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 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)
Reported Feb 26, 2025
Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System. Model/Catalog Number: 7.0.0.19,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
10 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 26, 2025
remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Remel, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 26, 2025
Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty:…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Spectranetics Corporation
FDA (openFDA device enforcement)
Reported Feb 26, 2025
Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11mm, PC (STERILE))…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.XTANT Medical Holdings, Inc.
FDA (openFDA device enforcement)
Reported Feb 19, 2025
Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angel Medical Systems, Inc.
FDA (openFDA device enforcement)
Reported Feb 19, 2025
Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP , Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
11 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 19, 2025
(1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 19, 2025
MOSAIQ Oncology Information System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Elekta, Inc.
FDA (openFDA device enforcement)
Reported Feb 19, 2025
AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-32-27 AM EHXL 0¿ LNR G 32MM…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 19, 2025
Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Getinge USA Sales Inc.
FDA (openFDA device enforcement)
Reported Feb 19, 2025
Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.HF Acquisition Co. LLC
FDA (openFDA device enforcement)
Reported Feb 19, 2025
Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hologic, Inc.
FDA (openFDA device enforcement)
Reported Feb 19, 2025
Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences 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.