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 Aug 2, 2023
Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits Ho:YAG laser energy from…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
6 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 2, 2023
YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provide counter pulsation therapy in the aorta.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Datascope Corp.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 2, 2023
Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Davol, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 2, 2023
HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults and…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Hamilton Medical, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 2, 2023
DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
FDA (openFDA device enforcement)
Reported Aug 2, 2023
A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
FDA (openFDA device enforcement)
Reported Aug 2, 2023
FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microvention Inc.
FDA (openFDA device enforcement)
Reported Aug 2, 2023
VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Ortho-Clinical Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Aug 2, 2023
QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Qiagen GmbH
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 2, 2023
Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Aug 2, 2023
Trexo Device
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Trexo Robotics Holdings Inc.
FDA (openFDA device enforcement)
Reported Aug 2, 2023
vRad PACS with Mammography
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Virtual Radiologic Corp.
FDA (openFDA device enforcement)
Reported Jul 26, 2023
Impella 2.5 intravascular micro axial blood pump, Product Number 005042
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abiomed, Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 26, 2023
Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Implant Systems LLC
FDA (openFDA device enforcement)
Reported Jul 26, 2023
Contour¿ next GEN Blood Glucose Monitoring System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ascensia Diabetes Care US, Inc.
FDA (openFDA device enforcement)
Reported Jul 26, 2023
GEM FLOW COUPLER Monitor, PN 5156-00000-011
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported Jul 26, 2023
Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Biomedical GmbH
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 26, 2023
Aeris Balloon Dilation Catheter
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bryan Medical Inc.
FDA (openFDA device enforcement)
Reported Jul 26, 2023
NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
FDA (openFDA device enforcement)
Reported Jul 26, 2023
RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cytocell Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 26, 2023
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Datascope Corp.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 26, 2023
Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DiaSorin Molecular LLC
FDA (openFDA device enforcement)
Reported Jul 26, 2023
Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Digisonics, Inc.
FDA (openFDA device enforcement)
Reported Jul 26, 2023
MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Materialise N.V.
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.