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 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)
Reported Jul 2, 2025
GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems China Co., Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 2, 2025
Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version: all…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Insulet Corporation
FDA (openFDA device enforcement)
Reported Jul 2, 2025
Extended Tip Applicator, 8CM, Box of 5.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Integra LifeSciences Corp. (NeuroSciences)
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 2, 2025
Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Jewel Precision Sheet Metal & Machining Co., Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 2, 2025
LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external cardiac compressions on adult…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Jolife AB
FDA (openFDA device enforcement)
Reported Jul 2, 2025
PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Limacorporate S.p.A
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 2, 2025
Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
FDA (openFDA device enforcement)
Reported Jul 2, 2025
Spectral CT. Computed tomography X-ray system.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
FDA (openFDA device enforcement)
Reported Jul 2, 2025
Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Recordati Rare Diseases Inc.
FDA (openFDA device enforcement)
Reported Jul 2, 2025
Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Jul 2, 2025
Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and…
High riskUsing this product could cause serious injury, illness or death — stop using it now.SunMed Holdings, LLC
FDA (openFDA device enforcement)
Reported Jul 2, 2025
CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
FDA (openFDA device enforcement)
Reported Jun 25, 2025
Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Balt USA, LLC
1 more product 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.