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.
13,791 stored notices, reported between Jun 20, 2012 and Oct 28, 2026. Newest first.
Reported Aug 28, 2024
Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ventana Medical Systems, Inc.
FDA (openFDA device enforcement)
Reported Aug 21, 2024
L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Argon Medical Devices, Inc.
FDA (openFDA device enforcement)
Reported Aug 21, 2024
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 21, 2024
BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
FDA (openFDA device enforcement)
Reported Aug 21, 2024
BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biointellisense Inc.
FDA (openFDA device enforcement)
Reported Aug 21, 2024
WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Neuromodulation Corporation
FDA (openFDA device enforcement)
Reported Aug 21, 2024
Cepheid, Sample Collection Device, Part: 900-0370
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cepheid
FDA (openFDA device enforcement)
Reported Aug 21, 2024
RMU-2000 Automated Chest Compression Device
High riskUsing this product could cause serious injury, illness or death — stop using it now.Defibtech, LLC
FDA (openFDA device enforcement)
Reported Aug 21, 2024
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DKK Dai-Ichi Shomei Co., Ltd.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 21, 2024
Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.DRG International, Inc.
FDA (openFDA device enforcement)
Reported Aug 21, 2024
Brand Name: UNclog Eye Mask Product Name: UNclog Eye Mask Model/Catalog Number: AG23JW24 Serial # ag22 Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Eye Comfort Care LLC
FDA (openFDA device enforcement)
Reported Aug 21, 2024
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description…
High riskUsing this product could cause serious injury, illness or death — stop using it now.ICU Medical Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 21, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rapid…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
22 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 21, 2024
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Aug 21, 2024
Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray images…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Palodex Group Oy
FDA (openFDA device enforcement)
Reported Aug 21, 2024
HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Thoratec LLC
FDA (openFDA device enforcement)
Reported Aug 14, 2024
American Contract Systems Hand Pack convenience kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Contract Systems, Inc.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 14, 2024
CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Artivion, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 14, 2024
Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300
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 Aug 14, 2024
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BioFire Diagnostics, LLC
FDA (openFDA device enforcement)
Reported Aug 14, 2024
BD PYXIS MEDBANK MINI CR-2HH-1FH-P, REF: 169-114 containing software version 3.9.1.9
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
18 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 14, 2024
Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560 VENTILATOR/4096600, PURITAN BENNETT PB560…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Covidien
FDA (openFDA device enforcement)
Reported Aug 14, 2024
SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28.0 to DV28.5, DV29.0, DV29.1,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
25 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 14, 2024
TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
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.