Stryker Sustainability Solutions
FDA Regulatory Profile
Stryker Sustainability Solutions appears in FDA public data with 65 recalls — including 2 Class I (most serious) —, 34 510(k) clearances, 9 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2189-2026, Class II) was initiated on April 10, 2026. Its most recent 510(k) clearance was granted on June 18, 2026.
Summary
- Total Recalls
- 65 (2 Class I)
- 510(k) Clearances
- 34
- Inspections
- 9
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2189-2026 | Class II | Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER | April 10, 2026 |
| Z-2185-2026 | Class II | CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER | April 10, 2026 |
| Z-2186-2026 | Class II | Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER | April 10, 2026 |
| Z-2174-2026 | Class II | BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER | April 10, 2026 |
| Z-2195-2026 | Class II | Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER | April 10, 2026 |
| Z-2199-2026 | Class II | Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER | April 10, 2026 |
| Z-2192-2026 | Class II | Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER | April 10, 2026 |
| Z-2182-2026 | Class II | BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER | April 10, 2026 |
| Z-2198-2026 | Class II | Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER | April 10, 2026 |
| Z-2187-2026 | Class II | Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER | April 10, 2026 |
| Z-2180-2026 | Class II | BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER | April 10, 2026 |
| Z-2194-2026 | Class II | Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER | April 10, 2026 |
| Z-2181-2026 | Class II | BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER | April 10, 2026 |
| Z-2177-2026 | Class II | BARD Dynamic Tip Steerable, Product Number 6DYNTP001; | April 10, 2026 |
| Z-2190-2026 | Class II | Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER | April 10, 2026 |
| Z-2188-2026 | Class II | Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER | April 10, 2026 |
| Z-2176-2026 | Class II | BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER | April 10, 2026 |
| Z-2193-2026 | Class II | Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER | April 10, 2026 |
| Z-2191-2026 | Class II | Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER | April 10, 2026 |
| Z-2184-2026 | Class II | CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER | April 10, 2026 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating | June 18, 2026 |
| K250898 | Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced | August 14, 2025 |
| K241758 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor ( | October 22, 2024 |
| K241606 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 She | July 3, 2024 |
| K233471 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 She | February 20, 2024 |
| K231621 | Reprocessed ViewFlex Xtra ICE Catheter (D087031) | July 25, 2023 |
| K230255 | Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019 | March 28, 2023 |
| K230251 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) | March 28, 2023 |
| K222019 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4 | December 4, 2022 |
| K220481 | Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) | May 25, 2022 |
| K220411 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) | May 13, 2022 |
| K211138 | Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pul | March 8, 2022 |
| K211140 | Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (186 | March 8, 2022 |
| K202554 | Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis | March 16, 2021 |
| K201756 | Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reproces | September 25, 2020 |
| K201511 | Reprocessed Endoscopic Trocars and Sleeves | July 31, 2020 |
| K200205 | Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled | May 13, 2020 |
| K182238 | Reprocessed ViewFlex Xtra ICE Catheter | May 8, 2019 |
| K181056 | Reprocessed CS Diagnostic Electrophysiology Catheter | January 24, 2019 |
| K180499 | Reprocessed LigaSure Maryland Jaw Sealer/Divider | April 23, 2018 |