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Stryker Sustainability Solutions FDA Recalls
42 recalls on file across devices, 0 of them Class I and 41 still open. Matched by name to SYK.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| REF:2B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 100MMClass IIAug 19, 2026Reusable access port system may crack or seperate during use |
| REF:B11LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 11X100MMClass IIAug 19, 2026Reusable access port system may crack or seperate during use |
| REF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MMClass IIAug 19, 2026Reusable access port system may crack or seperate during use |
| REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MMClass IIAug 19, 2026Reusable access port system may crack or seperate during use |
| REF:B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X75MMClass IIAug 19, 2026Reusable access port system may crack or seperate during use |
| REF:B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X100MMClass IIAug 19, 2026Reusable access port system may crack or seperate during use |
| BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETERClass IIApr 10, 2026Incomplete seals on sterile product |
| BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETERClass IIApr 10, 2026Incomplete seals on sterile product |
| BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETERClass IIApr 10, 2026Incomplete seals on sterile product |
| Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETERClass IIApr 10, 2026Incomplete seals on sterile product |
| Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETERClass IIApr 10, 2026Incomplete seals on sterile product |
| BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETERClass IIApr 10, 2026Incomplete seals on sterile product |
| Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETERClass IIApr 10, 2026Incomplete seals on sterile product |
| Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETERClass IIApr 10, 2026Incomplete seals on sterile product |
| BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETERClass IIApr 10, 2026Incomplete seals on sterile product |
| BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETERClass IIApr 10, 2026Incomplete seals on sterile product |
| BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETERClass IIApr 10, 2026Incomplete seals on sterile product |
| Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETERClass IIApr 10, 2026Incomplete seals on sterile product |
| Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETERClass IIApr 10, 2026Incomplete seals on sterile product |
| Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETERClass IIApr 10, 2026Incomplete seals on sterile product |
| Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETERClass IIApr 10, 2026Incomplete seals on sterile product |
| CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETERClass IIApr 10, 2026Incomplete seals on sterile product |
| Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETERClass IIApr 10, 2026Incomplete seals on sterile product |
| Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETERClass IIApr 10, 2026Incomplete seals on sterile product |
| Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETERClass IIApr 10, 2026Incomplete seals on sterile product |
| BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETERClass IIApr 10, 2026Incomplete seals on sterile product |
| BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETERClass IIApr 10, 2026Incomplete seals on sterile product |
| BARD Dynamic Tip Steerable, Product Number 6DYNTP001;Class IIApr 10, 2026Incomplete seals on sterile product |
| Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETERClass IIApr 10, 2026Incomplete seals on sterile product |
| Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETERClass IIApr 10, 2026Incomplete seals on sterile product |
| Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETERClass IIApr 10, 2026Incomplete seals on sterile product |
| CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETERClass IIApr 10, 2026Incomplete seals on sterile product |
| Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 StrykClass IIMar 12, 2026Due to potential for tourniquet cuffs to detach from the bla |
| HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERClass IISep 24, 2025Due to manufacturing issue, reprocessed shears, may become s |
| Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5AClass IIJul 2, 2024Disposable 5 lead cable and lead wire system package that sh |
| REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnlyClass IIMay 31, 2024Mislabeling; tourniquet cuff packaging labeled as dual port |
| Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, Class IIMay 10, 2024Diagnostic electrophysiology (EP) catheters do not meet test |
| HoverMatt, 39" W x 78" L, REF: HM39SPU-BClass IIJun 21, 202339-inche-wide inflatable air transfer mattress packages cont |
| REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-SterileClass IIApr 14, 2023Through complaint surveillance, it was identified that repro |
| Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Class IIMar 1, 2023Increased incidence of disposable tourniquet cuffs "not able |
| REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single BladderClass IIJan 21, 2022Mislabeling; dual-bladder tourniquet cuffs are labeled as si |
| Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis Class IIJan 19, 2021Product was distributed without receiving regulatory clearan |