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 May 19, 2021
Regard Dressing Change Tray
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
FDA (openFDA device enforcement)
Reported May 19, 2021
ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL Assurity and Endurity pacemakers are intended to…
High riskUsing this product could cause serious injury, illness or death — stop using it now.St. Jude Medical, Cardian Rhythm Management Division
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 19, 2021
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
High riskUsing this product could cause serious injury, illness or death — stop using it now.Step-Har Medical LLC
FDA (openFDA device enforcement)
Reported May 12, 2021
DJO EMPOWR KNEE Femoral Sizer
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Encore Medical, LP
FDA (openFDA device enforcement)
Reported May 12, 2021
Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
FDA (openFDA device enforcement)
Reported May 12, 2021
VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Greiner Bio-One North America, Inc.
FDA (openFDA device enforcement)
Reported May 12, 2021
LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LeMaitre Vascular, Inc.
FDA (openFDA device enforcement)
Reported May 12, 2021
CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
5 more products in this recall
FDA (openFDA device enforcement)
Reported May 12, 2021
Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
FDA (openFDA device enforcement)
Reported May 12, 2021
Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
FDA (openFDA device enforcement)
Reported May 12, 2021
Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel filter - Product Usage: intended to be…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Oto Med Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 5, 2021
Filtered Triple-Leg Extension Set - Intravascular administration set. Product Catalog number: 477034 - Product Usage:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
FDA (openFDA device enforcement)
Reported May 5, 2021
Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled administration of fluids.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported May 5, 2021
Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 5, 2021
Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840-2417 - LS Tandem…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardiac Assist, Inc.
FDA (openFDA device enforcement)
Reported May 5, 2021
Change Healthcare Enterprise Viewer
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Change Healthcare Canada Company
FDA (openFDA device enforcement)
Reported May 5, 2021
Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Clark Laboratories, Inc.
FDA (openFDA device enforcement)
Reported May 5, 2021
Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use for dental…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Coltene Whaledent Inc.
FDA (openFDA device enforcement)
Reported May 5, 2021
INFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE100…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ConMed Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 5, 2021
Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cytocell Ltd.
FDA (openFDA device enforcement)
Reported May 5, 2021
Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Datascope Corp.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 5, 2021
DONJOY REF:11-0447-9-ULTRASLING PRO, UNIVERSAL, Rx ONLY, UDI:(01)00190446673552 - Product Usage: intended for medical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DJ Orthopedics de Mexico S.A. de C.V.
3 more products in this recall
FDA (openFDA device enforcement)
Reported May 5, 2021
VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Luminex Corporation
FDA (openFDA device enforcement)
Reported May 5, 2021
Stryker Medela REF 077.0193 AXS Universal Aspiration Tubing (01)07612367053921 - Product Usage: AXS Universal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medela AG Medical Technology
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.