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 Jan 11, 2023
Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed
FDA (openFDA device enforcement)
Reported Jan 11, 2023
VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Jan 11, 2023
Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Randox Laboratories Ltd.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 11, 2023
Programmable Diagnostic Computer
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Jan 11, 2023
VERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Number: S3060 Intended for use in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 11, 2023
Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M Custom Lasik Kit…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Windstone Medical Packaging, Inc.
FDA (openFDA device enforcement)
Reported Jan 4, 2023
Part Number/Part Description: 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose AM-0025-S 25.0mm Acutrak¿ 4/5 Bone Screw…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Acumed LLC
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 4, 2023
Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Remington Medical, Inc.
FDA (openFDA device enforcement)
Reported Jan 4, 2023
Pilling Wecksorb Cylindrical Sponges
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex LLC
FDA (openFDA device enforcement)
Reported Dec 28, 2022
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Molecular, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 28, 2022
Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failure by hemodialysis.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
4 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 28, 2022
InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA, MMT-105ELGYNA, MMT-105ELPKNA,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Companion Medical, Inc.
FDA (openFDA device enforcement)
Reported Dec 28, 2022
ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ConvaTec, Inc.
FDA (openFDA device enforcement)
Reported Dec 28, 2022
Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Corin Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 28, 2022
DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DeVilbiss Healthcare LLC
FDA (openFDA device enforcement)
Reported Dec 28, 2022
2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
FDA (openFDA device enforcement)
Reported Dec 28, 2022
Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and data…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
14 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 28, 2022
HeartWare Model 1100
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Heartware, Inc.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 28, 2022
Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Howmedica Osteonics Corp.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 28, 2022
VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Icotec Ag
FDA (openFDA device enforcement)
Reported Dec 28, 2022
Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter introduction kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medical Action Industries, Inc. 306
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 28, 2022
The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Natus Medical Incorporated
FDA (openFDA device enforcement)
Reported Dec 28, 2022
X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.NuVasive Inc.
FDA (openFDA device enforcement)
Reported Dec 28, 2022
The product is a handheld ultraviolet-C germicidal wand and contains narrow-diameter, tubular lamps with a peak…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Phonesoap
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.