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 7, 2024
BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, 20 GA x 1.00 in (1.1x25 mm) 63…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson Infusion Therapy Systems, Inc.
FDA (openFDA device enforcement)
Reported Aug 7, 2024
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BioFire Diagnostics, LLC
FDA (openFDA device enforcement)
Reported Aug 7, 2024
Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner Package UPN: M0068318260. Capio…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 7, 2024
SlideView VS200 slide viewer,
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Evident Scientific Inc.
FDA (openFDA device enforcement)
Reported Aug 7, 2024
Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medivance Inc.
FDA (openFDA device enforcement)
Reported Aug 7, 2024
CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
FDA (openFDA device enforcement)
Reported Jul 31, 2024
Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Medical
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 31, 2024
MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Avanos Medical, Inc.
FDA (openFDA device enforcement)
Reported Jul 31, 2024
Brand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump System Model/Catalog Number: 8713030U Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B Braun Medical Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 31, 2024
Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Inc.
FDA (openFDA device enforcement)
Reported Jul 31, 2024
Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Jul 31, 2024
BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Counseling Sample Toolbox -Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Embecta Corp.
FDA (openFDA device enforcement)
Reported Jul 31, 2024
LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Link Bio Corp.
FDA (openFDA device enforcement)
Reported Jul 31, 2024
A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
FDA (openFDA device enforcement)
Reported Jul 31, 2024
TourniKwik Tourniquet Set (CFN 79012)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
FDA (openFDA device enforcement)
Reported Jul 31, 2024
NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Xomed, Inc.
FDA (openFDA device enforcement)
Reported Jul 31, 2024
ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Jul 31, 2024
ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Radiometer Medical ApS
FDA (openFDA device enforcement)
Reported Jul 31, 2024
RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Randox Laboratories Ltd.
FDA (openFDA device enforcement)
Reported Jul 31, 2024
Arial Call Station, Model Numbers CSK200 and CSK200MR, is a wireless, battery-operated call device installed inside…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Securitas Healthcare LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 31, 2024
Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -Intended to be used as a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 24, 2024
Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Medical
11 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 24, 2024
Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abiomed, Inc.
FDA (openFDA device enforcement)
Reported Jul 24, 2024
Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Research LLC
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.