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 Apr 27, 2022
Merlin PCS 3650 programmer Model 3330 software
Moderate riskThis product could cause temporary or reversible health problems — stop using it.St. Jude Medical, Cardiac Rhythm Management Division
4 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 27, 2022
Cardiovascular Procedure Kit catalog # 76645 & 73806
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corp.
FDA (openFDA device enforcement)
Reported Apr 20, 2022
20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Vascular
4 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 20, 2022
Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (BIC) - VERSION 2,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B Braun Medical Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 20, 2022
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 20, 2022
Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Breas Medical, Inc.
FDA (openFDA device enforcement)
Reported Apr 20, 2022
Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
FDA (openFDA device enforcement)
Reported Apr 20, 2022
iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Conformis, Inc.
FDA (openFDA device enforcement)
Reported Apr 20, 2022
Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Deerfield Imaging, Inc.
FDA (openFDA device enforcement)
Reported Apr 20, 2022
MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
FDA (openFDA device enforcement)
Reported Apr 20, 2022
CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-US
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Graphic Controls Acquisition Corporation
5 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 20, 2022
Integra Universal Flexible Arm part number REF 1362275
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
FDA (openFDA device enforcement)
Reported Apr 20, 2022
LIPOSORBER System, Model: LA-15, consisting of: Apheresis machine, product# 101445 model: MA-03, and disposables…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Kaneka America Corp.
FDA (openFDA device enforcement)
Reported Apr 20, 2022
Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Luminex Corporation
FDA (openFDA device enforcement)
Reported Apr 20, 2022
Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 20, 2022
Access-9 Large Bore Hemostasis Valves, Catalog Code: 580775001, IN8112/C, K05-00053H, K05-00109G, K05-00137K,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 20, 2022
Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic surgical instrument
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nextremity Solutions
4 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 20, 2022
The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America, LLC
FDA (openFDA device enforcement)
Reported Apr 20, 2022
Cub 2 Enclosed Bed Canopy System
High riskUsing this product could cause serious injury, illness or death — stop using it now.Sensory Medical Inc.
FDA (openFDA device enforcement)
Reported Apr 20, 2022
Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 20, 2022
Separation Technology Creamatocrit Plus, Catalog Number: 100-146
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stanbio Laboratory, LP
FDA (openFDA device enforcement)
Reported Apr 20, 2022
ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Varian Medical Systems Imaging Laboratory GmbH
FDA (openFDA device enforcement)
Reported Apr 20, 2022
IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Volcano Corp.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 13, 2022
ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
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.