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 Dec 4, 2024
4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 28206CBS Full Radius Resector, sterile, 6x 5.5…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
FDA (openFDA device enforcement)
Reported Dec 4, 2024
V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound Therapy System is an…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Kci USA, Inc.
FDA (openFDA device enforcement)
Reported Dec 4, 2024
Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Kreatech Biotechnology Bv
FDA (openFDA device enforcement)
Reported Dec 4, 2024
Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LivaNova Deutschland GmbH
FDA (openFDA device enforcement)
Reported Dec 4, 2024
MEDLINE NEXUS 19/20G CATH CONNECTOR, Medline SKU REF NEXCONNECT, Catheter Connector
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
11 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 4, 2024
MICRO-X Rover Mobile X-ray System, # MXU-RV35
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Micro-X Ltd.
FDA (openFDA device enforcement)
Reported Dec 4, 2024
Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads (Forceps…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MicroSurgical Technology Inc.
FDA (openFDA device enforcement)
Reported Dec 4, 2024
VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Dec 4, 2024
Achieva TX Interventional Coil 3.0T
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
12 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 4, 2024
Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Remote Diagnostic Technologies Ltd.
FDA (openFDA device enforcement)
Reported Dec 4, 2024
Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjunction with the Arial Mobile Application or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Securitas Healthcare LLC
FDA (openFDA device enforcement)
Reported Dec 4, 2024
Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Shimadzu Corp. Analytical & Measuring Instruments Div.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 4, 2024
RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew Medical, Ltd.
FDA (openFDA device enforcement)
Reported Dec 4, 2024
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 4, 2024
Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Zyno Medical LLC
FDA (openFDA device enforcement)
Reported Nov 27, 2024
Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Medical
4 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 27, 2024
a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR;…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Alcon Research LLC
FDA (openFDA device enforcement)
Reported Nov 27, 2024
Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210; BARD MARQUEE 12G X 10…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bard Peripheral Vascular Inc.
FDA (openFDA device enforcement)
Reported Nov 27, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
9 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 27, 2024
JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
FDA (openFDA device enforcement)
Reported Nov 27, 2024
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Caire, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 27, 2024
Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Incorporated
FDA (openFDA device enforcement)
Reported Nov 27, 2024
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoor…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Enchroma Inc.
FDA (openFDA device enforcement)
Reported Nov 27, 2024
MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
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.