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 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)
Reported Nov 27, 2024
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hobbs Medical, Inc.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 27, 2024
Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion…
High riskUsing this product could cause serious injury, illness or death — stop using it now.ICU Medical, Inc.
FDA (openFDA device enforcement)
Reported Nov 27, 2024
Acrobat-i Positioner. Model Number C-XP-5000Z
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 27, 2024
NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total Hip System is a non-cemented hip…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Novosource, LLC
FDA (openFDA device enforcement)
Reported Nov 27, 2024
Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE MAX…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.NuVasive Specialized Orthopedics, Inc.
FDA (openFDA device enforcement)
Reported Nov 27, 2024
Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Nov 27, 2024
OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers. Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.OrganOx Ltd.
FDA (openFDA device enforcement)
Reported Nov 27, 2024
Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Technologies Ltd.
FDA (openFDA device enforcement)
Reported Nov 27, 2024
cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
FDA (openFDA device enforcement)
Reported Nov 27, 2024
Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Nov 27, 2024
smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD, Inc.
FDA (openFDA device enforcement)
Reported Nov 27, 2024
Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zyno Medical LLC
FDA (openFDA device enforcement)
Reported Nov 20, 2024
Halyard IR ABCESS DRAINAGE PACK - Medical convenience kits Model Number: AVMD018
Moderate riskThis product could cause temporary or reversible health problems — stop using it.AVID Medical, Inc.
72 more products in this recall
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.