Stryker Sustainability Solutions REF:2B5ST Ethicon Endo-Surgery, Inc recall — FDA Z-3183-2026
Reusable access port system may crack or seperate during use.
Overview of recall records associated with Stryker Sustainability Solutions, including dates, categories and classifications where available.
Classification mix: Class II: 23.
Reusable access port system may crack or seperate during use.
Reusable access port system may crack or seperate during use.
Reusable access port system may crack or seperate during use.
Reusable access port system may crack or seperate during use.
Reusable access port system may crack or seperate during use.
Reusable access port system may crack or seperate during use.
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.
Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.
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, different ECG Leads, which are…
Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder.
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 patient's weight across, which…
Increased incidence of disposable tourniquet cuffs "not able to achieve desired pressure" and "not holding pressure" due to 1) Cuff fabric tearing during use, and 2) Pinched or unseated…
Product was distributed without receiving regulatory clearance.
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, while the actual shelf life…
Tourniquet cuffs are potentially mislabeled. If used may lead to (1) Device misuse during procedure (2) Inadequate Limb Compression Force.
Affected lots of reprocessed arthroscopic shavers may display the incorrect catalog number and speed settings when connected to the generator, require manual mode for use on CORE…
Stryker s Sustainability Solutions division (SSS) has received an increase in reports indicating that an EEPROM chip error code may occur when Reprocessed 2515 NAV eco Variable…
Through investigation, it was determined that H12LP Trocars in scope of a previous H12LP recall were distributed to facilities within the distribution chain following the recall execution…
Electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently determined that these catheters are item # D134909, which is not approved for…
Stryker Sustainability Solutions has received an increase in reports indicating that the affected Reprocessed HARH36 devices may display an error code (No Instrument Uses Remaining) upon…
Thrombogenicity test results demonstrated that both the test devices (SSS) and control devices (OM) did not meet the internal specification of non-thrombogenic .
An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems.
An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems.
This page summarizes recall records in which the official source identifies Stryker Sustainability Solutions as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.