Medical DeviceMay 11, 2022
Baxter Healthcare Flo-Thru Intraluminal Shunt recall — FDA Z-1019-2022
There is a potential for foreign matter.
Class IIFDA: TerminatedBaxter Healthcare Corporation
24,239medical device recall records
2,205FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.751 records
Database records
Records — page 436
24,239 detailed records are currently available in this category.
Medical DeviceMay 11, 2022
Siemens Healthcare Diagnostics ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro recall — FDA Z-1024-2022
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Medical DeviceMay 11, 2022
Johnson & Johnson Surgical Vision TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING recall — FDA Z-1033-2022
Potential breach in the sterility barrier for tray ring covers.
Class IIFDA: OngoingJohnson & Johnson Surgical Vision Inc.
Medical DeviceMay 11, 2022
Siemens Healthcare Diagnostics ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro recall — FDA Z-1025-2022
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Medical DeviceMay 11, 2022
restor3d Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018) recall — FDA Z-1027-2022
During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.
Class IIFDA: Terminatedrestor3d Inc.
Medical DeviceMay 11, 2022
Siemens Healthcare Diagnostics Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro recall — FDA Z-1022-2022
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Medical DeviceMay 11, 2022
Becton Dickinson & Co BD Synapsys Microbiology Informatics Solution, Catalog Number 444150 recall — FDA Z-1018-2022
When updating BD Kiestra customers to BD Synapsys version 4.10, the custom antibiotic codes set by the customer are overwritten with the BD default antibiotic codes.
Class IIFDA: TerminatedBecton Dickinson & Co.
Medical DeviceMay 11, 2022
DePuy Orthopaedics VELYS Robotic-Assisted Solution Base Product No.: 451570100 recall — FDA Z-1029-2022
System software v1.5.1 has a system software issue related to the Daylight Savings Time (DST) change that can cause a system error, requiring the user to restart the system and potentially…
Class IIFDA: TerminatedDePuy Orthopaedics, Inc.
Medical DeviceMay 11, 2022
restor3d Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the recall — FDA Z-1026-2022
Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.
Class IIFDA: Terminatedrestor3d Inc.
Medical DeviceMay 11, 2022
restor3d Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness recall — FDA Z-1028-2022
During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.
Class IIFDA: Terminatedrestor3d Inc.
Medical DeviceMay 11, 2022
Siemens Healthcare Diagnostics Atellica IM Enhanced Estradiol (eE2) 500T - In vitro recall — FDA Z-1021-2022
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Medical DeviceMay 11, 2022
SML Distribution Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) recall — FDA Z-0944-2022
The product was distributed without FDA authorization or clearance for marketing and distribution in the US.
Class IFDA: OngoingSML Distribution, LLC
Medical DeviceMay 11, 2022
Siemens Healthcare Diagnostics ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro recall — FDA Z-1023-2022
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Medical DeviceMay 11, 2022
Siemens Healthcare Diagnostics Atellica IM Enhanced Estradiol (eE2) 100T - In vitro recall — FDA Z-1020-2022
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Medical DeviceMay 11, 2022
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V Azurion systems with software release R1.x recall — FDA Z-0886-2022
In the Azurion system, the user can add a new study to a patient by selecting the option Add Study . The Add Study dialogue box is then displayed where the Patient Type is selected to…
Class IIFDA: OngoingPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Medical DeviceMay 4, 2022
Intuitive Surgical da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi recall — FDA Z-0999-2022
As a result of complaint data review, it identified tissue pushout events occurring during firing of the SureForm stapler when tissue is pushed distally within the jaws, rather than being…
Class IIFDA: OngoingIntuitive Surgical, Inc.
Medical DeviceMay 4, 2022
Freudenberg Medical Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model recall — FDA Z-1016-2022
Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia
Class IIFDA: TerminatedFreudenberg Medical, LLC
Medical DeviceMay 4, 2022
Boston Scientific SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101 recall — FDA Z-1002-2022
Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that…
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMay 4, 2022
Siemens Medical Solutions USA Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only recall — FDA Z-1010-2022
Transducers (component of ultrasound system) may exceed recommended thermal index limits
Class IIFDA: OngoingSiemens Medical Solutions USA, Inc.
Medical DeviceMay 4, 2022
Boston Scientific SpaceOAR Vue System, UPN SV-1010 and SV-2101 recall — FDA Z-1003-2022
Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that…
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMay 4, 2022
Stryker GmbH Smart Toe II Intramedullary Arthrodesis Implant recall — FDA Z-1011-2022
The nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing "Indicated for patients with Nickel sensitivity" instead of "Not…
Class IIFDA: OngoingStryker GmbH
Medical DeviceMay 4, 2022
ROi CPS Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging recall — FDA Z-1005-2022
A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
Class IIFDA: TerminatedROi CPS LLC
Medical DeviceMay 4, 2022
Draegar Medical Systems Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 recall — FDA Z-1012-2022
Software issue resulting in temporary loss of central monitoring functionality.
Class IIFDA: OngoingDraegar Medical Systems, Inc.
Medical DeviceMay 4, 2022
Siemens Healthcare Diagnostics IMMULITE 2000 Systems HCG [200 Tests, material number recall — FDA Z-1015-2022
Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors.
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
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.