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 Sep 8, 2021
CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zeltiq Aesthetics, Inc.
FDA (openFDA device enforcement)
Reported Sep 1, 2021
Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Inc.
FDA (openFDA device enforcement)
Reported Sep 1, 2021
BD" Mouse IgG2a Isotype Control APC X39 ASR
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton, Dickinson and Company, BD Biosciences
FDA (openFDA device enforcement)
Reported Sep 1, 2021
AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BioMimetic Therapeutics, LLC
FDA (openFDA device enforcement)
Reported Sep 1, 2021
Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cardinal Health
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 1, 2021
ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
FDA (openFDA device enforcement)
Reported Sep 1, 2021
AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Encore Medical, LP
FDA (openFDA device enforcement)
Reported Sep 1, 2021
HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon Endo-Surgery Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 1, 2021
ECHELON MRI System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hitachi Healthcare Americas Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 1, 2021
NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Northeast Scientific Inc.
FDA (openFDA device enforcement)
Reported Sep 1, 2021
Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler (USV2). Intended Use: Vascular…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Oakworks Inc.
FDA (openFDA device enforcement)
Reported Sep 1, 2021
Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
6 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 1, 2021
AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Procept Biorobotics Corporation
FDA (openFDA device enforcement)
Reported Sep 1, 2021
Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diabetes Care, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 1, 2021
KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Straumann USA LLC
FDA (openFDA device enforcement)
Reported Sep 1, 2021
Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
FDA (openFDA device enforcement)
Reported Sep 1, 2021
Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.W. L. Gore & Associates Inc.
FDA (openFDA device enforcement)
Reported Aug 25, 2021
TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 25, 2021
Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cardinal Health 200, LLC
FDA (openFDA device enforcement)
Reported Aug 25, 2021
Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Cell Marque Corporation
FDA (openFDA device enforcement)
Reported Aug 25, 2021
Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CooperSurgical, Inc.
FDA (openFDA device enforcement)
Reported Aug 25, 2021
Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cytocell Ltd.
FDA (openFDA device enforcement)
Reported Aug 25, 2021
DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Delta Med SpA
10 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 25, 2021
NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Epimed International
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.