139 results · 23ms · Sources: EU EUDAMED, US FDA

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AGI-2237 Portable 2 Cylinder Manifold Cart, for connecting medical gas cylinders.

FDA Recall
Terminated ·Airgas Puritan Medical Puritan Medical Unit·Product code CAN·August 6, 2009

AGI-2238 Portable 4 Cylinder Manifold Cart, for connecting medical gas cylinders.

FDA Recall
Terminated ·Airgas Puritan Medical Puritan Medical Unit·Product code CAN·August 6, 2009

CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with operating Software Version B1A, marketed by CDL Medical Tech.

FDA Recall
Terminated ·GVI Technology Partners·Product code IYX·January 16, 2004

PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01 Product Usage: The PRN 50M+ Paper Chart Recorder thermally records patient data on a paper strip. This device is intended for use under direct supervision of a licensed health care practitioner. This device is not intended for home use.

FDA Recall
Terminated ·Gsi Group Inc·Product code DSF·December 2, 2015

ZVU Functional GI Software, REF: ZVU-3

FDA Recall
Open, Classified ·Diversatek Healthcare·Product code FFX·July 25, 2023

Multitom RAX with software version VF10

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·April 20, 2021

PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve

FDA Recall
Terminated ·Pentax Medical Company·Product code KOG·July 17, 2014

Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721

FDA Recall
Open, Classified ·Product code PPB·January 7, 2026

Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721

FDA Recall
Open, Classified ·Product code PPB·January 7, 2026

Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.

FDA Recall
Terminated ·RGI Medical Manufacturing, Inc.·Product code FPA·March 28, 2014

Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation Manuals.

FDA Recall
Terminated ·Fujifilm Medical Systems U.S.A., Inc.·Product code FDT·June 30, 2015

Medical Gas Yoke Assembly. Airgas Portable 4-Cylinder Manifold Cart Model #AGI-2238. The device is a medical gas yoke assembly which is used to connect gas cylinder post valves to equipment used for anesthesia or respiratory therapy.

FDA Recall
Terminated ·Western a Scott Fetzer Company·Product code CAN·August 10, 2009

Medical Gas Yoke Assembly. Airgas Portable 2-Cylinder Manifold Cart Model #AGI-2237. The device is a medical gas yoke assembly which is used to connect gas cylinder post valves to equipment used for anesthesia or respiratory therapy.

FDA Recall
Terminated ·Western a Scott Fetzer Company·Product code CAN·August 10, 2009

Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm Catalog Number: 7208 Intended use: single use accessory devices used through the working channel of a GI endoscope

FDA Recall
Completed ·Shent USA, Inc.·Product code OCZ·January 12, 2021

Grasper/Retriever, Alligator Jaw, Rat Tooth 2.4 mm x 8 mm x 230 cm Catalog Number: 7226 Intended use: single use accessory devices used through the working channel of a GI endoscope

FDA Recall
Completed ·Shent USA, Inc.·Product code OCZ·January 12, 2021

Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI (gastrointestinal) endoscopic procedure.

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code ODC·May 12, 2026

Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, and ED-450XT. Medical endoscope for the duodenum and upper G.I. tract. Open elevator wire channel duodenoscopes.

FDA Recall
Terminated ·Fujifilm Medical Systems U.S.A., Inc.·Product code FDT·August 31, 2015

PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used in place of the standard Air/Water Valve to deliver a non-explosive gas for insufflation.

FDA Recall
Terminated ·Pentax Medical Company·Product code FCX·September 16, 2013

Surgidyne S-Vac round fluted channel silicone drain, 1/8" trocar, 10 FR, round, full fluted, 28 cm length, 4 channel, contains 10, sterile, Sterion Inc., Ham Lake, MN; REF 332187. The device is a sterile, portable closed system designed to evacuate post-operative wound drainage and promote healing.

FDA Recall
Terminated ·Aspen Surgical Products, Inc.·Product code GCY·April 13, 2009

19FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage

FDA Recall
Terminated ·Aspen Surgical Products, Inc.·Product code GCY·March 20, 2014