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 12, 2024
OES 4000 Hysteroscope, Model/Catalog Number: A4674A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Jun 12, 2024
VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the…
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 Jun 12, 2024
HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 12, 2024
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Remote Diagnostic Technologies Ltd.
FDA (openFDA device enforcement)
Reported Jun 12, 2024
Arial mobile application, model numbers 54640, 54630, and 54630-SMA, that utilizes Apple iOS 17.4 and Apple iOS 17.5, a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Securitas Healthcare LLC
FDA (openFDA device enforcement)
Reported Jun 12, 2024
The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip. The outside diameter of the Synchro…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Neurovascular
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 12, 2024
Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product Description: Serialized Monitor
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Verathon, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 12, 2024
WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction Manual and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.WAVi Co.
FDA (openFDA device enforcement)
Reported Jun 5, 2024
Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStainer, CoverStainer CPO Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Agilent Technologies
FDA (openFDA device enforcement)
Reported Jun 5, 2024
20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Research LLC
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 5, 2024
Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Neuromodulation Corporation
FDA (openFDA device enforcement)
Reported Jun 5, 2024
BD Pyxis MedStation ES, REF: 323, Medication Cabinet
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 5, 2024
Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien, LP
FDA (openFDA device enforcement)
Reported Jun 5, 2024
FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.FUJIFILM Healthcare Americas Corporation
FDA (openFDA device enforcement)
Reported Jun 5, 2024
Brand Name: EsophaCap Product Name: EsophaCap (20mm diameter, 20 pores/inch) Model/Catalog Number: EC20T20VI Software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Lucid Diagnostics, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 5, 2024
Medline Sub-G Endotracheal Tube with Subglottic Suctioning: (1) REF DYNJ18860, Polyurethane Cuff 6.0 mm ID; (2) REF…
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 5, 2024
Captus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mirion Technologies (Capintec), Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 5, 2024
Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 5, 2024
RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Reflexion Medical, Inc.
FDA (openFDA device enforcement)
Reported Jun 5, 2024
smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew Inc.
FDA (openFDA device enforcement)
Reported Jun 5, 2024
Trevo XP ProVue Retriever 4 x 20, Catalog: 90182 Trevo XP ProVue Retriever 3 x 20, Catalog: 90183 Trevo XP ProVue…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Neurovascular
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 5, 2024
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Orthopaedics
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 5, 2024
STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
FDA (openFDA device enforcement)
Reported May 29, 2024
Cascade IOMAX Cortical Module, REF: 190296-200
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cadwell Industries 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.