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 29, 2021
Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
FDA (openFDA device enforcement)
Reported Dec 29, 2021
regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
FDA (openFDA device enforcement)
Reported Dec 29, 2021
Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stradis Medical, LLC dba Stradis Healthcare
FDA (openFDA device enforcement)
Reported Dec 29, 2021
Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wright Medical Technology Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 29, 2021
Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wright Medical Technology, Inc.
FDA (openFDA device enforcement)
Reported Dec 22, 2021
Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5 User Manual: ACTIV5 USER MANUAL Welcome to Activ5,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Activbody, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 22, 2021
Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
FDA (openFDA device enforcement)
Reported Dec 22, 2021
SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health
10 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 22, 2021
Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Clark Laboratories, Inc.
FDA (openFDA device enforcement)
Reported Dec 22, 2021
Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44154…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 22, 2021
BioGlue Surgical Adhesive, Model BG3510-5-G
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CryoLife, Inc.
FDA (openFDA device enforcement)
Reported Dec 22, 2021
Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Datascope Corp.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 22, 2021
EVLP Convenience Pack/Kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medline Industries Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 22, 2021
Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 22, 2021
MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mentor Texas, LP.
FDA (openFDA device enforcement)
Reported Dec 22, 2021
EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Dec 22, 2021
Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ossur Americas
FDA (openFDA device enforcement)
Reported Dec 22, 2021
smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 22, 2021
Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Xstrahl Limited
FDA (openFDA device enforcement)
Reported Dec 15, 2021
SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM; 701114150/SUPERCORE…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Argon Medical Devices, Inc.
FDA (openFDA device enforcement)
Reported Dec 15, 2021
Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
16 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 15, 2021
Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Northgate Technologies, Inc.
FDA (openFDA device enforcement)
Reported Dec 15, 2021
O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Orchestrate Orthodontic Technologies, Inc.
FDA (openFDA device enforcement)
Reported Dec 15, 2021
OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Osteomed, LLC
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.