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Sources: EU EUDAMED, US FDA
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Flat Proximal Pressurizer. Bone cement pressurizers are intended to help seal the delivery path between the delivery nozzle and bone in order to pressurize the cement during delivery.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code KIH·January 13, 2012
Orthovita(R) Cortoss(TM) Delivery Gun Product Usage: Used for the application of Cortoss(TM) Bone Augmentation Material
FDA Recall
Terminated
·Orthovita, Inc.·Product code KIH·March 31, 2011
Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation to be used during surgical procedures utilizing the Small Diameter Cement Plug implant devices Item Number: 414989
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code KIH·February 28, 2019
The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet is used to deliver bone cement from the Optivac.
FDA Recall
Terminated
·BIOMET FRANCE S.A.R.L. plateau de lautagne valence cedex·Product code KIH·May 14, 2015
Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone
FDA Recall
Terminated
·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code KIH·August 20, 2015
UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a Tyvek pouch. The secondary package is a corrugate box. 5 units per box. Used to cover the opening to the biopsy/suction channel of an endoscope.
FDA Recall
Terminated
·US Endoscopy Group Inc·Product code KOG·October 31, 2014
Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable Velocity biopsy valve is used to cover the opening of the biopsy inlet port of a flexible gastrointestinal endoscope. The Velocity biopsy valve provides access for endoscopic device passage and exchange, helps maintain insufflation, and minimizes leakage of biomaterial from the accessory port throughout the gastrointestinal endoscopic procedure. The Velocity biopsy valve provides a connection for irrigation through the Velocity irrigation pump.
FDA Recall
Terminated
·US Endoscopy Group Inc·Product code OCX·February 17, 2015
MX20170: Pediatric 40 In Sampling Kit w/10cc syringe, MX20443: LogiCal Single Pressure Kit, MX20470: Pressure Monitoring Kit, MX20477: LogiCal Double Kit, MX20730: Double LogiCal Kit, MX20760: Neonatal 18'' Add-On Kit, MX20822: TranStar Monitoring Set, MX4033: Kids Kit 18in (45.7cm) Add-on Blood Sampling Kit, MX4037: Kids Kit Add-On Blood Sampling Kit, MX700376: TranStar Triple Monitoring Kit, MX700377: Double TranStar Kit, MX7781R1: St Judes Secure Kit, MX8004CSTT: Novatrans Mtring Kit 60 (152.4cm) Single Line, MX8033T: Novatrans Kids Kit Neonatal Mtring, MX9502CSTT: TranStar 72in (183cm) Secure Double Kit, MX9504CSTT: TranStar 60in (152cm) Secure Monitoring Kit, MX9505CSTT: TranStar 84in (213) Secure Monitoring Kit, MX9506CSTT: TranStar 72in Secure Triple Kit, MX9533T: TranStar Kids Kit Neonatal Monitoring Kit, MX9534T: TranStar Kids Kit, MX9537T: TranStar Kids Kit, MX9602CSTA: LogiCal 72in (183cm) Secure Double Kit, MX9604CSTA: LogiCal 60in (152cm) Secure Monitoring Kit, MX9605CSTA: LogiCal 84in (213cm) Secure Monitoring Kit, MX9606CSTA: LogiCal 72in (183cm) Secure Monitoring Kit, MX9607CSTA: LogiCal Triple Secure Kit, MX9634A: LogiCal Kids Kit Neonatal Monitoring Kit, MX9637A: LogiCal Kids Kit Neonatal Monitoring Kit, SX02: Sterile Sample
FDA Recall
Terminated
·Medex Inc·Product code DQO·October 20, 2004
UP & UP kids' power toothbrush
FDA Recall
Terminated
·Ranir Corporation·Product code JEQ·December 18, 2013
Rocket KCH Fetal Bladder Drainage Catheter Model: R57405
FDA Recall
Terminated
·Rocket Medical Plc Industrial Estate Sedling Road Wear Indu Tyne & Wear Washington United Kingdom·Product code MPR·August 1, 2019
TopCare Clifford THE BIG RED DOG power toothbrush for kids!
FDA Recall
Terminated
·Ranir Corporation·Product code JEQ·December 18, 2013
Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for Kids is a mouthguard in 3 different sizes (sm, med, lg) that can be used in children ages 3-15 to address breathing and myofunctional disorders. Catalog Numbers:
FDA Recall
Open, Classified
·Myofunctional Research Company USA·Product code LRK·October 9, 2025
Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)
FDA Recall
Completed
·Basic Reset Inc.·Product code N/A·October 18, 2019
Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005
FDA Recall
Open, Classified
·Product code KKX·January 7, 2026
Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005
FDA Recall
Open, Classified
·Product code KKX·January 7, 2026
Smiths Medical, Add-On Kids Kit , Blood Sampling System, Product Code: MX4037, Smiths Medical ASD, Inc, Dublin, Ohio 43016
FDA Recall
Terminated
·Smiths Medical Asd Inc·Product code CBT·November 21, 2007
Smiths Medical, Add-On Kids Kit , Blood Sampling System, Product Code: MX4033, Smiths Medical ASD, Inc, Dublin, Ohio 43016
FDA Recall
Terminated
·Smiths Medical Asd Inc·Product code CBT·November 21, 2007
medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9544
FDA Recall
Open, Classified
·Smiths Medical ASD, Inc.·Product code DPT·September 24, 2024
medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548
FDA Recall
Open, Classified
·Smiths Medical ASD, Inc.·Product code DPT·September 24, 2024
medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547
FDA Recall
Open, Classified
·Smiths Medical ASD, Inc.·Product code DPT·September 24, 2024