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 Apr 23, 2025
Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Channel Medsystems, Inc.
FDA (openFDA device enforcement)
Reported Apr 23, 2025
restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Conformis Inc.
FDA (openFDA device enforcement)
Reported Apr 23, 2025
Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 23, 2025
Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
FDA (openFDA device enforcement)
Reported Apr 23, 2025
Medline Convenience kits used for various procedures: 1) INTUBATION TRAY, Model Number: MNS10395;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
33 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 23, 2025
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Description: Rover Mobile…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Micro-X Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 23, 2025
Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 23, 2025
TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Straumann USA LLC
FDA (openFDA device enforcement)
Reported Apr 23, 2025
Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker GmbH
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 23, 2025
t:slim X2 Insulin Pump with Interoperable Technology
High riskUsing this product could cause serious injury, illness or death — stop using it now.Tandem Diabetes Care, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 23, 2025
HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Thoratec LLC
FDA (openFDA device enforcement)
Reported Apr 23, 2025
Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200…
High riskUsing this product could cause serious injury, illness or death — stop using it now.ZOLL Circulation, Inc.
FDA (openFDA device enforcement)
Reported Apr 16, 2025
GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required kit…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Agilent Technologies, Inc.
FDA (openFDA device enforcement)
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)
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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.