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 Mar 12, 2025
MIM software; System, Image Processing, Radiological
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MIM Software Inc.
FDA (openFDA device enforcement)
Reported Mar 12, 2025
Vios Monitoring System Bedside Monitor Model BSM2050
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Murata Vios, Inc.
FDA (openFDA device enforcement)
Reported Mar 12, 2025
Philips IntelliSpace Cardiovascular software, Model 830089.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.V.
FDA (openFDA device enforcement)
Reported Mar 12, 2025
TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.TAS Medical Inc.
FDA (openFDA device enforcement)
Reported Mar 12, 2025
Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Telcare, LLC
FDA (openFDA device enforcement)
Reported Mar 5, 2025
DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Laboratory Systems (suzhou) Co., Ltd.
FDA (openFDA device enforcement)
Reported Mar 5, 2025
BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 5, 2025
SIGNA Creator, SIGNA Explorer, NMRI systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare (China) Co., Ltd.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 5, 2025
IntelePACS (Image Fusion Module) - InteleViewer
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intelerad Medical Systems Incorporated
FDA (openFDA device enforcement)
Reported Mar 5, 2025
Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Leica Biosystems Nussloch GmbH
FDA (openFDA device enforcement)
Reported Mar 5, 2025
PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Pentax
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 5, 2025
LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Physio-Control, Inc.
FDA (openFDA device enforcement)
Reported Mar 5, 2025
Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration System with a compatible…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Scientia Vascular, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 5, 2025
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terragene S.a.
FDA (openFDA device enforcement)
Reported Mar 5, 2025
A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 4H LT: Anatomic Lateral Fibula Plate, 4-hole, Left Intended for Fixation of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tyber Medical
17 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 5, 2025
VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF:…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Ventec Life Systems, Inc.
FDA (openFDA device enforcement)
Reported Feb 26, 2025
Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136 used in conjunction with Warming…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Augustine Temperature Management, LLC
4 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 26, 2025
DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DeRoyal Industries Inc.
FDA (openFDA device enforcement)
Reported Feb 26, 2025
Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dexcom, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 26, 2025
AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700,
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hollister Incorporated
3 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 26, 2025
3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Kci USA, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 26, 2025
Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit
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 Feb 26, 2025
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
High riskUsing this product could cause serious injury, illness or death — stop using it now.Philips Medical Systems Nederland B.v.
19 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 26, 2025
LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO, SpO2, and SpMet, Adult Adhesive Sensors REF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Physio-Control, Inc.
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.