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 Jun 22, 2022
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tandem Diabetes Care Inc.
FDA (openFDA device enforcement)
Reported Jun 22, 2022
Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Volcano Corp.
FDA (openFDA device enforcement)
Reported Jun 15, 2022
(1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped padding and one plastic-wrapped…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BSN Medical Inc.
FDA (openFDA device enforcement)
Reported Jun 15, 2022
Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Incorporated
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 15, 2022
DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Encore Medical, LP
FDA (openFDA device enforcement)
Reported Jun 15, 2022
Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM…
High riskUsing this product could cause serious injury, illness or death — stop using it now.GE Healthcare, LLC
6 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 15, 2022
Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector for the washing,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Getinge USA Sales Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 15, 2022
V8 Immunodisplacement Kit REF 1803
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Helena Laboratories, Corp.
FDA (openFDA device enforcement)
Reported Jun 15, 2022
Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
FDA (openFDA device enforcement)
Reported Jun 15, 2022
STORZ KARL STORZ-ENDOSKOPE REF 11272VUE CMOS Video Cysto-Urethroscope REF 11272VUEK CMOS Video Cysto-Urethroscope…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
FDA (openFDA device enforcement)
Reported Jun 15, 2022
GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medacta USA Inc.
FDA (openFDA device enforcement)
Reported Jun 15, 2022
MedMinder Medication Dispenser- Intended to serve as a medication reminder to promote medication adherence with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medminder Systems, Inc.
FDA (openFDA device enforcement)
Reported Jun 15, 2022
HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Inc.
FDA (openFDA device enforcement)
Reported Jun 15, 2022
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900
Moderate riskThis product could cause temporary or reversible health problems — stop using it.NeuMoDx Molecular Inc.
FDA (openFDA device enforcement)
Reported Jun 15, 2022
1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.New Standard Device Inc.
FDA (openFDA device enforcement)
Reported Jun 15, 2022
AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Northgate Technologies, Inc.
FDA (openFDA device enforcement)
Reported Jun 15, 2022
PX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C19
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Oakworks Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 15, 2022
Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 15, 2022
Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 15, 2022
Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502…
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 Jun 15, 2022
Reliance Synergy Washer/Disinfector
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
FDA (openFDA device enforcement)
Reported Jun 8, 2022
FIRMap" Catheter, 60mm Basket
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott
FDA (openFDA device enforcement)
Reported Jun 8, 2022
In-Line ventilator adaptor
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 8, 2022
BD Anti-Kappa APC (Cat. No. 341098) is an analyte specific reagent for the Anti-Kappa antibody, which specifically…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton, Dickinson and Company, BD Biosciences
1 more product 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.