Stryker Sustainability Solutions

Complete recall history across all FDA and CPSC categories — 38 total recalls

Stryker Sustainability Solutions appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (38)

FDA medical device enforcement actions by Stryker Sustainability Solutions

Date Product Reason Class
Apr 10, 2026 BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CA... Incomplete seals on sterile product Class II
Apr 10, 2026 BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOL... Incomplete seals on sterile product Class II
Apr 10, 2026 BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHY... Incomplete seals on sterile product Class II
Apr 10, 2026 Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY... Incomplete seals on sterile product Class II
Apr 10, 2026 Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY... Incomplete seals on sterile product Class II
Apr 10, 2026 Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY... Incomplete seals on sterile product Class II
Apr 10, 2026 CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYS... Incomplete seals on sterile product Class II
Apr 10, 2026 BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLO... Incomplete seals on sterile product Class II
Apr 10, 2026 Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY... Incomplete seals on sterile product Class II
Apr 10, 2026 Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY... Incomplete seals on sterile product Class II
Apr 10, 2026 BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLO... Incomplete seals on sterile product Class II
Apr 10, 2026 Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY... Incomplete seals on sterile product Class II
Apr 10, 2026 Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLO... Incomplete seals on sterile product Class II
Apr 10, 2026 Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY... Incomplete seals on sterile product Class II
Apr 10, 2026 Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY... Incomplete seals on sterile product Class II
Apr 10, 2026 BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIO... Incomplete seals on sterile product Class II
Apr 10, 2026 CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYS... Incomplete seals on sterile product Class II
Apr 10, 2026 Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIO... Incomplete seals on sterile product Class II
Apr 10, 2026 Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY... Incomplete seals on sterile product Class II
Apr 10, 2026 BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOL... Incomplete seals on sterile product Class II
Apr 10, 2026 Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY... Incomplete seals on sterile product Class II
Apr 10, 2026 Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY... Incomplete seals on sterile product Class II
Apr 10, 2026 BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHY... Incomplete seals on sterile product Class II
Apr 10, 2026 Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY... Incomplete seals on sterile product Class II
Apr 10, 2026 BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIO... Incomplete seals on sterile product Class II
Apr 10, 2026 BARD Dynamic Tip Steerable, Product Number 6DYNTP001; Incomplete seals on sterile product Class II
Mar 12, 2026 Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Po... Due to potential for tourniquet cuffs to detach from the bladder at the weldi... Class II
Sep 24, 2025 HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F,... Due to manufacturing issue, reprocessed shears, may become stuck in the "on p... Class II
Jul 2, 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... Class II
May 31, 2024 REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, si... Mislabeling; tourniquet cuff packaging labeled as dual port single bladder ... Class II
May 10, 2024 Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic E... Diagnostic electrophysiology (EP) catheters do not meet testing requirements. Class II
Jun 21, 2023 HoverMatt, 39" W x 78" L, REF: HM39SPU-B 39-inche-wide inflatable air transfer mattress packages contain 34-Inch-wide ... Class II
Apr 14, 2023 REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only N... Through complaint surveillance, it was identified that reprocessed Deep vein ... Class II
Mar 1, 2023 Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5... Increased incidence of disposable tourniquet cuffs "not able to achieve desir... Class II
Jan 21, 2022 REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, ... Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder infl... Class II
Jan 19, 2021 Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmon... Product was distributed without receiving regulatory clearance. Class II
Mar 27, 2020 Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Ju... A subset of temporary intracardiac ultrasound catheters are labeled with the ... Class II
Oct 9, 2019 Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number... Tourniquet cuffs are potentially mislabeled. If used may lead to (1) Device m... Class II
Dec 17, 2018 BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnos... Stryker s Sustainability Solutions division (SSS) has received an increase in... Class II
Aug 23, 2018 Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Cath... Electrophysiology catheters were identified to be item # D134903 and distribu... Class II
Jul 27, 2018 Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers A... Affected lots of reprocessed arthroscopic shavers may display the incorrect c... Class II
Jun 19, 2018 Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopi... Through investigation, it was determined that H12LP Trocars in scope of a pre... Class II
May 8, 2018 Reprocessed HARMONIC Ace¿ +7, 5mm Diameter Shears with Advanced Hemostasis (H... Stryker Sustainability Solutions has received an increase in reports indicati... Class II
Mar 29, 2018 Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Cathete... Thrombogenicity test results demonstrated that both the test devices (SSS) an... Class II
Jan 2, 2018 Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable D... An EEPROM chip error code may occur when the catheters are used with CARTO EP... Class II
Jan 2, 2018 Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable D... An EEPROM chip error code may occur when the catheters are used with CARTO EP... Class II
Dec 1, 2017 3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL ... 3040 compression sleeves being mislabeled as a 3010-PL compression sleeves. Class II
Dec 6, 2016 Reprocessed Electrophysiology Catheter Cables Catalog Number: CB3434CT, D134... A breach in the sterile packaging may have occurred resulting in potentially ... Class II
Dec 6, 2016 Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT, CR3434CT Ab... A breach in the sterile packaging may have occurred resulting in potentially ... Class II
Nov 11, 2016 Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endosco... An increase in reports indicating that the reprocessed H12LP Trocar adjustabl... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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