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 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)
Reported Apr 2, 2025
Baxter Operating table column TS7500 MOBIUS, Product Code 1704695
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
15 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 2, 2025
CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Calyxo, Inc.
FDA (openFDA device enforcement)
Reported Apr 2, 2025
Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Small…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Checkpoint Surgical Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 2, 2025
Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigmatism, Pearle Vision 1…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CooperVision, Inc.
FDA (openFDA device enforcement)
Reported Apr 2, 2025
Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
High riskUsing this product could cause serious injury, illness or death — stop using it now.Covidien
FDA (openFDA device enforcement)
Reported Apr 2, 2025
namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
28 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 2, 2025
Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
FDA (openFDA device enforcement)
Reported Apr 2, 2025
Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microbiologics Inc.
FDA (openFDA device enforcement)
Reported Apr 2, 2025
Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Orthofix U.S. LLC
FDA (openFDA device enforcement)
Reported Apr 2, 2025
Premier Solo Diamond - Large Invented Cone; SKU: 807016C.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Premier Dental Products Co.
FDA (openFDA device enforcement)
Reported Apr 2, 2025
CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.St. Jude Medical
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.