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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2) KCFW-9.0-18/38-45-RB-ANL1-HC; 3) KCFW-10.0-35-45-RB-HFANL0-HC; 4) KCFW-10.0-35-45-RB-HFANL1-HC; 5) KCFW-12.0-35-45-RB-HFANL0-HC; 6) KCFW-12.0-35-45-RB-HFANL1-HC; 7) KCFW-9.0-35-38.5-RB-RTPS-100; 8) KCFW-10.0-35-RB-RTPS-100; 9) KCFW-9.0-38-55-RB-RAABE; 10) KCFW-9.0-38-70-RB-RAABE; 11) KCFW-9.0-38-80-RB; 12) KCFW-10.0-38-30-RB; 13) KCFW-10.0-38-40-RB; 14) KCFW-10.0-38-80-RB; 15) KCFW-10.0-38-RB; 16) KCFW-12.0-38-40-RB; 17) KCFW-12.0-38-80-RB; Flexor Introducers and Guiding Sheaths are designed to perform as a guiding sheath and/or introducer sheath. Flexor Introducers and Guiding Sheaths incorporate a Flexor shaft with a hemostasis valve and are provided with one or more dilators. These devices are available in various sizes, lengths and configurations. Configurations include differences in shaft construction, such as varying shaft stiffness and distal tip material and shape, dilator material, hydrophilic coating and/or distal radiopaque markers.
FDA Recall
Open, Classified
·Cook Incorporated·Product code DYB·November 26, 2025
Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023070S
FDA Recall
Open, Classified
·Sarnova HC, Llc·Product code LNZ·February 12, 2024
Curaplex Field Cric Kit with ET Tube, Item Number 36611. The kit provides healthcare professionals with an assortment of supplies to perform a cricothyrotomy.
FDA Recall
Open, Classified
·Sarnova HC, Llc·Product code CAE·November 6, 2023
Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm, Item Number 351631i-A. The kit provides healthcare professionals with an assortment of supplies to perform a cricothyrotomy.
FDA Recall
Open, Classified
·Sarnova HC, Llc·Product code CAE·November 6, 2023
Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023060S
FDA Recall
Open, Classified
·Sarnova HC, Llc·Product code LNZ·February 12, 2024
Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/o Hanger Bar, REF: 55300H-NA, patient lifts
FDA Recall
Open, Classified
·Human Care Hc Sweden Ab Arstaangsvagen 21 B Stockholm Sweden·Product code FSA·February 23, 2024
DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic procedures.
FDA Recall
Open, Classified
·Aesculap Inc·Product code GCJ·January 9, 2024
HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle only, with Cojoined Suction and Irrigation Tubing, Catalog number 0026880
FDA Recall
Open, Classified
·Davol, Inc.·Product code GCJ·June 7, 2022
VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS
FDA Recall
Open, Classified
·Product code GCJ·March 22, 2023
VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS
FDA Recall
Open, Classified
·Product code GCJ·March 22, 2023
Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number S101010
FDA Recall
Open, Classified
·Product code GCJ·March 1, 2023
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 35 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7044; endoscopic surgical device
FDA Recall
Open, Classified
·Carefusion 2200 Inc
75 N Fairway Dr
Vernon Hills IL 60061-1845·Product code GCJ·July 13, 2023
YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR
FDA Recall
Open, Classified
·Surgical Innovations Ltd 6 Clayton Wood Bank Lds Leeds United Kingdom·Product code GCJ·March 28, 2023
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL
FDA Recall
Open, Classified
·Product code GCJ·February 28, 2024
Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip
FDA Recall
Open, Classified
·Stryker Corporation·Product code GCJ·June 18, 2025
Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
FDA Recall
Open, Classified
·Canadian Hospital Specialties Ltd.·Product code GCJ·June 11, 2024
Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
FDA Recall
Open, Classified
·Capnia Inc·Product code CCJ·April 21, 2025
Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and sterilized for single use only. The bag may be used for multiple specimen retraction.
FDA Recall
Open, Classified
·Genicon, Inc.·Product code GCJ·June 27, 2018
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT
FDA Recall
Open, Classified
·Product code GCJ·February 28, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL
FDA Recall
Open, Classified
·Product code GCJ·February 28, 2024