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.
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)
Reported Jul 9, 2025
Philips 3D9-3v Transducer.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Ultrasound, Inc.
20 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 9, 2025
ADVIA¿ 120/2120/2120i SETpoint Calibrator
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 9, 2025
ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 2, 2025
Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Barco N.V.
FDA (openFDA device enforcement)
Reported Jul 2, 2025
REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Inc.
FDA (openFDA device enforcement)
Reported Jul 2, 2025
DxI 9000 Access Immunoassay Analyzer C11137
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Jul 2, 2025
BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
FDA (openFDA device enforcement)
Reported Jul 2, 2025
REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson Infusion Therapy Systems, Inc.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 2, 2025
Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bigfoot Biomedical
FDA (openFDA device enforcement)
Reported Jul 2, 2025
Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
FDA (openFDA device enforcement)
Reported Jul 2, 2025
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Encore Medical, LP
3 more products in this recall
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.