The Recall Desk

Manufacturer

Terumo Medical Corporation

19 recalls in our database name Terumo Medical Corporation as the manufacturing or recalling firm.

What the numbers show

Total
19
Critical
0
Severe
1
Most recent
2026-08-19

Of the 19 recalls from Terumo Medical Corporation we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (5%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–19 of 19

  • ModerateFDA (Devices)·Z-2930-2026·2026-08-19

    Terumo Glidesheath Slender A-Kit Recalled for Incorrect Guidewire Packaging

    Terumo Medical Corporation is recalling 7,490 units of Glidesheath Slender A-Kits because they were packaged with a 0.025 guidewire instead of the specified 0.021 guidewire.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2004-2019·2019-07-31

    Terumo 18G Needles Recalled for Potential Loss of Package Integrity

    Terumo Medical Corporation is recalling 810,000 18G needles due to a potential loss of package integrity that may compromise sterility.

    Product
    Terumo Needle, 18G x 1", Product Code NN1825R
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2005-2019·2019-07-31

    Terumo Medical Recalls 23G Needles Due to Potential Sterility Compromise

    Terumo Medical Corporation is recalling 30,000 units of 23G x 1-inch needles (Lot 180811C) because a potential loss of package integrity may compromise the product's sterility.

    Product
    Terumo Needle, 23G x 1", Product Code NN2325R
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-1999-2019·2019-07-31

    Terumo Sur-vet Needle Recall Due to Potential Loss of Package Integrity

    Terumo Medical Corporation is recalling 444,000 Sur-vet Needles because a potential loss of package integrity may compromise the sterility of the product.

    Product
    Terumo Sur-vet Needle, 22G x 1", Product Code 100211
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2002-2019·2019-07-31

    Terumo Sur-vet Needle Recall Due to Potential Loss of Package Integrity

    Terumo Medical Corporation is recalling 844,000 Sur-vet Needles because a loss of package integrity may compromise the sterility of the product.

    Product
    Terumo Sur-vet Needle, 22G x 3/4", Product Code 100279
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2003-2019·2019-07-31

    Terumo Sur-vet Needle Recall Due to Potential Loss of Package Integrity

    Terumo Medical Corporation is recalling 563,000 Sur-vet Needles because a potential loss of package integrity may compromise the sterility of the product.

    Product
    Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-2006-2019·2019-07-31

    Terumo 30G Needle Recall Due to Potential Sterility Compromise

    Terumo Medical Corporation is recalling 81,000 30G needles due to a potential loss of package integrity that may compromise sterility.

    Product
    Terumo Needle, 30G x 1/2", Product Code NN3013R
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-1998-2019·2019-07-31

    Terumo Sur-vet Needle Recall Due to Potential Loss of Package Integrity

    Terumo Medical Corporation is recalling 729,000 Sur-vet Needles because a potential loss of package integrity may compromise the sterility of the product.

    Product
    Terumo Sur-vet Needle, 20G x 1", Product Code 100204
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-2000-2019·2019-07-31

    Terumo Sur-vet Needle Recall Due to Potential Sterility Compromise

    Terumo Medical Corporation is recalling 638,000 Sur-vet Needles due to a potential loss of package integrity that may compromise sterility.

    Product
    Terumo Sur-vet Needle, 22G x 3/4", Product Code 100215
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-2001-2019·2019-07-31

    Terumo Sur-vet Needle Recall Due to Potential Loss of Package Integrity

    Terumo Medical Corporation is recalling 440,000 Sur-vet Needles due to a potential loss of package integrity that may compromise sterility.

    Product
    Terumo Sur-vet Needle, 25G x 5/8", Product Code 100220
    Category
    Medical Device
    Distribution
    12 states
  • SevereFDA (Devices)·Z-1376-2019·2019-06-05

    Terumo Portico Solo Re-Collapsible Access System Recalled for Tip Dislodgement

    Terumo Medical Corporation is recalling Portico Solo Re-Collapsible Access Systems because the tip may dislodge from the sheath, potentially causing injury.

    Product
    Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1374-2019·2019-06-05

    Terumo Recalls SoloPath Balloon Expandable TransFemoral Systems Due to Tip Dislodgement Risk

    Terumo Medical Corporation is recalling 2,228 SoloPath Balloon Expandable TransFemoral Systems because the device tip may dislodge from the sheath, potentially causing vessel trauma.

    Product
    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 SoloPath Balloon Expandable TransFemoral Introducer System (STFI) a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1375-2019·2019-06-05

    Terumo SOLOPATH Re-Collapsible Access System Recalled for Tip Dislodgement Risk

    Terumo Medical Corporation is recalling 1,431 SOLOPATH Re-Collapsible Access Systems because the tip may dislodge from the sheath, potentially compromising the device's smooth transition.

    Product
    SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, SR-2425, SR-2435
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0725-2018·2018-03-07

    Terumo Destination Guiding Sheath Recalled for Specification Deviation

    Terumo Medical Corporation is recalling 33 units of Destination Guiding Sheath catheter introducers because the tucking depth feature is marginally outside the upper specification.

    Product
    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 vasculature, including but not limited to the renal, caroti
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2033-2017·2017-05-10

    Terumo Destination Renal Guiding Sheath Recalled for Missing Coating

    Terumo Medical Corporation is recalling Destination Renal Guiding Sheaths because the distal end may lack the labeled 5 cm of coating, potentially making device navigation difficult.

    Product
    Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2738-2016·2016-09-14

    Terumo Recalls Pinnacle Introducer Sheaths Due to Valve Leakage

    Terumo Medical Corporation is recalling Pinnacle Introducer Sheaths due to a manufacturing issue causing valve leakage, which poses a risk of incremental blood loss.

    Product
    PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer Sheath PINNACLE¿ R/O II Radiopaque Marker Introducer Sheath
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1612-2013·2013-07-03

    Terumo Glidesheath Recalled for Incorrect Expiration Date Labeling

    Terumo Medical Corporation is recalling 550 units of Glidesheath products due to incorrect expiration date labeling.

    Product
    Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060. Used to facilitate placing a catheter through the skin into a vein or artery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1611-2013·2013-07-03

    Terumo Pinnacle Destination Peripheral Guiding Sheath Recalled for Labeling Error

    Terumo Medical Corporation is recalling 20 units of Pinnacle Destination Peripheral Guiding Sheaths because they were incorrectly labeled with extended expiration dates.

    Product
    Pinnacle¿ 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Terumo Medical (United States)

company in Somerset, United States

Country
United States
Founded
1921
Parent company
Terumo (United States)

Official website

Source: Wikidata (Q30298270), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.