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 Jun 11, 2025
VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Luminex Corporation
FDA (openFDA device enforcement)
Reported Jun 11, 2025
Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2. CRANIOTOMY, SKU…
High riskUsing this product could cause serious injury, illness or death — stop using it now.MEDLINE INDUSTRIES, LP - Northfield
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 11, 2025
Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mozarc Medical US LLC
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 11, 2025
Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Jun 11, 2025
Signature Laparoscopic Instruments, Dolphin Nose Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Silex Medical, LLC
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 11, 2025
Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F
High riskUsing this product could cause serious injury, illness or death — stop using it now.SunMed Holdings, LLC
FDA (openFDA device enforcement)
Reported Jun 11, 2025
MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Virtual Incision Corporation
FDA (openFDA device enforcement)
Reported Jun 4, 2025
Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported Jun 4, 2025
Apo B Reagent, REF: OSR6143
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Beckman Coulter Ireland, Inc.
FDA (openFDA device enforcement)
Reported Jun 4, 2025
BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BioFire Diagnostics, LLC
FDA (openFDA device enforcement)
Reported Jun 4, 2025
Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.C-Rad Positioning Ab
FDA (openFDA device enforcement)
Reported Jun 4, 2025
Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 4, 2025
Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiopulmonary Ag
FDA (openFDA device enforcement)
Reported Jun 4, 2025
ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mckesson Medical-Surgical Inc. Corporate Office
31 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 4, 2025
NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.NxStage Medical Inc.
FDA (openFDA device enforcement)
Reported Jun 4, 2025
ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Onkos Surgical, Inc.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 4, 2025
VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Jun 4, 2025
Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Prismatik Dentalcraft, Inc.
FDA (openFDA device enforcement)
Reported Jun 4, 2025
DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Pro-Med Instruments GmbH
FDA (openFDA device enforcement)
Reported Jun 4, 2025
Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
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 Jun 4, 2025
Plus Initial Drill, Article Number: 103.170;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Straumann USA LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 4, 2025
Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ultra Clean Systems, Inc.
FDA (openFDA device enforcement)
Reported May 28, 2025
HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Advanced Bionics, LLC
FDA (openFDA device enforcement)
Reported May 28, 2025
Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
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.