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 Nov 20, 2024
Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 20, 2024
Philips Zenition 50, Model Number: 718096
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 20, 2024
Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Philips Respironics, Inc.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 20, 2024
IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Nov 20, 2024
Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed for general electrosurgical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
5 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 20, 2024
VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-use pouch made of plastic intended to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Metrix Company
15 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 20, 2024
The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Topcon Medical Systems, Inc.
FDA (openFDA device enforcement)
Reported Nov 20, 2024
SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wissner-Bosserhoff GmbH
FDA (openFDA device enforcement)
Reported Nov 13, 2024
Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Surgical Company, LLC
FDA (openFDA device enforcement)
Reported Nov 13, 2024
Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
6 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 13, 2024
The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Nov 13, 2024
intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biocare Medical, LLC
FDA (openFDA device enforcement)
Reported Nov 13, 2024
Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Canon Medical System, USA, Inc.
FDA (openFDA device enforcement)
Reported Nov 13, 2024
MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Datascope Corp.
FDA (openFDA device enforcement)
Reported Nov 13, 2024
DeRoyal C-SECTION TRACEPACK, REF 89-9338-06
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DeRoyal Industries Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 13, 2024
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Elekta Instrument AB
FDA (openFDA device enforcement)
Reported Nov 13, 2024
Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
FDA (openFDA device enforcement)
Reported Nov 13, 2024
GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2089507-083, GDZH-JINWAN-Centricity 2)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
FDA (openFDA device enforcement)
Reported Nov 13, 2024
iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Iotamotion Inc.
FDA (openFDA device enforcement)
Reported Nov 13, 2024
Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
FDA (openFDA device enforcement)
Reported Nov 13, 2024
Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxygen,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nihon Kohden America Inc.
FDA (openFDA device enforcement)
Reported Nov 13, 2024
SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Shimadzu Corporation Medical Systems Division
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 13, 2024
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics Inc.
FDA (openFDA device enforcement)
Reported Nov 13, 2024
Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, 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.