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 Oct 11, 2023
Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
FDA (openFDA device enforcement)
Reported Oct 11, 2023
Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
FDA (openFDA device enforcement)
Reported Oct 11, 2023
Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiN…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
5 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 11, 2023
Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Oct 11, 2023
Incisive CT, software version 5.0
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Healthcare
FDA (openFDA device enforcement)
Reported Oct 11, 2023
EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa)…
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 Oct 11, 2023
therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Qiagen GmbH
FDA (openFDA device enforcement)
Reported Oct 11, 2023
GS0008 2Y - Burn Pack - STL, Item Number 880082025
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
FDA (openFDA device enforcement)
Reported Oct 11, 2023
ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Oct 11, 2023
(1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Oct 11, 2023
Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Thoratec Corp.
FDA (openFDA device enforcement)
Reported Oct 11, 2023
Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the dermatome handpiece which is a skin…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Surgical Inc.
FDA (openFDA device enforcement)
Reported Oct 4, 2023
3M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualify or monitor dynamic-air-removal steam…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.3M Company - Health Care Business
3 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 4, 2023
Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ambu Inc.
FDA (openFDA device enforcement)
Reported Oct 4, 2023
B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 4, 2023
Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported Oct 4, 2023
BD Pyxis MedBank MedPass Software, REF: 139088-01
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
FDA (openFDA device enforcement)
Reported Oct 4, 2023
Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LP
FDA (openFDA device enforcement)
Reported Oct 4, 2023
exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exocad GmbH
FDA (openFDA device enforcement)
Reported Oct 4, 2023
Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Kabi USA, LLC
FDA (openFDA device enforcement)
Reported Oct 4, 2023
Various Medical Products stored on pallets, including but not limited to bandages, tampons, condoms, blood glucose…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Inmar Supply Chain Solutions, LLC
FDA (openFDA device enforcement)
Reported Oct 4, 2023
ProSun International Luxura Vegaz, Model 52X; Ultraviolet Tanning Device
Moderate riskThis product could cause temporary or reversible health problems — stop using it.J&T Health and Wellness LLC
FDA (openFDA device enforcement)
Reported Oct 4, 2023
Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Philips Respironics, Inc.
FDA (openFDA device enforcement)
Reported Oct 4, 2023
Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker 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.