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 21, 2023
Eye and Ear Dropper, Product Code 67082
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Apothecary Products, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 21, 2023
Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Neuromodulation Corporation
FDA (openFDA device enforcement)
Reported Jun 21, 2023
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Datascope Corp.
FDA (openFDA device enforcement)
Reported Jun 21, 2023
Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Galt Medical Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 21, 2023
Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
FDA (openFDA device enforcement)
Reported Jun 21, 2023
SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LumiraDx
FDA (openFDA device enforcement)
Reported Jun 21, 2023
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile EO, Rx Only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
12 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 21, 2023
'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.New Standard Device Inc.
FDA (openFDA device enforcement)
Reported Jun 21, 2023
NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device
High riskUsing this product could cause serious injury, illness or death — stop using it now.Noxbox Ltd.
FDA (openFDA device enforcement)
Reported Jun 21, 2023
Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ossur H / F
FDA (openFDA device enforcement)
Reported Jun 21, 2023
p-Chip Wand Reader
Moderate riskThis product could cause temporary or reversible health problems — stop using it.p-Chip Corporation
FDA (openFDA device enforcement)
Reported Jun 21, 2023
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Remote Diagnostic Technologies Ltd.
FDA (openFDA device enforcement)
Reported Jun 21, 2023
bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Vyaire Medical
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 14, 2023
Alinity i Anti-TPO Reagent Kit, List Number 09P3521
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Abbott Ireland Limited
FDA (openFDA device enforcement)
Reported Jun 14, 2023
AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Avanos Medical, Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 14, 2023
Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ages 0-6 years in…
High riskUsing this product could cause serious injury, illness or death — stop using it now.BearCare, Inc.
FDA (openFDA device enforcement)
Reported Jun 14, 2023
BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- Intended for the in vitro,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
FDA (openFDA device enforcement)
Reported Jun 14, 2023
The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BioReference Health, LLC
FDA (openFDA device enforcement)
Reported Jun 14, 2023
The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bolton Medical Inc.
FDA (openFDA device enforcement)
Reported Jun 14, 2023
Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, b) REF 51810, c) REF 51812, d) REF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.C.R. Bard Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 14, 2023
Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
FDA (openFDA device enforcement)
Reported Jun 14, 2023
DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Mitek, Inc., a Johnson & Johnson Co.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 14, 2023
Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.02,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DeRoyal Industries Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 14, 2023
Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Elekta, Inc.
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.