Recall Register

Terumo Medical Corporation: FDA recalls

FDA enforcement reports name Terumo Medical Corporation as the recalling firm in 8 events. The events have 19 product records. The recalls started from 2013 to 2026. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

8 events, newest first.

FDA enforcement events of Terumo Medical Corporation
InitiatedProduct (first record)TypeClassRecordsStatus
15 Jun 2026GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.DeviceClass II1Ongoing
26 Apr 2019SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, STFI-1435, STFI-1625, STFI-1635, STFI-1825, STFI-1835, STFI-1925, STFI-1935, STFI-2125, STFI-2135 Product Usage: The SoloPath Balloon Expandable TransFemoral Introducer System (STFI) and the SoloPath Re-Collapsible Access System are sterile,…DeviceClass I3Terminated
8 Feb 2019Terumo Sur-vet Needle, 20G x 1", Product Code 100204DeviceClass II9Terminated
12 Sep 2017Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal, carotid, and peripheral arteries.DeviceClass II1Terminated
16 Mar 2016PINNACLE Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM Sheath PINNACLE TIF TIP" Introducer Sheath PINNACLE R/O II Radiopaque Marker Introducer SheathDeviceClass II1Terminated
6 Nov 2015Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.DeviceClass II1Terminated
5 Aug 2015SurFlo IV CatheterDeviceClass II1Terminated
30 May 2013Pinnacle Destination Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. Acts as a conduit to facilitate the introduction of interventional and diagnostic devices into the human vasculature.DeviceClass II2Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Terumo Medical Corporation: events for each product type
TypeEvents
Device8
Terumo Medical Corporation: events in each class
ClassEvents
Class II7
Class I1
Share of the events of the firm in Class I
13%
Share of all events on the register in Class I
18%
Events with the status Ongoing
1

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Terumo Medical Corporation, by the year that the recall started. The largest year is 2015, with 2 events.

Official channels

Cite this page

Recall Register. Terumo Medical Corporation: FDA recalls. https://recallregister.com/firm/terumo-medical-corporation/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
MD

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Terumo Medical Corporation have?
Class II: 7 events. Class I: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Terumo Medical Corporation?
FDA event 99285, which the firm started on 15 Jun 2026. The first product in the record is: GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.
How many FDA recalls of Terumo Medical Corporation have the status Ongoing?
1 event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.