Stryker Sustainability Solutions

4 FDA enforcement actions

4 Total Recalls

0 Class I

4 Class II

0 Class III

Firm Details

Product Types: device
States: AZ

All Recalls

Class II: Risk 09/24/2025 device

Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.
Class II: Risk 07/02/2024 device

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 not approved for reprocessing, but that may have been reprocessed, which may lead to devices not performing as intended.
Class II: Risk 05/31/2024 device

Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder.
Class II: Risk 05/10/2024 device

Diagnostic electrophysiology (EP) catheters do not meet testing requirements.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.