Search U.S. Product Recalls Database

Showing 5521–5540 of 8393 results

Sort:

Hoffmann LRF Transport Strut (Stryker) – Thread Pitch Issue (2023)

Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone Transport Struts. Specifically, the thread pitch is oversized at the distal end of the threaded rod, and as a result the distal ring fixation cannot be locked between 0- 50mm of the threaded rod.

Moderate

FDAFeb 7, 2023Nationwide• Stryker GmbH Bohnackerweg 1 Selzach Switzerland

CardioMEMS HF System (St. Jude) – RF Emissions Issue (2023)

Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000 exceed certain emissions limits and have the potential to cause interference with other medical devices, such as implantable neurostimulators, pacemakers, cardiac defibrillators, continuous glucose monitors, or other bio-wearable sensors when in close proximity to an active Hospital or Patient Electronics System (i.e., during readings).

Moderate

Stay Informed

Search Product Recalls

Hoffmann LRF Transport Strut (Stryker) – Thread Pitch Issue (2023)

CardioMEMS HF System (St. Jude) – RF Emissions Issue (2023)

CardioMEMS HF System (St. Jude) – Sensor Reading Concern (2023)

Cardiosave Rescue (Datascope) – Helium Tank Leak Risk (2023)

Cardiosave Rescue IABP (Datascope) – Unexpected Shutdown Risk (2023)

Cardiosave Hybrid IABP (Datascope) – Unexpected Shutdown Risk (2023)

Cardiosave Rescue (Datascope) – Communication Failure Issue (2023)

CardioMEMS HF System (St. Jude) – RF Emissions Issue (2023)

injeTAK Needles (Labories) – Packaging Damage Concern (2023)

Cardiosave Hybrid IABP (Datascope) – Helium Regulator Failure (2023)

Cardiosave Hybrid IABP (Datascope) – Helium Tank Leak Risk (2023)

Cardiosave Hybrid (Datascope) – Communication Failure Issue (2023)

MYLA AST Filters (Biomerieux) – Test Definition Issue (2023)

G7 Acetabular System (Biomet) – Liner Mislabeling Problem (2023)

Phoenix mKDR Xpress (Sedecal) – X-Ray Movement Problem (2023)

Arial Mobile App (Securitas) – Loading Malfunction (2023)

Phoenix mKDR (Sedecal) – X-Ray Movement Concern (2023)

ACL ELITE PRO-Analyzer (Instrumentation Laboratory) – Test Definition Removal (2023)

Med-Riser Patient Lift (Med-Mizer) – Boom Pivot Failure (2023)

ACL ELITE PRO Analyzer (Instrumentation) – Test Definition Removal (2023)