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 Sep 15, 2021
Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ion Beam Applications S.A.
FDA (openFDA device enforcement)
Reported Sep 15, 2021
Pipeline Flex Embolization Device
High riskUsing this product could cause serious injury, illness or death — stop using it now.Micro Therapeutics Inc.,
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 15, 2021
MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 cm length); MIA-9090S (90 cm length), and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mivi Neuroscience Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 15, 2021
Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01) 00843685100012 The Nihon Kohden NKV-550 Series…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nihon Kohden Orangemed, Inc.
FDA (openFDA device enforcement)
Reported Sep 15, 2021
Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Sep 15, 2021
Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
12 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 15, 2021
Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 15, 2021
NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 8, 2021
Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aspen Surgical Products, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 8, 2021
Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 8, 2021
DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardiovascular Systems Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 8, 2021
Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Clarus Medical, LLC
FDA (openFDA device enforcement)
Reported Sep 8, 2021
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien, LP
17 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 8, 2021
TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 8, 2021
Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Elekta Inc.
FDA (openFDA device enforcement)
Reported Sep 8, 2021
Steripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/adapter assembly may be used for the access…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Magnolia Medical Technologies, Inc.
FDA (openFDA device enforcement)
Reported Sep 8, 2021
Merge Hemo, Software packages 10.2, 10.3, and 10.4
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
FDA (openFDA device enforcement)
Reported Sep 8, 2021
MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
Moderate riskThis product could cause temporary or reversible health problems — stop using it.My01, Inc.
FDA (openFDA device enforcement)
Reported Sep 8, 2021
Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Sep 8, 2021
CombiDiagnost R90 Software Version R1.0 and R1.1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems GmbH, DMC
FDA (openFDA device enforcement)
Reported Sep 8, 2021
Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Sep 8, 2021
smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
FDA (openFDA device enforcement)
Reported Sep 8, 2021
EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Thera Test Laboratories, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 8, 2021
CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-CoV-2 Antigen Qualitative detection of the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Versea Diagnostics LLC
3 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.