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 Oct 4, 2023
MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Waldemar Link GmbH & Co. KG (Mfg Site)
FDA (openFDA device enforcement)
Reported Oct 4, 2023
Henke-Ject-2 part luer sterile single use syringes - used for intravenous, intramuscular, subcutaneous, intracutaneous…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wolf, Henke Sass, GmbH
FDA (openFDA device enforcement)
Reported Oct 4, 2023
Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.WOM World Of Medicine AG
FDA (openFDA device enforcement)
Reported Sep 27, 2023
Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Medical
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 27, 2023
APK2 Pressure-Sensing Wheelchair Cushions
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aquila Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 27, 2023
Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ARROW INTERNATIONAL Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 27, 2023
COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Avanos Medical, Inc.
FDA (openFDA device enforcement)
Reported Sep 27, 2023
Perifix¿ / Epidural anesthesia set, medicated
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
FDA (openFDA device enforcement)
Reported Sep 27, 2023
COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Copan Diagnostics Inc.
FDA (openFDA device enforcement)
Reported Sep 27, 2023
DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Encore Medical, LP
4 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 27, 2023
PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 27, 2023
Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems Information Technologies Inc.
FDA (openFDA device enforcement)
Reported Sep 27, 2023
Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator
High riskUsing this product could cause serious injury, illness or death — stop using it now.Hamilton Medical, Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 27, 2023
Omnipod 5 Automated Insulin Delivery System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Insulet Corporation
FDA (openFDA device enforcement)
Reported Sep 27, 2023
Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
FDA (openFDA device enforcement)
Reported Sep 27, 2023
MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
FDA (openFDA device enforcement)
Reported Sep 27, 2023
FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.O&m Halyard, Inc.
FDA (openFDA device enforcement)
Reported Sep 27, 2023
VITROS XT Chemistry Products TBIL-ALKP Slides
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 27, 2023
Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
FDA (openFDA device enforcement)
Reported Sep 27, 2023
MINISCAV (tm) Vacuum Pump
Moderate riskThis product could cause temporary or reversible health problems — stop using it.R A Medical Services
FDA (openFDA device enforcement)
Reported Sep 27, 2023
Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Randox Laboratories Ltd.
FDA (openFDA device enforcement)
Reported Sep 27, 2023
Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007, when Used…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Remote Diagnostic Technologies Ltd.
FDA (openFDA device enforcement)
Reported Sep 27, 2023
Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.SenTec AG
FDA (openFDA device enforcement)
Reported Sep 27, 2023
smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew 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.