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Stryker Sustainability Solutions

FDA Regulatory Profile

Summary

Total Recalls
65 (2 Class I)
510(k) Clearances
34
Inspections
9
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2196-2026Class IIDaig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETERApril 10, 2026
Z-2175-2026Class IIBARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETERApril 10, 2026
Z-2193-2026Class IIDaig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETERApril 10, 2026
Z-2182-2026Class IIBARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETERApril 10, 2026
Z-2197-2026Class IIDaig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETERApril 10, 2026
Z-2180-2026Class IIBARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETERApril 10, 2026
Z-2177-2026Class IIBARD Dynamic Tip Steerable, Product Number 6DYNTP001;April 10, 2026
Z-2174-2026Class IIBARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETERApril 10, 2026
Z-2187-2026Class IIDaig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETERApril 10, 2026
Z-2183-2026Class IIBW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETERApril 10, 2026
Z-2191-2026Class IIDaig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETERApril 10, 2026
Z-2181-2026Class IIBARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETERApril 10, 2026
Z-2188-2026Class IIDaig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETERApril 10, 2026
Z-2198-2026Class IIDaig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETERApril 10, 2026
Z-2179-2026Class IIBARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETERApril 10, 2026
Z-2185-2026Class IICS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETERApril 10, 2026
Z-2184-2026Class IICS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETERApril 10, 2026
Z-2199-2026Class IIMedtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETERApril 10, 2026
Z-2186-2026Class IIDaig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETERApril 10, 2026
Z-2176-2026Class IIBARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETERApril 10, 2026

Recent 510(k) Clearances

K-NumberDeviceDate
K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingJune 18, 2026
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
K211138Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed PulMarch 8, 2022
K211140Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (186March 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