Class IIOngoingZ-1139-2026
Community Products, LLC recalls Rifton Equipment
Potential for fraying on the body support strap.
Community Products, LL…NYJan 28, 2026
Class II recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1,309–1,320 of 3,866 recalls
Class IIOngoingZ-1138-2026
Community Products, LLC recalls Rifton Equipment
Potential for fraying on the body support strap.
Community Products, LL…NYJan 28, 2026
Class IIOngoingZ-1137-2026
Community Products, LLC recalls Rifton Equipment
Potential for fraying on the body support strap.
Community Products, LL…NYJan 28, 2026
Class IIOngoingZ-1136-2026
Sysmex America, Inc. recalls TS-10/TS-10H Tube Sorter
Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift.
Sysmex America, Inc.ILJan 28, 2026
Class IIOngoingZ-1135-2026
Beckman Coulter Ireland, Inc. recalls The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique de…
Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use (IFU).…
Beckman Coulter Irelan…Jan 28, 2026
Class IIOngoingZ-1134-2026
Intuitive Surgical, Inc. recalls Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog N…
Due to probe bags that may have a compromised or incomplete sterile pouch seal.
Intuitive Surgical, In…CAJan 28, 2026
Class IIOngoingZ-1133-2026
MicroPort Orthopedics Inc. recalls Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalo…
Due to products not having FDA Premarket authorization to be distributed within the United States.
MicroPort Orthopedics…TNJan 28, 2026
Class IIOngoingZ-1132-2026
Tyber Medical recalls Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Pla…
The supplier manufactured anatomical left plates with an incorrect thread orientation.
Tyber MedicalPAJan 28, 2026
Class IIOngoingZ-1131-2026
Tyber Medical recalls Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Pla…
The supplier manufactured anatomical left plates with an incorrect thread orientation.
Tyber MedicalPAJan 28, 2026
Class IICompletedZ-1130-2026
LEASEIR TECHNOLOGIES SLU recalls Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b…
The console label for affected devices is missing the "DANGER" symbol.
LEASEIR TECHNOLOGIES S…Jan 28, 2026
Class IIOngoingZ-1129-2026
Merit Medical Systems, Inc. recalls Allwell Angioplasty Pack REF: IS-30-B1/B
Inflation device handle may detach from the syringe during procedure.
Merit Medical Systems,…UTJan 28, 2026
Class IIOngoingZ-1128-2026
Merit Medical Systems, Inc. recalls Merit Medical
Inflation device handle may detach from the syringe during procedure.
Merit Medical Systems,…UTJan 28, 2026