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 5, 2021
Power Wheelchair
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merits Holdings Co. dba Merits Health Products, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 5, 2021
InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage: Intended as a three-part construct…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nextremity Solutions
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 5, 2021
Omnia Soft Tissue Punch is a dental instrument designed to remove with precision a circular section of oral soft tissue…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Omnia SRL
FDA (openFDA device enforcement)
Reported May 5, 2021
VITROS¿ Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported May 5, 2021
Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices - intended for use by…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
FDA (openFDA device enforcement)
Reported May 5, 2021
Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 5, 2021
CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for interference fixation of bone-tendon-bone of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
FDA (openFDA device enforcement)
Reported May 5, 2021
Palm Cups - Product Usage: intended to be used to percuss the chest wall to mobilize the secretions within the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 28, 2021
Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics Inc. (Navilyst Medical Inc.)
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 28, 2021
Assure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch Label - FaStep Rapid Diagnostic Test *** Rapid…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Azure Biotech Inc.
FDA (openFDA device enforcement)
Reported Apr 28, 2021
BIOTRONIK Ilestro 7 DR-T, DF-1, REF383562, UDI: 04035479125189 - Product Usage: intended to provide ventricular…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BIOTRONIK Inc.
24 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 28, 2021
The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing saline. The system is made out of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
FDA (openFDA device enforcement)
Reported Apr 28, 2021
Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.C.R. Bard, Inc.
FDA (openFDA device enforcement)
Reported Apr 28, 2021
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system components: HVAD Sterile…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Heartware, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 28, 2021
Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 28, 2021
Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Pacific Medical Group Inc.
FDA (openFDA device enforcement)
Reported Apr 28, 2021
BCS XP System: Multipurpose system for in vitro coagulation studies. Product code: 10459330, 10461894, 10470625 -…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Apr 28, 2021
Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Apr 28, 2021
LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitoring and blood sampling.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
11 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 28, 2021
DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Leibinger GmbH & Co. KG
FDA (openFDA device enforcement)
Reported Apr 28, 2021
Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar. Catalogs:TL Inserter (580220100), TL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Spine
FDA (openFDA device enforcement)
Reported Apr 28, 2021
Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Trinity Sterile, Inc.
FDA (openFDA device enforcement)
Reported Apr 28, 2021
ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Welch Allyn Inc. Mortara
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 21, 2021
Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Arthrex, 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.