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 Apr 16, 2025
DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Apr 16, 2025
FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BioFire Diagnostics, LLC
FDA (openFDA device enforcement)
Reported Apr 16, 2025
BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 16, 2025
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.MEDLINE INDUSTRIES, LP - Northfield
10 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 16, 2025
Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
FDA (openFDA device enforcement)
Reported Apr 16, 2025
IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Omnicell, Inc.
FDA (openFDA device enforcement)
Reported Apr 16, 2025
Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF: APT6072-132. Hippo 072…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Qapel Medical Inc.
FDA (openFDA device enforcement)
Reported Apr 16, 2025
Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Apr 16, 2025
stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog Number MRUE200, packaged in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tornier S.A.S.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 9, 2025
BD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Connecta¿ Plus 1 and Connecta¿ Plus 3 2-way and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bd Switzerland Sarl
FDA (openFDA device enforcement)
Reported Apr 9, 2025
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Inc.
FDA (openFDA device enforcement)
Reported Apr 9, 2025
Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cordis US Corp.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 9, 2025
Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Draeger, Inc.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 9, 2025
PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon Endo Surgery, LLC
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 9, 2025
Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fisher Diagnostics
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 9, 2025
GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; 2) 2066908-136; 3) 2066908-150; 4)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
4 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 9, 2025
A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
FDA (openFDA device enforcement)
Reported Apr 9, 2025
Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Pyrames Inc.
FDA (openFDA device enforcement)
Reported Apr 9, 2025
Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Qiagen Sciences LLC
FDA (openFDA device enforcement)
Reported Apr 9, 2025
Phoroptor VRx Digital Refraction System Model Numbers: 16241
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Reichert, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 9, 2025
Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
13 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 9, 2025
Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Spine
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 9, 2025
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
FDA (openFDA device enforcement)
Reported Apr 2, 2025
Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Contract Systems, Inc.
2 more products 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.