Recall archive
37 recalls · page 1 of 2
Reported Oct 14, 2026Updated Oct 20, 2026
BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
Matched: Brand — Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could…
FDA (openFDA device enforcement)
Reported Sep 23, 2026Updated Sep 29, 2026
REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
Matched: Brand — Reusable access port system may crack or seperate during use.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 20, 2026
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
Matched: Brand — Incomplete seals on sterile product
25 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 15, 2026
Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryker…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
Matched: Brand · Product · Product details — 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.
FDA (openFDA device enforcement)
Reported Nov 19, 2025
HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
Matched: Brand — Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.
FDA (openFDA device enforcement)
Reported Aug 28, 2024
Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Jul 24, 2024
REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
Matched: Brand — Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder.
FDA (openFDA device enforcement)
Reported Jul 10, 2024
Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
Matched: Brand · Product · Product details — Diagnostic electrophysiology (EP) catheters do not meet testing requirements.
FDA (openFDA device enforcement)
Reported Aug 16, 2023
HoverMatt, 39" W x 78" L, REF: HM39SPU-B
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
Matched: Brand — 39-inche-wide inflatable air transfer mattress packages contain 34-Inch-wide mattresses, so there may be a decreased surface area available to…
FDA (openFDA device enforcement)
Reported May 24, 2023
REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
Matched: Brand — Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or…
FDA (openFDA device enforcement)
Reported Apr 5, 2023
Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
Matched: Brand — Increased incidence of disposable tourniquet cuffs "not able to achieve desired pressure" and "not holding pressure" due to 1) Cuff fabric tearing…
FDA (openFDA device enforcement)
Reported Mar 2, 2022
REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
Matched: Brand · Product · Product details — Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs.
FDA (openFDA device enforcement)
Reported Apr 7, 2021
Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
Matched: Brand · Product · Product details — Product was distributed without receiving regulatory clearance.
FDA (openFDA device enforcement)
Reported Feb 3, 2021
Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical, Size 9F (3.2mm), Length 90 cm,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
Matched: Brand — A subset of temporary intracardiac ultrasound catheters are labeled with the incorrect expiration date. They are mislabeled as having a shelf life of…
FDA (openFDA device enforcement)
Reported May 6, 2020
Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number: 60-7070-105, UDI: 00885825013868,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
Matched: Brand — Tourniquet cuffs are potentially mislabeled. If used may lead to (1) Device misuse during procedure (2) Inadequate Limb Compression Force.
FDA (openFDA device enforcement)
Reported Mar 13, 2019
Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
Matched: Brand · Product · Product details — Affected lots of reprocessed arthroscopic shavers may display the incorrect catalog number and speed settings when connected to the generator,…
FDA (openFDA device enforcement)
Reported Jan 30, 2019
BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiology (EP) catheters are…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
Matched: Brand · Reason for recall — Stryker s Sustainability Solutions division (SSS) has received an increase in reports indicating that an EEPROM chip error code may occur when…
FDA (openFDA device enforcement)
Reported Dec 5, 2018
Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars12x100mm - Product Usage:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
Matched: Brand — Through investigation, it was determined that H12LP Trocars in scope of a previous H12LP recall were distributed to facilities within the…
FDA (openFDA device enforcement)
Reported Nov 21, 2018
Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
Matched: Brand · Product · Product details — Electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently determined that these catheters are item #…
FDA (openFDA device enforcement)
Reported Jul 25, 2018
Reprocessed HARMONIC Ace¿ +7, 5mm Diameter Shears with Advanced Hemostasis (HARH), Item Number HARH36 Product Usage:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
Matched: Brand · Reason for recall — Stryker Sustainability Solutions has received an increase in reports indicating that the affected Reprocessed HARH36 devices may display an error…
FDA (openFDA device enforcement)
Reported Jul 18, 2018
Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter, catalog numbers D135303 and D135304.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
Matched: Brand — Thrombogenicity test results demonstrated that both the test devices (SSS) and control devices (OM) did not meet the internal specification of…
FDA (openFDA device enforcement)
Reported Mar 14, 2018
Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134301,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
Matched: Brand · Product · Product details — An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 27, 2017
3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL Aircast Pos-Lock Connector. Intended for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
Matched: Brand — 3040 compression sleeves being mislabeled as a 3010-PL compression sleeves.
FDA (openFDA device enforcement)
Reported Jan 18, 2017
Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT, CR3434CT Ablation catheter cables are designed as…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
Matched: Brand — A breach in the sterile packaging may have occurred resulting in potentially non-sterile product.
1 more product in this recall
FDA (openFDA device enforcement)
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