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 May 8, 2024
Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
FDA (openFDA device enforcement)
Reported May 8, 2024
Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Noah Medical
FDA (openFDA device enforcement)
Reported May 8, 2024
POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 8, 2024
The Oncology Essentials Package of the Spectral CT imaging system.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
FDA (openFDA device enforcement)
Reported May 8, 2024
RayStation 7.0.0.19. Radiation Therapy Treatment Planning System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
11 more products in this recall
FDA (openFDA device enforcement)
Reported May 8, 2024
Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sedecal Sa
FDA (openFDA device enforcement)
Reported May 8, 2024
The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Neurovascular
FDA (openFDA device enforcement)
Reported May 8, 2024
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
High riskUsing this product could cause serious injury, illness or death — stop using it now.Thoratec Corp.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 8, 2024
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Sterile-…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
20 more products in this recall
FDA (openFDA device enforcement)
Reported May 1, 2024
3M Durapore Surgical Tape, Catalog Number 1538-118
Moderate riskThis product could cause temporary or reversible health problems — stop using it.3M Company - Health Care Business
FDA (openFDA device enforcement)
Reported May 1, 2024
Alinity m System, Part Number: 08N53-002
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Molecular, Inc.
FDA (openFDA device enforcement)
Reported May 1, 2024
Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissection Cannulas. These Custom…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Research, LLC
FDA (openFDA device enforcement)
Reported May 1, 2024
Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported May 1, 2024
VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b)…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Biomerieux Inc.
FDA (openFDA device enforcement)
Reported May 1, 2024
Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
FDA (openFDA device enforcement)
Reported May 1, 2024
Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LP
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 1, 2024
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ebi, LLC
3 more products in this recall
FDA (openFDA device enforcement)
Reported May 1, 2024
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Electro Medical Systems SA
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 1, 2024
TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
11 more products in this recall
FDA (openFDA device enforcement)
Reported May 1, 2024
IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ion Beam Applications S.A.
FDA (openFDA device enforcement)
Reported May 1, 2024
Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Leica Biosystems Nussloch GmbH
FDA (openFDA device enforcement)
Reported May 1, 2024
Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Parker Laboratories, Inc.
FDA (openFDA device enforcement)
Reported May 1, 2024
Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS): 1. APC (Schneider Electric IT…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
FDA (openFDA device enforcement)
Reported May 1, 2024
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Quidel Corporation
1 more product in this recall
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.