

Lidocaine HCI Injection, USP, 2%, Recall (8/14)

Sani-Cloth Plus Germicidal Disposable Cloth Recall (8/14)  

Bluephase Style Pin-Point Light Probes RECALL (7/14)

Tytin Regular Set Double Spill Amalgam Capsules RECALL (7/14)  

Lactated Ringers And 5% Dextrose Injection (7/14)

LIFEPAK 1000 Defibrillators. Device Notice & Correction (6/14)  

0.9% Sodium Chloride Irrigation Recall (6/14)

Dental Touchsteam Portable Steamer Recall (3/14)

Ansell Sandel Weighted Safety Scalpel Recall Update (2/14)  

Propaq LT Monitors Recall (2/14)

Lidocaine Hyrdochloride Injection Recall (1/14)

Ansell Sandel Weighted Safety Scalpel (12/13)

Gauze Sponge Recall (12/13)

Gauze Report (12/13)  

Thymo-cide Recall (9/13)

Biomet Dental Implants Recall (11/13)

Verify Dual species Self-Contained Biological Indicator Recall (11/13)

Biotene Moisturizing Mouthspray Recall (11/13)

CaviWipes-160 wipes per canister Recall (11/13)

0.5% Bupivacaine HCL and Epinephrine Recall (11/13)

Recall of One Lot of 0.25% Marcaine (10/13)

Stryker Recall (9/13)

Osseotite 2 Certain Prevail/Osseotite/Biomet 3i Recall (9/13)

Recall of One Lot of 0.25% Bupivacaine HCL Injection (9/13)

Class 2 Recall; Biomet 3i T3 Dental Implant (9/13)

Getinge 46-Series Washer Disinfectors/Getinge (8/13)

LIFEPAK 500 AED/ Physio-Control Recall (8/13)

CORE and RemB Universal Drivers Stryker Recall (7/13)

Sonopet Consoles Stryker Recall (7/13)

Sybron Endo Lightspeed LSX File RECALL (3/13)

Accutron, Inc. Ultra PC Cabinet Mount Flowmeters Recall (11/12)

Bluephase (G2) and Bluephase 20i Dental Curing Light Recall (11/12)

Important Information Regarding Your Bluephase Curing Lights (11/12)

Lactated Ringer's and 5% Dextrose Injection Recall (10/12)

New England Compounding Center Product Recall (10/12)

Hospira Propofol Injectable Emulsion Recall Glass Vial Defect (9/12)

Sterrad Cyclesure 24 Biological Indicator Recall (7/12)

Spinbrush Rechargeable SONIC Toothbrush Recall (5/12)

Epinephrine Injection 1:1000 ampules recall (5/12)

Hand-held Dental X-ray Units (4/12)

Look Alike Anesthetic Cartridges (2/12)

H&P Industries Recalls Povidone Iodine Products (9/11)

Alert for Prehma 27 Gauge Long Single-Use Dental Needle (4/11)

Biomet3i™ Implant Recall (4/11)

FDA Reminder: Safe Use of Non-Sterile Alcohol Prep Pads (3/11)

Denture Adhesives Containing Zinc (3/11)

FDA Notice on Patient Burns from Electric Handpieces (12/07) UPDATED (9/10)

Titan 3™ 5K Low-Speed Motor Recall (10/10)

Sealapex Xpress Recall (8/10)

Formo Cresol Recall (2/10)

ETHICON Suture Recall (2/09)

ETHICON Bone Wax Recall (11/08)

Reported Problem with Miltex 12B Blades (11/08)

Denture Cleanser Allergic Reactions and Misuse (2/08)

Potential Problem with Air Techniques ScanX® Phosphor Storage Plates (PSP) (2/08)

QUATTROcare Air Purge Cycle (12/07)

Henry Schein Inc. 27 Gauge Needle Covers (Sheaths) More Prone to Puncture (1/07)

KaVo Recall/Replacement Program for QUATTROcare Spray Cans (12/06) UPDATED (6/07)

FDA "Permanent Injunction" Barring C. R. Canfield Co, Inc. Products (10/06) UPDATED (1/07)

NeutraGard Neutral Sodium Fluoride Rinse Recall (5/06)

Allograft Tissue Recall (12/05)

Intraoral X-Ray Machine Mountings (10/05)

Dye Leaching from Resilon-Based Obturation Materials (9/05)

Backward Cassette Placement with Panoramic X-Ray Machines (12/04)

Expired/Discolored Developer and Fixer Solutions (6/04)

Instrumentarium Imaging Announces Panoramic Radiography Modifications (3/04)

Reported Problem with Wex-Cide Products (11/03) UPDATE (5/08)

Nationwide Alert on Injectable Drugs Prepared by Urgent Care Pharmacy (11/02)

Medical Alert Posted for Orthopantomograph OP100 UPDATED (1/04)

Overheating of KaVo Surgical Handpieces (12/07)
Reported Problem with Valiant PhD (11/02)

Patient Mishap Involving a Metal Three-Way Syringe Tip (11/02)

Reconditioning of Ormco Wire Cutters (11/00)

Proper Disposal of LD Disinfectant and Exspor Disinfectant-Sterilant (Alcide Corp) (8/00)

Proper Cleaning of Insert Tips for the Cavitron Ultrasonic Scaler (1/02)

Bolting A-dec Dental Chairs to the Floor (1/02)

Proper Handling of Mercury-Contaminated Triturators (2/01)