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 19, 2023
Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Edwards Lifesciences, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 19, 2023
EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Encore Medical, LP
FDA (openFDA device enforcement)
Reported Apr 19, 2023
Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
FDA (openFDA device enforcement)
Reported Apr 19, 2023
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 19, 2023
Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
FDA (openFDA device enforcement)
Reported Apr 19, 2023
Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Outset Medical, Inc.
FDA (openFDA device enforcement)
Reported Apr 19, 2023
CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 19, 2023
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Shanghai United Imaging Healthcare Co., Ltd.
FDA (openFDA device enforcement)
Reported Apr 19, 2023
thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF GENERATOR REF TG-2B *** Solta Medical, Inc.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Solta Medical Inc.
FDA (openFDA device enforcement)
Reported Apr 19, 2023
Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only) ROC-9840, Roberts Oxygen Ready to Use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Western/Scott Fetzer Company
FDA (openFDA device enforcement)
Reported Apr 12, 2023
FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash Glucose Monitoring…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abbott Diabetes Care, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 12, 2023
Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Molecular, Inc.
FDA (openFDA device enforcement)
Reported Apr 12, 2023
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biosense Webster, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 12, 2023
Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CooperSurgical, Inc.
FDA (openFDA device enforcement)
Reported Apr 12, 2023
VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 12, 2023
Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102; c)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
11 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 12, 2023
Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitoring system that…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Moberg Research, Inc.
FDA (openFDA device enforcement)
Reported Apr 12, 2023
Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Philips Respironics, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 12, 2023
Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Remote Diagnostic Technologies Ltd.
FDA (openFDA device enforcement)
Reported Apr 12, 2023
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS…
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 Apr 12, 2023
CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 5, 2023
Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Research, LLC
FDA (openFDA device enforcement)
Reported Apr 5, 2023
Atrium Pneumostat Chest Drain Valve, Part Number 16100
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Atrium Medical Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 5, 2023
Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
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.