Chrysalis Intelligence · Sponsors · Stryker Sustainability Solutions

Stryker Sustainability Solutions

Tempe, AZ, US · 17 510(k) clearances · 37 recalls

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals
Total clearances
17
2020-05-13 → 2026-06-18
Last 12 months
1
Product codes
9
Most recent
2026-06-18
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments Unclassified Unknown 4 2025-08-14
GEI Electrosurgical, Cutting & Coagulation & Accessories Class II General, Plastic Surgery 3 2026-06-18
NLF Oximeter, Reprocessed Class II Cardiovascular 3 2024-10-22
NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed Class II General, Plastic Surgery 2 2023-03-28
OWQ Reprocessed Intravascular Ultrasound Catheter Class II Cardiovascular 1 2023-07-25
DQA — — — 1 2022-03-08
HIH Hysteroscope (And Accessories) Class II Obstetrics/Gynecology 1 2020-09-25
NLM Laparoscope, General & Plastic Surgery, Reprocessed Class II Gastroenterology, Urology 1 2020-07-31
NLH Catheter, Recording, Electrode, Reprocessed Class II Cardiovascular 1 2020-05-13
Safety

Recalls (37)

Class I (serious)
0
Risk of injury / death
Total recalls
37
Currently ongoing
35
Most recent
2026-04-10
DateSeverityStatusRecall # ProductCodeReason
2026-04-10 Class II Ongoing Z-2199-2026 Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER — Incomplete seals on sterile product
2026-04-10 Class II Ongoing Z-2198-2026 Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER — Incomplete seals on sterile product
2026-04-10 Class II Ongoing Z-2197-2026 Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER — Incomplete seals on sterile product
2026-04-10 Class II Ongoing Z-2196-2026 Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER — Incomplete seals on sterile product
2026-04-10 Class II Ongoing Z-2195-2026 Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER — Incomplete seals on sterile product
2026-04-10 Class II Ongoing Z-2194-2026 Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER — Incomplete seals on sterile product
2026-04-10 Class II Ongoing Z-2193-2026 Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER — Incomplete seals on sterile product
2026-04-10 Class II Ongoing Z-2192-2026 Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER — Incomplete seals on sterile product
2026-04-10 Class II Ongoing Z-2191-2026 Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER — Incomplete seals on sterile product
2026-04-10 Class II Ongoing Z-2190-2026 Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER — Incomplete seals on sterile product
2026-04-10 Class II Ongoing Z-2189-2026 Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER — Incomplete seals on sterile product
2026-04-10 Class II Ongoing Z-2188-2026 Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER — Incomplete seals on sterile product
2026-04-10 Class II Ongoing Z-2187-2026 Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER — Incomplete seals on sterile product
2026-04-10 Class II Ongoing Z-2186-2026 Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER — Incomplete seals on sterile product
2026-04-10 Class II Ongoing Z-2185-2026 CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER — Incomplete seals on sterile product
2026-04-10 Class II Ongoing Z-2184-2026 CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER — Incomplete seals on sterile product
2026-04-10 Class II Ongoing Z-2183-2026 BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER — Incomplete seals on sterile product
2026-04-10 Class II Ongoing Z-2182-2026 BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER — Incomplete seals on sterile product
2026-04-10 Class II Ongoing Z-2181-2026 BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER — Incomplete seals on sterile product
2026-04-10 Class II Ongoing Z-2180-2026 BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER — Incomplete seals on sterile product
2026-04-10 Class II Ongoing Z-2179-2026 BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER — Incomplete seals on sterile product
2026-04-10 Class II Ongoing Z-2178-2026 BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER — Incomplete seals on sterile product
2026-04-10 Class II Ongoing Z-2177-2026 BARD Dynamic Tip Steerable, Product Number 6DYNTP001; — Incomplete seals on sterile product
2026-04-10 Class II Ongoing Z-2176-2026 BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER — Incomplete seals on sterile product
2026-04-10 Class II Ongoing Z-2175-2026 BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER — Incomplete seals on sterile product
2026-04-10 Class II Ongoing Z-2174-2026 BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER — Incomplete seals on sterile product
2026-03-12 Class II Ongoing Z-1804-2026 Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryk… — Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure.
2025-09-24 Class II Ongoing Z-0490-2026 HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STER… — Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.
2024-07-02 Class II Ongoing Z-2689-2024 Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A — Disposable 5 lead cable and lead wire system package that should contain lead systems, lead telemetry systems and a dual connect cable, may in fact contain, dif…
2024-05-31 Class II Ongoing Z-2405-2024 REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly — Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder.
2024-05-10 Class II Ongoing Z-2268-2024 Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, … — Diagnostic electrophysiology (EP) catheters do not meet testing requirements.
2023-06-21 Class II Ongoing Z-2394-2023 HoverMatt, 39" W x 78" L, REF: HM39SPU-B — 39-inche-wide inflatable air transfer mattress packages contain 34-Inch-wide mattresses, so there may be a decreased surface area available to distribute the pa…
2023-04-14 Class II Ongoing Z-1612-2023 REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile — Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged.
2023-03-01 Class II Ongoing Z-1315-2023 Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, … — Increased incidence of disposable tourniquet cuffs "not able to achieve desired pressure" and "not holding pressure" due to 1) Cuff fabric tearing during use, a…
2022-01-21 Class II Terminated Z-0664-2022 REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder — Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs.
2021-01-19 Class II Ongoing Z-1327-2021 Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis … — Product was distributed without receiving regulatory clearance.
2020-03-27 Class II Terminated Z-2113-2020 Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical, Size 9F (3.2mm), Length 90 cm, … — A subset of temporary intracardiac ultrasound catheters are labeled with the incorrect expiration date. They are mislabeled as having a shelf life of two years,…
Filings

All 510(k) clearances (17)

Date K-number Device Code Class Specialty
2026-06-18 K260636 Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating GEI Class II General, Plastic Surgery
2025-08-14 K250898 Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm) NLQ Unclassified Unknown
2024-10-22 K241758 Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003) NLF Class II Cardiovascular
2024-07-03 K241606 Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136) NLQ Unclassified Unknown
2024-02-20 K233471 Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136) NLQ Unclassified Unknown
2023-07-25 K231621 Reprocessed ViewFlex Xtra ICE Catheter (D087031) OWQ Class II Cardiovascular
2023-03-28 K230255 Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019 GEI Class II General, Plastic Surgery
2023-03-28 K230251 Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) NUJ Class II General, Plastic Surgery
2022-12-04 K222019 Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003) NLF Class II Cardiovascular
2022-05-25 K220481 Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) GEI Class II General, Plastic Surgery
2022-05-13 K220411 Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) NUJ Class II General, Plastic Surgery
2022-03-08 K211140 Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2 DQA — —
2022-03-08 K211138 Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse Oximeter Sensor (D-20), Reprocessed Pulse Oximeter Sensor (N-25), Reprocessed Pulse Oximeter Sensor (I-20), Reprocessed Pulse Oximeter Sensor (Max-A), Reprocessed Pulse Oximeter Sensor (Max-AL), Reprocessed Pulse Oximeter Sensor (Max-P), Reprocessed Pulse Oximeter Sensor (Max-N), Reprocessed Pulse Oximeter Sensor (Max-I) NLF Class II Cardiovascular
2021-03-16 K202554 Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis NLQ Unclassified Unknown
2020-09-25 K201756 Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device for Fluent HIH Class II Obstetrics/Gynecology
2020-07-31 K201511 Reprocessed Endoscopic Trocars and Sleeves NLM Class II Gastroenterology, Urology
2020-05-13 K200205 Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled NLH Class II Cardiovascular
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence