Medical DeviceJan 28, 2026
MicroPort HIPTURN FEM HEAD TRIAL 36MM REUSABLE recall — FDA Z-1133-2026
Due to products not having FDA Premarket authorization to be distributed within the United States.
Class IIFDA: OngoingMicroPort Orthopedics Inc.
1,647medical device recall records
246FDA Class I records
8firms with 5+ records
Medline Industries, LP403 records
Database records
Records — page 62
1,647 detailed records are currently available in this category.
Medical DeviceJan 28, 2026
Merit Medical Systems Allwell Angioplasty Pack REF: IS-30-B1/B recall — FDA Z-1129-2026
Inflation device handle may detach from the syringe during procedure.
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceJan 28, 2026
EDAN Central Monitoring System recall — FDA Z-1150-2026
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Class IIFDA: OngoingEdan Diagnostics
Medical DeviceJan 28, 2026
Philips Patient Information Center iX recall — FDA Z-1156-2026
A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system.
Class IIFDA: OngoingPhilips North America
Medical DeviceJan 28, 2026
EDAN Patient Monitor recall — FDA Z-1148-2026
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Class IIFDA: OngoingEdan Diagnostics
Medical DeviceJan 28, 2026
VOLT" Wrist Treatment System 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm recall — FDA Z-1131-2026
The supplier manufactured anatomical left plates with an incorrect thread orientation.
Class IIFDA: OngoingTyber Medical
Medical DeviceJan 28, 2026
Mazor X robotic guidance system REF: TPL0059 recall — FDA Z-1122-2026
Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
Class IIFDA: OngoingMazor Robotics Ltd
Medical DeviceJan 28, 2026
Beckman Coulter Ireland The LDL-Cholesterol assay is comprised of two distinct phases recall — FDA Z-1135-2026
Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use (IFU). LDL Cholesterol reagent showed clinically significant…
Class IIFDA: OngoingBeckman Coulter Ireland, Inc.
Medical DeviceJan 28, 2026
Ion Endoluminal System Ion Vision Probe Bag recall — FDA Z-1134-2026
Due to probe bags that may have a compromised or incomplete sterile pouch seal.
Class IIFDA: OngoingIntuitive Surgical, Inc.
Medical DeviceJan 28, 2026
RAYSEARCH LABORATORIES AB RayStation/RayPlan recall — FDA Z-1102-2026
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and…
Class IIFDA: OngoingRAYSEARCH LABORATORIES AB
Medical DeviceJan 28, 2026
EDAN Fetal & Maternal Monitor recall — FDA Z-1141-2026
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Class IIFDA: OngoingEdan Diagnostics
Medical DeviceJan 28, 2026
Community Products Rifton Equipment, Low Base TRAM recall — FDA Z-1138-2026
Potential for fraying on the body support strap.
Class IIFDA: OngoingCommunity Products, LLC
Medical DeviceJan 28, 2026
EDAN Patient Monitor recall — FDA Z-1145-2026
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Class IIFDA: OngoingEdan Diagnostics
Medical DeviceJan 28, 2026
MEDLINE beds labeled as: 1) Semi Electric Basic Homecare Bed, REF MDR107002E recall — FDA Z-1011-2026
Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its specified…
Class IFDA: OngoingMedline Industries, LP
Medical DeviceJan 28, 2026
EDAN Patient Monitor recall — FDA Z-1147-2026
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Class IIFDA: OngoingEdan Diagnostics
Medical DeviceJan 28, 2026
GVS TM SQ40S Blood Transfusion Filter recall — FDA Z-1157-2026
Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.
Class IIFDA: OngoingGVS TM, Inc.
Medical DeviceJan 21, 2026
Elekta MOSAIQ Oncology Information System with Particle Therapy License recall — FDA Z-1078-2026
Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field…
Class IIFDA: OngoingElekta, Inc.
Medical DeviceJan 21, 2026
Canon Medical System, USA VANTAGE GALAN 3T Model MRT-3020/MEXL-3020 recall — FDA Z-1017-2026
There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able…
Class IIFDA: OngoingCanon Medical System, USA, Inc.
Medical DeviceJan 21, 2026
Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF recall — FDA Z-1090-2026
Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of…
Class IIFDA: OngoingMedline Industries, LP
Medical DeviceJan 21, 2026
Intuitive Surgical da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 recall — FDA Z-1096-2026
Access Port System tray may develop cracks potentially resulting in a sterility breach.
Class IIFDA: OngoingIntuitive Surgical, Inc.
Medical DeviceJan 21, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V Allura Xper FD10F recall — FDA Z-1063-2026
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the…
Class IIFDA: OngoingPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Medical DeviceJan 21, 2026
Medline Kits containing B recall — FDA Z-1054-2026
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck…
Class IIFDA: OngoingMedline Industries, LP
Medical DeviceJan 21, 2026
PALACOS R+G pro 40; PALACOS R+G pro 80 recall — FDA Z-1081-2026
increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage.…
Class IIFDA: OngoingHeraeus Medical GmbH (Dental Division)
Medical DeviceJan 21, 2026
Medtronic Neuromodulation A71200 Vanta" Clinician Programmer Application (CP App) version recall — FDA Z-1043-2026
Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.
Class IIFDA: OngoingMedtronic Neuromodulation
How to use this medical device recall index
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
What the database can and cannot tell you
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.