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Terumo Medical Recalls
39 recalls on record · July 3, 2013 to August 19, 2026 · Medical Devices
Recalls by year
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26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 19, 2026Medical DevicesFDA
Terumo Medical Corporation recalls GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to
Hazard: Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
July 31, 2019Medical DevicesFDA
Terumo Medical Corporation recalls Terumo Needle, 30G x 1/2", Product Code NN3013R
Hazard: There is a potential for a loss of package integrity that may compromise the sterility of the product.
July 31, 2019Medical DevicesFDA
Terumo Medical Corporation recalls Terumo Needle, 23G x 1", Product Code NN2325R
Hazard: There is a potential for a loss of package integrity that may compromise the sterility of the product.
July 31, 2019Medical DevicesFDA
Terumo Medical Corporation recalls Terumo Needle, 18G x 1", Product Code NN1825R
Hazard: There is a potential for a loss of package integrity that may compromise the sterility of the product.
July 31, 2019Medical DevicesFDA
Terumo Medical Corporation recalls Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280
Hazard: There is a potential for a loss of package integrity that may compromise the sterility of the product.
July 31, 2019Medical DevicesFDA
Terumo Medical Corporation recalls Terumo Sur-vet Needle, 22G x 3/4", Product Code 100279
Hazard: There is a potential for a loss of package integrity that may compromise the sterility of the product.
July 31, 2019Medical DevicesFDA
Terumo Medical Corporation recalls Terumo Sur-vet Needle, 25G x 5/8", Product Code 100220
Hazard: There is a potential for a loss of package integrity that may compromise the sterility of the product.
July 31, 2019Medical DevicesFDA
Terumo Medical Corporation recalls Terumo Sur-vet Needle, 22G x 3/4", Product Code 100215
Hazard: There is a potential for a loss of package integrity that may compromise the sterility of the product.
July 31, 2019Medical DevicesFDA
Terumo Medical Corporation recalls Terumo Sur-vet Needle, 22G x 1", Product Code 100211
Hazard: There is a potential for a loss of package integrity that may compromise the sterility of the product.
July 31, 2019Medical DevicesFDA
Terumo Medical Corporation recalls Terumo Sur-vet Needle, 20G x 1", Product Code 100204
Hazard: There is a potential for a loss of package integrity that may compromise the sterility of the product.
June 5, 2019Medical DevicesFDA
Terumo Medical Corporation recalls Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20
Hazard: 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.
June 5, 2019Medical DevicesFDA
Terumo Medical Corporation recalls SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, S
Hazard: 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.
June 5, 2019Medical DevicesFDA
Terumo Medical Corporation recalls SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, STFI-1435, STFI-1625, STFI-1635, STFI-
Hazard: 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.
July 11, 2018Medical DevicesFDA
Terumo Medical Corp recalls Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135
Hazard: 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.
March 7, 2018Medical DevicesFDA
Terumo Medical Corporation recalls Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination¿ Guiding Sheath
Hazard: The tucking depth feature of this catheter introducer is marginally outside the upper specification.
December 20, 2017Medical DevicesFDA
Terumo Medical Corp recalls Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 16CM (0.021), REF/Product Code RM*RS7F16PA, STERILE, Rx
Hazard: 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 sterile barrier may compromise the sterility of the sheath.
December 20, 2017Medical DevicesFDA
Terumo Medical Corp recalls Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*RS7F10PA, STERILE, Rx
Hazard: 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 sterile barrier may compromise the sterility of the sheath.
December 20, 2017Medical DevicesFDA
Terumo Medical Corp recalls Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.025), REF/Product Code RM*RS6J10PA, STERILE, Rx
Hazard: 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 sterile barrier may compromise the sterility of the sheath.
December 20, 2017Medical DevicesFDA
Terumo Medical Corp recalls Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 16CM (0.021), REF/Product Code RM*RS6F16PA, STERILE, Rx
Hazard: 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 sterile barrier may compromise the sterility of the sheath.
December 20, 2017Medical DevicesFDA
Terumo Medical Corp recalls Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA, STERILE, Rx
Hazard: 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 sterile barrier may compromise the sterility of the sheath.
December 20, 2017Medical DevicesFDA
Terumo Medical Corp recalls Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.025), REF/Product Code RM*RS5J10PA, STERILE, Rx
Hazard: 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 sterile barrier may compromise the sterility of the sheath.
December 20, 2017Medical DevicesFDA
Terumo Medical Corp recalls Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 16CM (0.021), REF/Product Code RM*RS5F16PA, STERILE, Rx
Hazard: 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 sterile barrier may compromise the sterility of the sheath.
December 20, 2017Medical DevicesFDA
Terumo Medical Corp recalls Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*RS5F10PA, STERILE, Rx
Hazard: 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 sterile barrier may compromise the sterility of the sheath.
December 20, 2017Medical DevicesFDA
Terumo Medical Corp recalls Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.025), REF/Product Code RM*ES6J10HAT, STERI
Hazard: 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 sterile barrier may compromise the sterility of the sheath.
December 20, 2017Medical DevicesFDA
Terumo Medical Corp recalls Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 16CM (0.021), REF/Product Code RM*ES6F16HAU, STERI
Hazard: 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 sterile barrier may compromise the sterility of the sheath.
December 20, 2017Medical DevicesFDA
Terumo Medical Corp recalls Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.021), REF/Product Code RM*ES6F10HAU, STERI
Hazard: 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 sterile barrier may compromise the sterility of the sheath.
December 20, 2017Medical DevicesFDA
Terumo Medical Corp recalls Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.025), REF/Product Code RM*ES5J10HAT, STERI
Hazard: 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 sterile barrier may compromise the sterility of the sheath.
December 20, 2017Medical DevicesFDA
Terumo Medical Corp recalls Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 16CM (0.021), REF/Product Code RM*ES5F16HAU, STERI
Hazard: 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 sterile barrier may compromise the sterility of the sheath.
December 20, 2017Medical DevicesFDA
Terumo Medical Corp recalls Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.021), REF/Product Code RM*ES5F10HAU, STERI
Hazard: 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 sterile barrier may compromise the sterility of the sheath.
December 20, 2017Medical DevicesFDA
Terumo Medical Corp recalls Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*CS7F10NA, STERILE, Rx
Hazard: 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 sterile barrier may compromise the sterility of the sheath.