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 29, 2026
Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
FDA (openFDA device enforcement)
Reported Jul 29, 2026
SnapshotGLO Wound Imaging Device, Model KB100, KB100AA.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Kent Imaging, Inc.
FDA (openFDA device enforcement)
Reported Jul 29, 2026
MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medline Industries, LP
17 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 29, 2026
MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
FDA (openFDA device enforcement)
Reported Jul 29, 2026
Ventriculostomy Kit, REF: 46154
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neurosurgery
FDA (openFDA device enforcement)
Reported Jul 29, 2026
Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12. Intracranial aneurysm…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Micro Therapeutics, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 29, 2026
Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displaying…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 29, 2026
P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Paragon 28, Inc.
FDA (openFDA device enforcement)
Reported Jul 29, 2026
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Penumbra, Inc.
FDA (openFDA device enforcement)
Reported Jul 29, 2026
3mensio Workstation (Vascular Fenestrated) software
Moderate riskThis product could cause temporary or reversible health problems — stop using it.PIE Medical Imaging B.V.
FDA (openFDA device enforcement)
Reported Jul 29, 2026
Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT Product Description:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Prismatik Dentalcraft, Inc.
FDA (openFDA device enforcement)
Reported Jul 29, 2026
SeaSpine Polyaxial Head REF Number: 41-3010
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Seaspine Orthopedics Corporation
FDA (openFDA device enforcement)
Reported Jul 29, 2026
The intended use is to be paired with a weapon for aiming purposes.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wilcox Industries Corp.
FDA (openFDA device enforcement)
Reported Jul 22, 2026
Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small), RII1002…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.3B Medical, Inc.
FDA (openFDA device enforcement)
Reported Jul 22, 2026
ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abiomed, Inc.
12 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 22, 2026
Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
High riskUsing this product could cause serious injury, illness or death — stop using it now.Argon Medical Devices, Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 22, 2026
Rapid Refill Continuous Injection System, UPN M00566001
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
FDA (openFDA device enforcement)
Reported Jul 22, 2026
Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Daavlin Distributing Company
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 22, 2026
Optima XR200amx, Mobile Digital-Ready Radiographic System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 22, 2026
ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; 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 Jul 22, 2026
da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
FDA (openFDA device enforcement)
Reported Jul 22, 2026
The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile, single-use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
FDA (openFDA device enforcement)
Reported Jul 22, 2026
Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medline Industries, LP
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 22, 2026
Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
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.