Company ยท US
Stryker Sustainability Solutions
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2026. Name variants (Inc, Corp, punctuation) are merged.
34510(k) clearances (1 in 12 months)
73recalls (35 in 12 months)
60recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NLH | Catheter, Recording, Electrode, Reprocessed | 42 |
| NLM | Laparoscope, General & Plastic Surgery, Reprocessed | 14 |
| NLQ | Single-Use Reprocessed Ultrasonic Surgical Instruments | 10 |
| KCY | Tourniquet, Pneumatic | 7 |
| NUJ | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed | 7 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 5 |
| OWQ | Reprocessed Intravascular Ultrasound Catheter | 4 |
| JOW | Sleeve, Limb, Compressible | 3 |
| NLF | Oximeter, Reprocessed | 3 |
| BTR | Tube, Tracheal (W/Wo Connector) | 2 |
| DQA | Oximeter | 1 |
| DQO | Catheter, Intravascular, Diagnostic | 1 |
| DYB | Introducer, Catheter | 1 |
| FRZ | Device, Patient Transfer, Powered | 1 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | 1 |
| HIH | Hysteroscope (And Accessories) | 1 |
| HRX | Arthroscope | 1 |
| IKD | Cable, Electrode | 1 |
| KDQ | Bottle, Collection, Vacuum | 1 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 18, 2026 | K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating Stryker Sustainability Solutions | GEI |
| Aug 14, 2025 | K250898 | Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Stryker Sustainability Solutions | NLQ |
| Oct 22, 2024 | K241758 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed R Stryker Sustainability Solutions | NLF |
| Jul 3, 2024 | K241606 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 3 Stryker Sustainability Solutions | NLQ |
| Feb 20, 2024 | K233471 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 3 Stryker Sustainability Solutions | NLQ |
| Jul 25, 2023 | K231621 | Reprocessed ViewFlex Xtra ICE Catheter (D087031) Stryker Sustainability Solutions | OWQ |
| Mar 28, 2023 | K230255 | Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019 Stryker Sustainability Solutions | GEI |
| Mar 28, 2023 | K230251 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) Stryker Sustainability Solutions | NUJ |
| Dec 4, 2022 | K222019 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD Stryker Sustainability Solutions | NLF |
| May 25, 2022 | K220481 | Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) Stryker Sustainability Solutions | GEI |
| May 13, 2022 | K220411 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) Stryker Sustainability Solutions | NUJ |
| Mar 8, 2022 | K211140 | Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Trans Stryker Sustainability Solutions | DQA |
| Mar 8, 2022 | K211138 | Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse Oximeter Sensor ( Stryker Sustainability Solutions | NLF |
| Mar 16, 2021 | K202554 | Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis Stryker Sustainability Solutions | NLQ |
| Sep 25, 2020 | K201756 | Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tis Stryker Sustainability Solutions | HIH |
| Jul 31, 2020 | K201511 | Reprocessed Endoscopic Trocars and Sleeves Stryker Sustainability Solutions | NLM |
| May 13, 2020 | K200205 | Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled Stryker Sustainability Solutions | NLH |
| May 8, 2019 | K182238 | Reprocessed ViewFlex Xtra ICE Catheter Stryker Sustainability Solutions | OWQ |
| Jan 24, 2019 | K181056 | Reprocessed CS Diagnostic Electrophysiology Catheter Stryker Sustainability Solutions | NLH |
| Apr 23, 2018 | K180499 | Reprocessed LigaSure Maryland Jaw Sealer/Divider Stryker Sustainability Solutions | NUJ |
| Apr 20, 2018 | K180451 | Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider Stryker Sustainability Solutions | NUJ |
| Nov 16, 2017 | K172856 | Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider Stryker Sustainability Solutions | GEI |
| Apr 5, 2017 | K170456 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology Stryker Sustainability Solutions | NLQ |
| Feb 23, 2017 | K161693 | Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis Stryker Sustainability Solutions | NLQ |
| Jan 13, 2016 | K153415 | Reprocessed Stryker External Fixation Devices Stryker Sustainability Solutions | KTT |
| Jun 25, 2015 | K150538 | Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/Divider Stryker Sustainability Solutions | NUJ |
| May 1, 2014 | K133672 | REPROCESSED HARMONIC ACE SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY Stryker Sustainability Solutions | NLQ |
| Apr 10, 2014 | K133578 | REPROCESSED LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER Stryker Sustainability Solutions | NUJ |
| Dec 31, 2013 | K132629 | REPROCESSED DILATING TIP TROCARS Stryker Sustainability Solutions | NLM |
| Jan 24, 2013 | K123334 | REPROCESSED STEERABLE INTRODUCER Stryker Sustainability Solutions, Inc. | DYB |
| Dec 20, 2012 | K121913 | REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETER Stryker Sustainability Solutions, Inc. | OWQ |
| Aug 16, 2012 | K121855 | RESPROCESSED SERFAS ENERGY PROBE Stryker Sustainability Solutions | NUJ |
| Oct 21, 2011 | K112292 | REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER Stryker Sustainability Solutions | NLH |
| Sep 26, 2011 | K112232 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS Stryker Sustainability Solutions | NLH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 5, 2026 | Stryker Sustainability Solutions BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007 Open, Classified |
NLH | K030187 |
| Sep 16, 2026 | Stryker Sustainability Solutions REF:B5ST
Ethicon Endo-Surgery, Inc.
XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X75MM Open, Classified |
NLM | K201511 |
| Sep 16, 2026 | Stryker Sustainability Solutions REF:B5LT
Ethicon Endo-Surgery, Inc.
XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X100MM Open, Classified |
NLM | K201511 |
| Sep 16, 2026 | Stryker Sustainability Solutions REF:B12LT
Ethicon Endo-Surgery, Inc.
XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MM Open, Classified |
NLM | K201511 |
| Sep 16, 2026 | Stryker Sustainability Solutions REF:B11LT
Ethicon Endo-Surgery, Inc.
XCEL BLADELESS TROCAR W/STABILITY SLEEVE 11X100MM Open, Classified |
NLM | K201511 |
| Sep 16, 2026 | Stryker Sustainability Solutions REF:2B5ST
Ethicon Endo-Surgery, Inc.
XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM Open, Classified |
NLM | K201511 |
| Sep 16, 2026 | Stryker Sustainability Solutions REF:2B5LT
Ethicon Endo-Surgery, Inc.
XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 100MM Open, Classified |
NLM | K201511 |
| May 13, 2026 | Stryker Sustainability Solutions Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions BARD Dynamic Tip Steerable, Product Number 6DYNTP001; Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| Apr 9, 2026 | Stryker Sustainability Solutions Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235
Stryker Sustainability Solution Color Cuff 18" (Red), Quick Connect Dual Port Single Bl Open, Classified |
KCY | None listed |
| Nov 12, 2025 | Stryker Sustainability Solutions HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length
REF: HAR9F,
Reprocessed Device for Single Use, STERILEEO, RX ONLY Open, Classified |
NLQ | K170456 |
| Aug 20, 2024 | Stryker Sustainability Solutions Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A Open, Classified |
IKD | None listed |
| Jul 17, 2024 | Stryker Sustainability Solutions REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly Open, Classified |
KCY | None listed |
| Jul 3, 2024 | Stryker Sustainability Solutions Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 cm, STERILE.EO, Rx Only Open, Classified |
NLH | K112292 |
| Aug 11, 2023 | Stryker Sustainability Solutions HoverMatt, 39" W x 78" L, REF: HM39SPU-B Open, Classified |
FRZ | None listed |
| May 19, 2023 | Stryker Sustainability Solutions REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile Open, Classified |
JOW | K100909 |
| Apr 1, 2023 | Stryker Sustainability Solutions Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135;
Color Cuff Dual Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-235;
Color Open, Classified |
KCY | None listed |
| Jan 21, 2022 | Stryker Sustainability Solutions REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder Terminated |
KCY | None listed |
| Jan 19, 2021 | Stryker Sustainability Solutions Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis 5mm Diameter x 36cm - Product Usage: indicated for soft tissue incisions when bl Open, Classified |
NLQ | K161693 |
| Jun 1, 2020 | Stryker Sustainability Solutions Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical, Size 9F (3.2mm), Length 90 cm, Sterile EO, Rx Only, Quantity 1, UDI: 07613327376067 Terminated |
OWQ | K182238 |
| Oct 9, 2019 | Stryker Sustainability Solutions Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number: 60-7070-105, UDI: 00885825013868, Reprocessed Tourniquet Cuff - Product Usage: Reprocessed tourniquet cuffs are indicated Terminated |
KCY | None listed |
| Dec 17, 2018 | Stryker Sustainability Solutions BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301
Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be Terminated |
NLH | K112292 |
| Aug 23, 2018 | Stryker Sustainability Solutions Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart. Terminated |
NLH | K112292 |
| Jul 27, 2018 | Stryker Sustainability Solutions Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers
Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in Terminated |
HRX | K012605 |
| Jun 19, 2018 | Stryker Sustainability Solutions Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars12x100mm - Product Usage: Physical Product Description: The Reprocessed Blunt Tip Trocar consists of a radiolucent Terminated |
NLM | K062497 |
| May 8, 2018 | Stryker Sustainability Solutions Reprocessed HARMONIC Ace +7, 5mm Diameter Shears with Advanced Hemostasis (HARH), Item Number HARH36
Product Usage:
The Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis are i Terminated |
NLQ | K161693 |
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