Stryker Sustainability Solutions

FDA Regulatory Profile

Summary

Total Recalls
38 (2 Class I)
510(k) Clearances
33
Inspections
9
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0490-2026Class IIHARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device fSeptember 24, 2025
Z-2689-2024Class IIDisposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5AJuly 2, 2024
Z-2405-2024Class IIREF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnlyMay 31, 2024
Z-2268-2024Class IIStryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D13430May 10, 2024
Z-2394-2023Class IIHoverMatt, 39" W x 78" L, REF: HM39SPU-BJune 21, 2023
Z-1612-2023Class IIREF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-SterileApril 14, 2023
Z-1315-2023Class IIColor Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; CoMarch 1, 2023
Z-0664-2022Class IIREF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single BladderJanuary 21, 2022
Z-1327-2021Class IIStryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with January 19, 2021
Z-2113-2020Class IICardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical, Size 9F (3.March 27, 2020
Z-1802-2020Class IIZimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number: 60-7070-105, UDI: 008October 9, 2019
Z-0766-2019Class IIBW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiology (December 17, 2018
Z-0467-2019Class IIStryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtaiAugust 23, 2018
Z-0973-2019Class IIStryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers canJuly 27, 2018
Z-0498-2019Class IIReprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars12x100mm - ProJune 19, 2018
Z-2484-2018Class IIReprocessed HARMONIC Ace¿ +7, 5mm Diameter Shears with Advanced Hemostasis (HARH), Item Number HARH3May 8, 2018
Z-2426-2018Class IICoronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter, catalog numbers D135March 29, 2018
Z-0916-2018Class IIStryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters,January 2, 2018
Z-0917-2018Class IIStryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters,January 2, 2018
Z-0272-2018Class II3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL Aircast Pos-Lock ConnecDecember 1, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K250898Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced August 14, 2025
K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (October 22, 2024
K241606Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 SheJuly 3, 2024
K233471Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 SheFebruary 20, 2024
K231621Reprocessed ViewFlex Xtra ICE Catheter (D087031)July 25, 2023
K230251Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)March 28, 2023
K230255Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019March 28, 2023
K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4December 4, 2022
K220481Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)May 25, 2022
K220411Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)May 13, 2022
K211140Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (186March 8, 2022
K211138Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed PulMarch 8, 2022
K202554Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced HemostasisMarch 16, 2021
K201756Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, ReprocesSeptember 25, 2020
K201511Reprocessed Endoscopic Trocars and SleevesJuly 31, 2020
K200205Reprocessed Advisor FL Circular Mapping Catheter, Sensor EnabledMay 13, 2020
K182238Reprocessed ViewFlex Xtra ICE CatheterMay 8, 2019
K181056Reprocessed CS Diagnostic Electrophysiology CatheterJanuary 24, 2019
K180499Reprocessed LigaSure Maryland Jaw Sealer/DividerApril 23, 2018
K180451Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/DividerApril 20, 2018