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 May 1, 2024
Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Route 92 Medical Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported May 1, 2024
Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner RDX…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Seaspine Orthopedics Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 1, 2024
ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 1, 2024
LightStrike Blackout Curtains, Part numbers; 610-00008, 610-00009, 610-00019, 610-00020, and 610-00024, used with the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.XENEX Disinfection Services Inc.
FDA (openFDA device enforcement)
Reported May 1, 2024
NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
FDA (openFDA device enforcement)
Reported Apr 24, 2024
Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Actim Oy
FDA (openFDA device enforcement)
Reported Apr 24, 2024
CryoValve SG Cryopreserved Pulmonary Human Heart Valve
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Artivion, Inc.
FDA (openFDA device enforcement)
Reported Apr 24, 2024
Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 24, 2024
Identity Imprint PS Tibial Tray Size 4: Lot 540287
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Conformis, Inc.
FDA (openFDA device enforcement)
Reported Apr 24, 2024
Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN): 1) DCHN-18-10.0…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Incorporated
7 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 24, 2024
Dr¿ger Perseus A500 Anesthesia Workstation
High riskUsing this product could cause serious injury, illness or death — stop using it now.Draeger Medical, Inc.
FDA (openFDA device enforcement)
Reported Apr 24, 2024
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Elekta Instrument AB
FDA (openFDA device enforcement)
Reported Apr 24, 2024
STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
FDA (openFDA device enforcement)
Reported Apr 24, 2024
Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Masimo Corporation
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 24, 2024
Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
High riskUsing this product could cause serious injury, illness or death — stop using it now.Outset Medical, Inc.
FDA (openFDA device enforcement)
Reported Apr 24, 2024
Achieva 1.5T, Magnetic Resonance System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
40 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 24, 2024
Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
High riskUsing this product could cause serious injury, illness or death — stop using it now.Philips Respironics, Inc.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 24, 2024
Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Randox Laboratories Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 24, 2024
SW Bari Lift & Transfer, Model Number 38060000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raye's Inc.
FDA (openFDA device enforcement)
Reported Apr 24, 2024
Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Apr 24, 2024
Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling-…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Apr 24, 2024
RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew Medical, Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 24, 2024
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 24, 2024
AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
High riskUsing this product could cause serious injury, illness or death — stop using it now.SonarMed Inc.
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.