Elkton, MD, United States
Terumo Medical Corporation recalls
5 recalls recorded since 2018, most recently on 15 June 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)1
Terminated or completed4
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 15 June 2026
- Reason
- Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2930-2026
- 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.
Terminated Class I Medical devices
- Recall started
- 26 April 2019
- Terminated
- 22 September 2020
- Reason
- There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.
- Distribution
- The products were distributed US nationwide. The products were distributed to the following foreign countries: Australia, Belgium, Brazil, Canada, Portugal, Hong Kong, Peru, Singapore.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1374-2019, Z-1376-2019, Z-1375-2019
- SOLOPATH 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 SoloPat
- Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20
- SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, SR-2425, SR-2435
Terminated Class II Medical devices
- Recall started
- 8 February 2019
- Terminated
- 8 May 2020
- Reason
- There is a potential for a loss of package integrity that may compromise the sterility of the product.
- Distribution
- The products were distributed to the following US states: FL, IN, KS, KY, MA, MO, NH, NV, PA, SC, TN, and TX.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2003-2019, Z-2005-2019, Z-1998-2019, Z-1999-2019, Z-2000-2019, Z-2004-2019, Z-2006-2019, Z-2002-2019, Z-2001-2019
- Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280
- Terumo Needle, 23G x 1", Product Code NN2325R
- Terumo Sur-vet Needle, 20G x 1", Product Code 100204
- Terumo Sur-vet Needle, 22G x 1", Product Code 100211
- Terumo Sur-vet Needle, 22G x 3/4", Product Code 100215
- Terumo Needle, 18G x 1", Product Code NN1825R
- Terumo Needle, 30G x 1/2", Product Code NN3013R
- Terumo Sur-vet Needle, 22G x 3/4", Product Code 100279
- and 1 more product lines
Terminated Class II Medical devices
- Recall started
- 9 April 2018
- Terminated
- 19 April 2019
- Reason
- Two lots of product were released for distribution prior to the completion of all required validation and lot acceptance activities. Although sterile, products from these lots may not function as intended and therefore should not be used.
- Distribution
- Distributed to accounts in AL, CA, FL, IA, IN, MI, MO, NC, NY, SD, TN, and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2337-2018
- Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135
Terminated Class II Medical devices
- Recall started
- 12 September 2017
- Terminated
- 31 August 2018
- Reason
- The tucking depth feature of this catheter introducer is marginally outside the upper specification.
- Distribution
- To be added.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0725-2018
- Destination 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.