Stryker Recalls
192 recalls on record · May 18, 2016 to August 12, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 4, 2019Medical DevicesFDA
Stryker GmbH recalls Endotrac ECTR Triangle Blade, Catalog Number 2054-1 The EPF system is designed for the treatment of plantar fasciosi
Hazard: The seal integrity of the sterile bag containing the kits may be compromised.
September 4, 2019Medical DevicesFDA
Stryker GmbH recalls Endotrac ECTR Push Blade, Catalog Number 2053-1 The EPF system is designed for the treatment of plantar fasciosis. T
Hazard: The seal integrity of the sterile bag containing the kits may be compromised.
September 4, 2019Medical DevicesFDA
Stryker GmbH recalls Endotrig ETF Hook Blade, Catalog Number 1052-1 The EPF system is designed for the treatment of plantar fasciosis. The
Hazard: The seal integrity of the sterile bag containing the kits may be compromised.
June 26, 2019Medical DevicesFDA
Stryker GmbH recalls Endotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1
Hazard: The seal integrity of the sterile bag containing the kits may be compromised.
June 26, 2019Medical DevicesFDA
Stryker GmbH recalls Endotrac ECTR Hook/Triangle Blade Kit, Catalogue Number 2056-1
Hazard: The seal integrity of the sterile bag containing the kits may be compromised.
June 12, 2019Medical DevicesFDA
Stryker Corporation recalls Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-690, an accessory to the PNEUMO SURE High Fl
Hazard: The heated tube sets were consistently leaking and detaching from the cassette.
June 12, 2019Medical DevicesFDA
Stryker Corporation recalls Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-680, an accessory to the PNEUMO SURE High
Hazard: The heated tube sets were consistently leaking and detaching from the cassette.
June 12, 2019Medical DevicesFDA
Stryker Corporation recalls Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx,
Hazard: The heated tube sets were consistently leaking and detaching from the cassette.
March 13, 2019Medical DevicesFDA
Stryker GmbH recalls Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage: Knee Arthroplasty
Hazard: The faceplates may incorrectly identify the T2 Basic Long Instrument Set as T2 Basic Short Instrument Set.
November 7, 2018Medical DevicesFDA
Stryker GmbH recalls Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040. Product Usage - The Hoffmann LRF System is
Hazard: The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a reduced press fit of the pin. This can result in partial of full displacement or loss of the pin and, accordingly, stability of the strut of the frame cannot be ensured.
November 7, 2018Medical DevicesFDA
Stryker GmbH recalls Hoffman LRF Hexapod Strut, Extra Short 131mm-191mm, Model Number 4935-0-030. Product Usage - The Hoffmann LRF System is
Hazard: The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a reduced press fit of the pin. This can result in partial of full displacement or loss of the pin and, accordingly, stability of the strut of the frame cannot be ensured.
November 7, 2018Medical DevicesFDA
Stryker GmbH recalls Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm, Model Number 4935-0-020. Product Usage - The Hoffmann LRF System is
Hazard: The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a reduced press fit of the pin. This can result in partial of full displacement or loss of the pin and, accordingly, stability of the strut of the frame cannot be ensured.
November 7, 2018Medical DevicesFDA
Stryker GmbH recalls Hoffman LRF Hexapod Strut, Extra Short 89mm-109mm, Model Number 4935-0-010. Product Usage - The Hoffmann LRF System is i
Hazard: The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a reduced press fit of the pin. This can result in partial of full displacement or loss of the pin and, accordingly, stability of the strut of the frame cannot be ensured.
October 3, 2018Medical DevicesFDA
Stryker GmbH recalls Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002
Hazard: When creating a correction plan with the Correct Axial First button selected and the No. of corrections per day set to more than 1 (e.g., 2, 3, or 4), the Hexapod Software computes an erroneously accelerated correction plan for the axial portion of the plan.
August 29, 2018Medical DevicesFDA
Stryker GmbH recalls Stryker T2 ANKLE ARTHRODESIS NAIL RIGHT 10MMX200MM Item Number: 1819-1020S T2 ANKLE ARTHRODESIS NAIL RIGHT 12MMX200MM 1
Hazard: Incomplete seal on the Tyvek lid may compromise the sterility of the device
July 18, 2018Medical DevicesFDA
Stryker GmbH recalls Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm, Product Number 18191130S
Hazard: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
July 18, 2018Medical DevicesFDA
Stryker GmbH recalls Ankle Arthrodesis Nail, right T2 Ankle ¿10x300mm, Product Number 18191030S
Hazard: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
July 18, 2018Medical DevicesFDA
Stryker GmbH recalls Femoral Nail, RIGHT T2 GTN ¿14x460 mm, Product Number 18511446S
Hazard: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
July 18, 2018Medical DevicesFDA
Stryker GmbH recalls Femoral Nail, RIGHT T2 GTN ¿9x320 mm, Product Number 18510932S
Hazard: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
July 18, 2018Medical DevicesFDA
Stryker GmbH recalls Femoral Nail, LEFT T2 GTN ¿14x300 mm, Product Number 18501430S
Hazard: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
July 18, 2018Medical DevicesFDA
Stryker GmbH recalls Femoral Nail, LEFT T2 GTN ¿12x360 mm, Product Number 18501236S
Hazard: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
July 18, 2018Medical DevicesFDA
Stryker GmbH recalls Femoral Nail, LEFT T2 GTN ¿10x360 mm, Product Number 18501036S
Hazard: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
July 18, 2018Medical DevicesFDA
Stryker GmbH recalls Femoral Nail, A/R, R1500 T2 Femur ¿12x380 mm, Product Number 18281238S
Hazard: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
July 18, 2018Medical DevicesFDA
Stryker GmbH recalls Femoral Nail, A/R, R1500 T2 Femur ¿12x360 mm, Product Number 18281236S
Hazard: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
July 18, 2018Medical DevicesFDA
Stryker GmbH recalls Femoral Nail, A/R, R1500 T2 Femur ¿12x300 mm, Product Number 18281230S
Hazard: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
July 18, 2018Medical DevicesFDA
Stryker GmbH recalls Femoral Nail, A/R, R1500 T2 Femur ¿10x320 mm, Product Number 18281032S
Hazard: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
July 18, 2018Medical DevicesFDA
Stryker GmbH recalls Femoral Nail, A/R T2 Femur ¿15x240 mm, Product Number 18251524S
Hazard: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
July 18, 2018Medical DevicesFDA
Stryker GmbH recalls Femoral Nail, A/R T2 Femur ¿12x360 mm, Product Number 18251236S
Hazard: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
July 18, 2018Medical DevicesFDA
Stryker GmbH recalls Femoral Nail, A/R T2 Femur ¿10x340 mm, Product Number 18251034S
Hazard: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
July 18, 2018Medical DevicesFDA
Stryker GmbH recalls Femoral Nail, A/R T2 Femur ¿10x320 mm, Product Number 18251032S
Hazard: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.