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 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)
Reported Jun 25, 2025
SURGIMESH WN, Polymeric Surgical Mesh, Large Flat Sheet, Model/Catalog Number: T3030
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Chamberlain Technologies LLC
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 25, 2025
Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cook Incorporated
FDA (openFDA device enforcement)
Reported Jun 25, 2025
Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1)
High riskUsing this product could cause serious injury, illness or death — stop using it now.Dexcom, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 25, 2025
STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Diagnostica Stago, Inc.
FDA (openFDA device enforcement)
Reported Jun 25, 2025
5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
FDA (openFDA device enforcement)
Reported Jun 25, 2025
Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catalog Number: PM001 Software Version:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Guangzhou Pluslife Biotech Co., Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 25, 2025
AcoSound. Model Number: LW12-BTE-M
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Hangzhou Acosound Technology Co., Ltd.
FDA (openFDA device enforcement)
Reported Jun 25, 2025
ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 25, 2025
GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ohio Medical Corporation
FDA (openFDA device enforcement)
Reported Jun 25, 2025
REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Orthofix Srl
FDA (openFDA device enforcement)
Reported Jun 25, 2025
Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Preat Corp.
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.