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 Jul 13, 2022
EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when used as an…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Spine, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 13, 2022
NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
FDA (openFDA device enforcement)
Reported Jul 13, 2022
GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical images and data…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
FDA (openFDA device enforcement)
Reported Jul 13, 2022
Verigene CDF Nucleic Acid Test, Part No. 30-002-22
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Luminex Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 13, 2022
CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Menarini Silicon Biosystems
FDA (openFDA device enforcement)
Reported Jul 13, 2022
OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ossur Americas
FDA (openFDA device enforcement)
Reported Jul 13, 2022
ABL800 Flex Analyzer Model Numbers 393-800 and 393-801
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Radiometer Medical ApS
FDA (openFDA device enforcement)
Reported Jul 13, 2022
RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Rayner Intraocular Lenses Ltd.
FDA (openFDA device enforcement)
Reported Jul 13, 2022
Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 13, 2022
syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as…
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 Jul 6, 2022
Arrow Three-Lumen CVC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ARROW INTERNATIONAL Inc.
FDA (openFDA device enforcement)
Reported Jul 6, 2022
Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Atrium Medical Corporation
FDA (openFDA device enforcement)
Reported Jul 6, 2022
#1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LED
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 6, 2022
Sensica Urine Output System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.C.R. Bard Inc.
FDA (openFDA device enforcement)
Reported Jul 6, 2022
System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Canon Medical System, USA, Inc.
FDA (openFDA device enforcement)
Reported Jul 6, 2022
DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Changzhou Biomet Medical Devices Co., Ltd.
FDA (openFDA device enforcement)
Reported Jul 6, 2022
ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.)
FDA (openFDA device enforcement)
Reported Jul 6, 2022
HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle only, with Cojoined Suction and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Davol, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 6, 2022
Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
FDA (openFDA device enforcement)
Reported Jul 6, 2022
Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 6, 2022
VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP ARD568811911 VLT600SF AIM STP…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Getinge USA Sales Inc.
FDA (openFDA device enforcement)
Reported Jul 6, 2022
Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Haemonetics Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 6, 2022
Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.K2M, Inc.
FDA (openFDA device enforcement)
Reported Jul 6, 2022
Medline Pill Splitters; 1 each/box; 144 boxes/carton
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
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.