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 24, 2024
Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Masimo Corporation
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 24, 2024
Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
High riskUsing this product could cause serious injury, illness or death — stop using it now.Outset Medical, Inc.
FDA (openFDA device enforcement)
Reported Apr 24, 2024
Achieva 1.5T, Magnetic Resonance System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
40 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 24, 2024
Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
High riskUsing this product could cause serious injury, illness or death — stop using it now.Philips Respironics, Inc.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 24, 2024
Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Randox Laboratories Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 24, 2024
SW Bari Lift & Transfer, Model Number 38060000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raye's Inc.
FDA (openFDA device enforcement)
Reported Apr 24, 2024
Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Apr 24, 2024
Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling-…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Apr 24, 2024
RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew Medical, Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 24, 2024
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 24, 2024
AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
High riskUsing this product could cause serious injury, illness or death — stop using it now.SonarMed Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 24, 2024
POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Surgical Specialties
FDA (openFDA device enforcement)
Reported Apr 24, 2024
Neria Soft Infusion Set, Product Code 507302, intravascular administration set
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Unomedical A/S
FDA (openFDA device enforcement)
Reported Apr 17, 2024
Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models: a) PROBP…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 17, 2024
EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
4 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 17, 2024
ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ConvaTec, Inc.
FDA (openFDA device enforcement)
Reported Apr 17, 2024
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
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 17, 2024
Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/o Hanger Bar, REF: 55300H-NA, patient…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Human Care Hc Sweden Ab
FDA (openFDA device enforcement)
Reported Apr 17, 2024
Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
FDA (openFDA device enforcement)
Reported Apr 17, 2024
Bed Assist Bars, labeled as follows: a) Medline, Model Number BA6800, b) Medline Martha Stewart, Model Number…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 17, 2024
KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microbiologics Inc.
FDA (openFDA device enforcement)
Reported Apr 17, 2024
Hemostasis Probe, Model: CD-B622LA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Apr 17, 2024
PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
FDA (openFDA device enforcement)
Reported Apr 17, 2024
EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Qiagen Sciences LLC
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.