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 Feb 24, 2021
Valkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423). Blood collection convenience kit. The Valkyrie LTOWB…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Combat Medical Systems, LLC
4 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 24, 2021
Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCC)V-402a - Product Usage: is a lateral…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Confirm Biosciences Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 24, 2021
System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 24, 2021
Getinge CM320 Series Washer Disinfector - Product Usage: A multi chamber washer disinfector intended for washing,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Getinge Group Logistics America, LLC
FDA (openFDA device enforcement)
Reported Feb 24, 2021
LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LumiraDx
FDA (openFDA device enforcement)
Reported Feb 24, 2021
Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers: 24048 - VALVE 24048…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neurosurgery
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 24, 2021
SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.SenTec AG
FDA (openFDA device enforcement)
Reported Feb 24, 2021
AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE, Whole…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sky Medical Supplies and Equipments LLC
FDA (openFDA device enforcement)
Reported Feb 17, 2021
B5-2Q BALLOON CATHETER, Model No. B5-2Q - Product Usage: Used with endoscopes to inject contrast medium or other…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aomori Olympus Co., Ltd.
110 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 17, 2021
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18S, 1/18 GA Flexcore Biopsy Needle, 1/7F…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Argon Medical Devices, Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 17, 2021
Arjo Flat Dynamic Positioning System (DPS) - Product Usage: used in conjunction with passive clip slings is designed…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Arjohuntleigh Magog, Inc.
FDA (openFDA device enforcement)
Reported Feb 17, 2021
Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central circulation by the way of the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Arrow International Inc.
FDA (openFDA device enforcement)
Reported Feb 17, 2021
Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector, Neutral Fluid…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported Feb 17, 2021
BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
FDA (openFDA device enforcement)
Reported Feb 17, 2021
Bemer-Set/ Pro-Set for the following models: REF. 410201 (BEMER Pro-Set), REF. 420201 (B.BOX Professional), REF. 420100…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bemer Int. Ag
FDA (openFDA device enforcement)
Reported Feb 17, 2021
EMBLEM S-ICD Model A209
High riskUsing this product could cause serious injury, illness or death — stop using it now.Boston Scientific Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 17, 2021
Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108K
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
18 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 17, 2021
Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
FDA (openFDA device enforcement)
Reported Feb 17, 2021
Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2 Distal probe, labelled in green, consists of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cytocell Ltd.
FDA (openFDA device enforcement)
Reported Feb 17, 2021
Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
FDA (openFDA device enforcement)
Reported Feb 17, 2021
Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for multi-parameter, physiologic patient…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Draegar Medical Systems, Inc.
FDA (openFDA device enforcement)
Reported Feb 17, 2021
GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System - Product Usage: Intended for use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
FDA (openFDA device enforcement)
Reported Feb 17, 2021
Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Helena Laboratories, Corp.
FDA (openFDA device enforcement)
Reported Feb 17, 2021
60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravascular administration…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
3 more products in this recall
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.