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 Aug 31, 2022
Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
FDA (openFDA device enforcement)
Reported Aug 31, 2022
DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124; (2) DeRoyal Limb Holder, Ankle,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DeRoyal Industries Inc.
FDA (openFDA device enforcement)
Reported Aug 31, 2022
(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
FDA (openFDA device enforcement)
Reported Aug 31, 2022
Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Getinge USA Sales Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 31, 2022
HAMILTON-C6 Intensive Care Ventilator, REF: 160021
High riskUsing this product could cause serious injury, illness or death — stop using it now.Hamilton Medical AG
FDA (openFDA device enforcement)
Reported Aug 31, 2022
INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Intera Oncology, Inc.
FDA (openFDA device enforcement)
Reported Aug 31, 2022
ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Materialise USA LLC
FDA (openFDA device enforcement)
Reported Aug 31, 2022
a. Rapid Test Kit Coag-Sense Professional Blood Coagulation Test Prothrombin Time Test (PT/INR) Whole Blood Sample 50…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mckesson Medical-Surgical Inc. Corporate Office
54 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 31, 2022
Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 31, 2022
HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mizuho OSI
FDA (openFDA device enforcement)
Reported Aug 31, 2022
Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nobel Biocare
FDA (openFDA device enforcement)
Reported Aug 31, 2022
SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Safe Orthopaedics LLC
FDA (openFDA device enforcement)
Reported Aug 31, 2022
NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Synapse Biomedical Inc.
FDA (openFDA device enforcement)
Reported Aug 31, 2022
Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wright Medical Technology, Inc.
FDA (openFDA device enforcement)
Reported Aug 24, 2022
The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Molecular, Inc.
FDA (openFDA device enforcement)
Reported Aug 24, 2022
(1) CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads 5 in. x 9 in. per box, ASO Item No. 781083, SKU…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aso LLC
FDA (openFDA device enforcement)
Reported Aug 24, 2022
BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Drug Transfer Device (CSTD) that…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
FDA (openFDA device enforcement)
Reported Aug 24, 2022
CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU-ID 900260
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Family Dollar Stores, Llc.
21 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 24, 2022
HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
High riskUsing this product could cause serious injury, illness or death — stop using it now.Heartware, Inc.
FDA (openFDA device enforcement)
Reported Aug 24, 2022
ARIES SARS-CoV-2 Assay
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Luminex Corporation
FDA (openFDA device enforcement)
Reported Aug 24, 2022
Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Micro Therapeutics, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 24, 2022
Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Myolyn Inc.
FDA (openFDA device enforcement)
Reported Aug 24, 2022
AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Combo 64 6623974; AXIOM Sensis,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Aug 24, 2022
NARMD MEDICAL DEPOT Scissors Iris Curved 4.5", Part Number ZZ-0697
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stradis Medical, LLC dba Stradis Healthcare
2 more products 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.