Terumo Medical recalls
Terumo Medical appears in 39 official U.S. recall notices indexed by RecallRadar, most recently on 2026-08-19.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 39 |
|---|---|
| Published | 2013-07-03 to 2026-08-19 |
| By agency | FDA Device (39) |
| By classification | Class II (36), Class I (3) |
| By status | terminated (38), ongoing (1) |
| Distribution named in notices | AL, CA, FL, IA, IN, KS, KY, MA, MI, MO, NC, NH, NV, NY, PA, SC, SD, TN, TX, US |
Recalls
- GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box
FDA Device · Class II · 2026-08-19 · Terumo Medical
Reason: Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire. - Terumo Needle, 30G x 1/2", Product Code NN3013R
FDA Device · Class II · 2019-07-31 · Terumo Medical
Reason: There is a potential for a loss of package integrity that may compromise the sterility of the product. - Terumo Sur-vet Needle, 22G x 3/4", Product Code 100279
FDA Device · Class II · 2019-07-31 · Terumo Medical
Reason: There is a potential for a loss of package integrity that may compromise the sterility of the product. - Terumo Sur-vet Needle, 25G x 5/8", Product Code 100220
FDA Device · Class II · 2019-07-31 · Terumo Medical
Reason: There is a potential for a loss of package integrity that may compromise the sterility of the product. - Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280
FDA Device · Class II · 2019-07-31 · Terumo Medical
Reason: There is a potential for a loss of package integrity that may compromise the sterility of the product. - Terumo Sur-vet Needle, 20G x 1", Product Code 100204
FDA Device · Class II · 2019-07-31 · Terumo Medical
Reason: There is a potential for a loss of package integrity that may compromise the sterility of the product. - Terumo Sur-vet Needle, 22G x 1", Product Code 100211
FDA Device · Class II · 2019-07-31 · Terumo Medical
Reason: There is a potential for a loss of package integrity that may compromise the sterility of the product. - Terumo Needle, 18G x 1", Product Code NN1825R
FDA Device · Class II · 2019-07-31 · Terumo Medical
Reason: There is a potential for a loss of package integrity that may compromise the sterility of the product. - Terumo Sur-vet Needle, 22G x 3/4", Product Code 100215
FDA Device · Class II · 2019-07-31 · Terumo Medical
Reason: There is a potential for a loss of package integrity that may compromise the sterility of the product. - Terumo Needle, 23G x 1", Product Code NN2325R
FDA Device · Class II · 2019-07-31 · Terumo Medical
Reason: There is a potential for a loss of package integrity that may compromise the sterility of the product. - SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, SR-2425, SR-2435
FDA Device · Class I · 2019-06-05 · Terumo Medical
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. - Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20
FDA Device · Class I · 2019-06-05 · Terumo Medical
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. - SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, STFI-1435, STFI-1625, STFI-1635, STFI-1825, STFI-1835, STFI-1925,…
FDA Device · Class I · 2019-06-05 · Terumo Medical
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. - Angio-Seal Evolution Vascular Closure Device, Cat
FDA Device · Class II · 2018-07-11 · Terumo Medical
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… - Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination¿ Guiding Sheath is designed to be used…
FDA Device · Class II · 2018-03-07 · Terumo Medical
Reason: The tucking depth feature of this catheter introducer is marginally outside the upper specification. - Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 16CM (0.021), REF/Product Code RM*RS5F16PA, STERILE, Rx ONLY
FDA Device · Class II · 2017-12-20 · Terumo Medical
Reason: An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the… - Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*CS7F10NA, STERILE, Rx ONLY
FDA Device · Class II · 2017-12-20 · Terumo Medical
Reason: An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the… - Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*RS7F10PA, STERILE, Rx ONLY
FDA Device · Class II · 2017-12-20 · Terumo Medical
Reason: An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the… - Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.025), REF/Product Code RM*RS6J10PA, STERILE, Rx ONLY
FDA Device · Class II · 2017-12-20 · Terumo Medical
Reason: An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the… - Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*CS6F10NA, STERILE, Rx ONLY
FDA Device · Class II · 2017-12-20 · Terumo Medical
Reason: An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the… - Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.025), REF/Product Code RM*ES5J10HAT, STERILE, Rx ONLY
FDA Device · Class II · 2017-12-20 · Terumo Medical
Reason: An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the… - Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.025), REF/Product Code RM*RS5J10PA, STERILE, Rx ONLY
FDA Device · Class II · 2017-12-20 · Terumo Medical
Reason: An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the… - Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 16CM (0.021), REF/Product Code RM*ES5F16HAU, STERILE, Rx ONLY
FDA Device · Class II · 2017-12-20 · Terumo Medical
Reason: An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the… - Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 16CM (0.021), REF/Product Code RM*RS7F16PA, STERILE, Rx ONLY
FDA Device · Class II · 2017-12-20 · Terumo Medical
Reason: An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the… - Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 16CM (0.021), REF/Product Code RM*ES6F16HAU, STERILE, Rx ONLY
FDA Device · Class II · 2017-12-20 · Terumo Medical
Reason: An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the… - Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 16CM (0.021), REF/Product Code RM*RS6F16PA, STERILE, Rx ONLY
FDA Device · Class II · 2017-12-20 · Terumo Medical
Reason: An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the… - Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*CS5F10NA, STERILE, Rx ONLY
FDA Device · Class II · 2017-12-20 · Terumo Medical
Reason: An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the… - Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.025), REF/Product Code RM*ES6J10HAT, STERILE, Rx ONLY
FDA Device · Class II · 2017-12-20 · Terumo Medical
Reason: An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the… - Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA, STERILE, Rx ONLY
FDA Device · Class II · 2017-12-20 · Terumo Medical
Reason: An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the… - Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.021), REF/Product Code RM*ES6F10HAU, STERILE, Rx ONLY
FDA Device · Class II · 2017-12-20 · Terumo Medical
Reason: An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the… - Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*RS5F10PA, STERILE, Rx ONLY
FDA Device · Class II · 2017-12-20 · Terumo Medical
Reason: An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the… - Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.021), REF/Product Code RM*ES5F10HAU, STERILE, Rx ONLY
FDA Device · Class II · 2017-12-20 · Terumo Medical
Reason: An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the… - Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature
FDA Device · Class II · 2017-05-10 · Terumo Medical
Reason: Based on internal investigation and testing that revealed the distal end of certain lots of Terumo Medical Destination¿ products may not contain the labeled 5 cm of coating. While there have been no complaints or patien… - SurFlo IV Catheter
FDA Device · Class II · 2017-05-10 · Terumo Medical
Reason: According to the Terumo (TMC) this device is used to access the human peripheral vascular system for short term use (less than 30 days) for the purpose of infusing fluids into patients. A small percentage of the cathete… - MISAGO RX Self Expanding Peripheral Stem
FDA Device · Class II · 2016-12-07 · Terumo Medical
Reason: During recent routine testing, the MISAGO Peripheral Stent was found not to conform to product specification related to stent diameter at the proximal/distal ends and/or the shape of the stent. - PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer Sheath PINNACLE¿ R/O II Radiopaque Marke…
FDA Device · Class II · 2016-09-14 · Terumo Medical
Reason: Terumo Medical is initiating this recall due to complaints of valve leakage that have been related to a manufacturing issue. If affected introducer sheaths are used, there is possible risk of incremental blood loss thro… - Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35
FDA Device · Class II · 2015-12-30 · Terumo Medical
Reason: Potential improper bonding between the tube and luer for certain lots of Surflo Winged Infusion Set with Filter and Needle Protection (Surshield). - Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060
FDA Device · Class II · 2013-07-03 · Terumo Medical
Reason: Medical devices were incorrectly labeled with extended expiration dates. - Pinnacle¿ Destination¿ Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve
FDA Device · Class II · 2013-07-03 · Terumo Medical
Reason: Medical devices were incorrectly labeled with extended expiration dates.