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 May 26, 2021
BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biopsybell S.r.l.
18 more products in this recall
FDA (openFDA device enforcement)
Reported May 26, 2021
Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bioseal Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 26, 2021
VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Boston Scientific Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 26, 2021
Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) -…
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 May 26, 2021
Medtronic, REF: MMT-7008A, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 5PK 23L 1CL /GTIN:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
19 more products in this recall
FDA (openFDA device enforcement)
Reported May 26, 2021
RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 10A, 10B including some of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 26, 2021
Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 26, 2021
GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.W.L. Gore & Associates, Inc.
FDA (openFDA device enforcement)
Reported May 26, 2021
Alpha Interlock Suspension System Lanyard Body: An external prosthetic device. The Alpha Lanyard includes suction with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.WillowWood Global LLC
FDA (openFDA device enforcement)
Reported May 19, 2021
NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories Inc. (St Jude Medical)
FDA (openFDA device enforcement)
Reported May 19, 2021
ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits to the lower limbs and part of the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Argo Medical Technologies Ltd.
FDA (openFDA device enforcement)
Reported May 19, 2021
Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Atos Medical AB
FDA (openFDA device enforcement)
Reported May 19, 2021
PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bard Peripheral Vascular Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 19, 2021
AquaBplus and AquaBplus B2 Water Purification System - Product Usage: Intended for use with a hemodialysis system to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
FDA (openFDA device enforcement)
Reported May 19, 2021
NM/CT 850 Nuclear Medicine / CT Scanners
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 19, 2021
Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Haag-Streit USA Inc.
FDA (openFDA device enforcement)
Reported May 19, 2021
REF CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
25 more products in this recall
FDA (openFDA device enforcement)
Reported May 19, 2021
Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part
High riskUsing this product could cause serious injury, illness or death — stop using it now.Infusion Pump Repair
FDA (openFDA device enforcement)
Reported May 19, 2021
Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medical Action Industries, Inc. 306
5 more products in this recall
FDA (openFDA device enforcement)
Reported May 19, 2021
VenaSeal Closure System
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Medtronic Inc.
FDA (openFDA device enforcement)
Reported May 19, 2021
Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Meridian Bioscience Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 19, 2021
AFT Straight Tube (3/4 Filled) - Human Allograph Tissue for treatment of surgically-created osseous defects or osseous…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Musculoskeletal Transplant Foundation, Inc.
FDA (openFDA device enforcement)
Reported May 19, 2021
Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Randox Laboratories Ltd.
FDA (openFDA device enforcement)
Reported May 19, 2021
Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: use in qualitative…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Remel Inc.
FDA (openFDA device enforcement)
Free recall alerts
Get alerted about new Medical device recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.
Related categories
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.