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 Jul 20, 2022
MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
FDA (openFDA device enforcement)
Reported Jul 20, 2022
Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Draeger Medical Systems, Inc.
FDA (openFDA device enforcement)
Reported Jul 20, 2022
AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 -…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 20, 2022
HAMILTON-H900 Humidifier, Models: 950001, 950004
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Hamilton Medical AG
FDA (openFDA device enforcement)
Reported Jul 20, 2022
Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Invacare Corporation
FDA (openFDA device enforcement)
Reported Jul 20, 2022
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Isopure Corp.
FDA (openFDA device enforcement)
Reported Jul 20, 2022
Ivenix Infusion System (IIS)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ivenix, Inc.
FDA (openFDA device enforcement)
Reported Jul 20, 2022
MiniMed 620G Insulin Pump (O.U.S. version)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 20, 2022
Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Jul 20, 2022
ProxiDiagnost N90. radiography and fluoroscopy system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems DMC GmbH
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 20, 2022
ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Science & Bio Materials
FDA (openFDA device enforcement)
Reported Jul 20, 2022
epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics Inc.
FDA (openFDA device enforcement)
Reported Jul 20, 2022
Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Spectranetics Corporation
FDA (openFDA device enforcement)
Reported Jul 20, 2022
Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554; Peak SE…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ultradent Products, Inc.
FDA (openFDA device enforcement)
Reported Jul 20, 2022
Ventana HE 600 System, automated slide preparer, for use in laboratories.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ventana Medical Systems Inc.
FDA (openFDA device enforcement)
Reported Jul 20, 2022
Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Waldemar Link GmbH & Co. KG (Mfg Site)
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 20, 2022
Wright EVOLVE TRIAD Plate Cutter, REF 49510120
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wright Medical Technology, Inc.
FDA (openFDA device enforcement)
Reported Jul 20, 2022
CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zeltiq Aesthetics, Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 13, 2022
Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott
FDA (openFDA device enforcement)
Reported Jul 13, 2022
Clean Catch Urine Kit NS 178489, AHMU58A
High riskUsing this product could cause serious injury, illness or death — stop using it now.American Contract Systems, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 13, 2022
Omnera 400T Digital Radiographic System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Arcoma AB
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 13, 2022
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Chromsystems Instruments & Chemicals GmbH
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 13, 2022
Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Covidien LLC
8 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 13, 2022
EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien, LP
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.