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 Jul 16, 2025
Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Research LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 16, 2025
Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mobile Patient Lifts: 1) Uno 102 EE Mobile…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 16, 2025
VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (180J RF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 16, 2025
Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Canary Medical, Inc.
FDA (openFDA device enforcement)
Reported Jul 16, 2025
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Edwards Lifesciences, LLC
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 16, 2025
Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ge Medical Systems Israel, Functional Imaging
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 16, 2025
Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Given Imaging Ltd.
FDA (openFDA device enforcement)
Reported Jul 16, 2025
O-arm O2 Imaging System. Mobile X-Ray System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.-Boxborough
FDA (openFDA device enforcement)
Reported Jul 16, 2025
Brand Name: Hummingbird Product Name: Stimulated EMG Kit with Hummingbird - Model/Catalog Number: REF I-D-BMF90, 1…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Neurovision Medical Products Inc.
FDA (openFDA device enforcement)
Reported Jul 16, 2025
Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Preat Corp.
FDA (openFDA device enforcement)
Reported Jul 16, 2025
TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Stratasys Ltd.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 9, 2025
REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton, Dickinson and Company, BD Bio Sciences
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 9, 2025
BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 21114, 20Fr - REF:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.C.R. Bard Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 9, 2025
Change Healthcare Cardiology Hemo Software
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Change Healthcare Canada Company
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 9, 2025
Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Corin Medical, Ltd.
FDA (openFDA device enforcement)
Reported Jul 9, 2025
ColoSense Test Kit, Part No. 80-001, component of ColoSense test
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Geneoscopy, Inc.
FDA (openFDA device enforcement)
Reported Jul 9, 2025
HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hardy Diagnostics
FDA (openFDA device enforcement)
Reported Jul 9, 2025
The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.HemoCue AB
FDA (openFDA device enforcement)
Reported Jul 9, 2025
Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macular Degeneration…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Lumithera Inc.
FDA (openFDA device enforcement)
Reported Jul 9, 2025
Servo-u Ventilator System. Model Number: 6688600.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Maquet Critical Care AB
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 9, 2025
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 9, 2025
My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Onkos Surgical, Inc.
FDA (openFDA device enforcement)
Reported Jul 9, 2025
Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 9, 2025
BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Philips Respironics, Inc.
2 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.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.
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.