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 8, 2022
Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bio-Rad Laboratories, Inc.
FDA (openFDA device enforcement)
Reported Jun 8, 2022
I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalog Number: 822
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Busse Hospital Disposables, Inc.
57 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 8, 2022
DYNEX Agility, Agility Analyzer, Model No. 67000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dynex Technologies, Inc.
FDA (openFDA device enforcement)
Reported Jun 8, 2022
VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 8, 2022
Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ion Beam Applications S.A.
FDA (openFDA device enforcement)
Reported Jun 8, 2022
MEDLINE Polyurethane Foam Enzymatic Cleaning Sponge, REF DYK1000TSE
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 8, 2022
The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA (openFDA device enforcement)
Reported Jun 8, 2022
NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Xomed, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 8, 2022
PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MicroPort Orthopedics Inc.
FDA (openFDA device enforcement)
Reported Jun 8, 2022
Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tornier, Inc.
FDA (openFDA device enforcement)
Reported Jun 8, 2022
XVIVO Organ Chamber REF 19020
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Xvivo Perfusion Ab
FDA (openFDA device enforcement)
Reported Jun 1, 2022
The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to specifically…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Accriva Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Jun 1, 2022
Sara Plus Active Floor Lift
High riskUsing this product could cause serious injury, illness or death — stop using it now.ARJOHUNTLEIGH POLSKA Sp. z.o.o.
FDA (openFDA device enforcement)
Reported Jun 1, 2022
SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ConvaTec, Inc.
FDA (openFDA device enforcement)
Reported Jun 1, 2022
HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Devicor Medical Products Inc.
FDA (openFDA device enforcement)
Reported Jun 1, 2022
Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R, Multi-Use 2.2mm Double Bevel Slit,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.International Science & Technology, LP, dba Diamatrix Ltd.
FDA (openFDA device enforcement)
Reported Jun 1, 2022
Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Invacare Corporation
FDA (openFDA device enforcement)
Reported Jun 1, 2022
ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
FDA (openFDA device enforcement)
Reported Jun 1, 2022
Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 1, 2022
Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
FDA (openFDA device enforcement)
Reported Jun 1, 2022
KWIK-STIK" plus: Clostridium perfringens
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Microbiologics Inc.
FDA (openFDA device enforcement)
Reported Jun 1, 2022
Olympus DISPOSABLE GRASPING FORCEPS, FG-51D
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Jun 1, 2022
progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x 2 cm; (2) PM3002, 2…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ProgenaCare
FDA (openFDA device enforcement)
Reported Jun 1, 2022
INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew Orthopaedics GmbH
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.