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.
13,791 stored notices, reported between Jun 20, 2012 and Oct 28, 2026. Newest first.
Reported Sep 23, 2026Updated Sep 29, 2026
Halyard IV START KIT NON-STERILE REF: KRIV26-02
High riskUsing this product could cause serious injury, illness or death — stop using it now.AVID Medical, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 23, 2026Updated Sep 29, 2026
Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605150; Power-Trialysis Short-Term Straight Dialysis…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Bard Access Systems, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 23, 2026Updated Sep 29, 2026
MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bayer Medical Care, Inc.
FDA (openFDA device enforcement)
Reported Sep 23, 2026Updated Sep 29, 2026
BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump Infusion Set, 15 Micron Filter,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Bd Switzerland Sarl
FDA (openFDA device enforcement)
Reported Sep 23, 2026Updated Sep 29, 2026
Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
FDA (openFDA device enforcement)
Reported Sep 23, 2026Updated Sep 29, 2026
Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Datex-Ohmeda, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 23, 2026Updated Sep 29, 2026
EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100
Moderate riskThis product could cause temporary or reversible health problems — stop using it.embecta Medical II LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 23, 2026Updated Sep 29, 2026
Reign Medical Clench Staple System (Compression), Description/REF: 9mm x 7mm/152-30907; 11mm x 10mm/152-31110; 15mm x…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.F & A Foundation
FDA (openFDA device enforcement)
Reported Sep 23, 2026Updated Sep 29, 2026
Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
5 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 23, 2026Updated Sep 29, 2026
Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product code STU CSCS V3 MAI800…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems Information Technologies Inc.
FDA (openFDA device enforcement)
Reported Sep 23, 2026Updated Sep 29, 2026
Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Happiest Baby, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 23, 2026Updated Sep 29, 2026
AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500 Orthopaedic implant components manufactured from…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 23, 2026Updated Sep 29, 2026
Plum administration sets
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 23, 2026Updated Sep 29, 2026
Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS);
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiopulmonary GmbH
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 23, 2026Updated Sep 29, 2026
Blood Culture Collection Venipuncture Kit 20/Cs, REF: 77451; Blood Culture Kit 20/Cs, REF: 81834B; Blood Culture…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medical Action Industries, Inc. 306
FDA (openFDA device enforcement)
Reported Sep 23, 2026Updated Oct 8, 2026
Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199A
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medline Industries, LP
10 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 23, 2026Updated Sep 29, 2026
Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mirion Technologies (Capintec), Inc.
FDA (openFDA device enforcement)
Reported Sep 23, 2026Updated Sep 29, 2026
StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Nova Biomedical Corporation
4 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 23, 2026Updated Sep 29, 2026
NOxBOXi Nitric Oxide Delivery System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Noxbox Ltd.
FDA (openFDA device enforcement)
Reported Sep 23, 2026Updated Sep 29, 2026
Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nuclein LLC
FDA (openFDA device enforcement)
Reported Sep 23, 2026Updated Sep 29, 2026
Philips Patient Information Center iX REF:866389
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 23, 2026Updated Sep 29, 2026
Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Pi Cardia Ltd.
FDA (openFDA device enforcement)
Reported Sep 23, 2026Updated Sep 29, 2026
Brand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number: S070031.520; Software Version: 3.1.18;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ptw Freiburg
FDA (openFDA device enforcement)
Reported Sep 23, 2026Updated Sep 29, 2026
Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
Moderate riskThis product could cause temporary or reversible health problems — stop using it.restor3d 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.