Medical device recalls
Device recalls are the largest single group in this archive, because the FDA logs corrections and removals as well as outright withdrawals. Many are handled entirely between the manufacturer and a hospital and need nothing from a patient. Each notice states who has to act.
13,634 stored notices, reported between Jun 20, 2012 and Sep 9, 2026. Newest first.
Reported Mar 8, 2023
Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Summit Medical, LLC
FDA (openFDA device enforcement)
Reported Mar 8, 2023
MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Unetixs Vascular, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 8, 2023
ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wright Medical Technology, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 1, 2023
HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Access Vascular, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 1, 2023
Cardinal Health Presource Packs IV START KIT- Intended for IV access device CATALOG #: 01-5798B
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 1, 2023
NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L)
High riskUsing this product could cause serious injury, illness or death — stop using it now.Draeger Medical, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 1, 2023
Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hologic, Inc.
FDA (openFDA device enforcement)
Reported Mar 1, 2023
Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits per case, containing Ethicon Biopatch…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 1, 2023
abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF BC21087 abm Respiratory Care Standart…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.S & Mohr America, S.a. de C.v.
FDA (openFDA device enforcement)
Reported Mar 1, 2023
ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for the qualitative…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 1, 2023
Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 22, 2023
HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Access Vascular, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 22, 2023
iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Conformis, Inc.
FDA (openFDA device enforcement)
Reported Feb 22, 2023
Surgical convenience kits labeled as: MEDLINE PAIN TRAY, Reorder Number DYNJRA1122A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
19 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 22, 2023
EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MicroPort Orthopedics Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 22, 2023
EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Feb 22, 2023
Orthex Large Bone Shoulder Bolt, model no. AS-17
Moderate riskThis product could cause temporary or reversible health problems — stop using it.OrthoPediatrics Corp.
FDA (openFDA device enforcement)
Reported Feb 22, 2023
SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 15, 2023
The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bard Peripheral Vascular Inc.
FDA (openFDA device enforcement)
Reported Feb 15, 2023
GE Nuclear Medicine 600/800 series systems, specifically: a) 870, b) 870 DR 3/8 inch NM GANTRY WITH NEW ROTOR - MEA, c)…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Ge Medical Systems Israel, Functional Imaging
5 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 15, 2023
ANCILLARY PACK-LF. Sterile Procedural Tray.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
37 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 15, 2023
NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.NuVasive Inc.
FDA (openFDA device enforcement)
Reported Feb 15, 2023
SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Feb 15, 2023
FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Owens & Minor Distribution, Inc.
FDA (openFDA device enforcement)
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RecallNow is not a government agency. Every notice above was published by the FDA, USDA FSIS or CPSC and links back to its source. Browse the whole archive.