All recall categories

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.

Medical devices

Reported Mar 27, 2024

Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intubation to establish an airway in an…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Sarnova HC, LLC

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Mar 27, 2024

DCA Systems HbA1c Reagent Kit

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Siemens Healthcare Diagnostics, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Mar 27, 2024

smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Smiths Medical ASD Inc.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Mar 27, 2024

Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Think Surgical, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Mar 27, 2024

impression coping, repositionable, short, screw-retained, PF 4.0

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Thommen Medical AG

FDA (openFDA device enforcement)

Medical devices

Reported Mar 27, 2024

HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2.…

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Thoratec Corp.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Mar 20, 2024

STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Baxter Healthcare Corporation

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Mar 20, 2024

BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irrigation of the eye Catalog Number:…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Beaver Visitec International, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Mar 20, 2024

CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Biosense Webster, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Mar 20, 2024

LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Fresenius Kabi USA, LLC

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Mar 20, 2024

CVS Health Waterproof Wound Tracking Dressing, REF CVS690330, immediate package contains 1 sterile dressing, 4 in. x 4…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

MEDLINE INDUSTRIES, LP - Northfield

FDA (openFDA device enforcement)

Medical devices

Reported Mar 20, 2024

CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter,…

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Medos International Sarl

FDA (openFDA device enforcement)

Medical devices

Reported Mar 20, 2024

D-Clip Standard/Mini Applier, 190mm bayonet, jaw rigid, double action.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Peter Lazic GmbH

4 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Mar 20, 2024

EasyPoint Needle, 25G x 5/8", REF: 82091

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Retractable Technologies, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Mar 20, 2024

Shimadzu, Trinias, Digital Angiography System

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Shimadzu Corporation Medical Systems Division

FDA (openFDA device enforcement)

Medical devices

Reported Mar 20, 2024

Atellica IM Erythropoietin (EPO) Assay (100 Test)

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Siemens Healthcare Diagnostics, Inc.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Mar 20, 2024

SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Waldemar Link GmbH & Co. KG (Mfg Site)

3 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Mar 13, 2024

DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Aesculap Inc.

4 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Mar 13, 2024

MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector…

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Avanos Medical, Inc.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Mar 13, 2024

MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Canon Medical System, USA, Inc.

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Mar 13, 2024

BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352;

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

CareFusion 303, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Mar 13, 2024

ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

ConvaTec, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Mar 13, 2024

Synapse PACS - Version 7.1.000

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

FUJIFILM Healthcare Americas Corporation

5 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Mar 13, 2024

X3 TRIATHLON CS INSERT NO 3 10 MM

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Howmedica Osteonics Corp.

7 more products in this recall

FDA (openFDA device enforcement)

Free recall alerts

Get alerted about new Medical device recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Related categories

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.