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 Feb 15, 2023
Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Quest Medical, Inc.
FDA (openFDA device enforcement)
Reported Feb 15, 2023
cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Molecular Systems, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 15, 2023
HIGH V+ Spinal Cement System REF T040321K
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teknimed Sas
FDA (openFDA device enforcement)
Reported Feb 15, 2023
TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular Instrument…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Trackx Technology Inc.
FDA (openFDA device enforcement)
Reported Feb 15, 2023
RipCord Syndesmosis Button, REF: STA001K
Moderate riskThis product could cause temporary or reversible health problems — stop using it.TriMed Inc.
FDA (openFDA device enforcement)
Reported Feb 15, 2023
WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part Number XXS…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wishbone Medical, Inc.
FDA (openFDA device enforcement)
Reported Feb 15, 2023
Identity Shoulder System Resection Planer 35mm Resection Planer
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
FDA (openFDA device enforcement)
Reported Feb 8, 2023
Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair Kit 0601610 4.2 Fr Broviac CV Catheter…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bard Peripheral Vascular Inc.
FDA (openFDA device enforcement)
Reported Feb 8, 2023
OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 8, 2023
Mammotome MammoStar Biopsy Site Identified, REF STAR1401
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carbon Medical Technologies, Inc.
FDA (openFDA device enforcement)
Reported Feb 8, 2023
BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CooperSurgical, Inc.
FDA (openFDA device enforcement)
Reported Feb 8, 2023
Non-sterile procedural trays labeled as CRANI, 2 per case
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
9 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 8, 2023
AxiEM" Non-Invasive Patient Tracker
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
FDA (openFDA device enforcement)
Reported Feb 8, 2023
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
5 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 8, 2023
Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.NovaSignal Corp.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 8, 2023
System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Feb 8, 2023
CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 8, 2023
SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.SynCardia Systems LLC
FDA (openFDA device enforcement)
Reported Feb 8, 2023
Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Turbett Surgical, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 8, 2023
Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Universal Meditech Inc.
FDA (openFDA device enforcement)
Reported Feb 8, 2023
GORE CARDIOFORM Septal Occluder, REF: GSX0030A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.W L Gore & Associates, Inc.
FDA (openFDA device enforcement)
Reported Feb 1, 2023
Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Molecular, Inc.
FDA (openFDA device enforcement)
Reported Feb 1, 2023
Agfa HealthCare Enterprise Imaging XERO Viewer
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Agfa Healthcare NV
FDA (openFDA device enforcement)
Reported Feb 1, 2023
Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Align Technology 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.