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 May 1, 2024
VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b)…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Biomerieux Inc.
FDA (openFDA device enforcement)
Reported May 1, 2024
Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
FDA (openFDA device enforcement)
Reported May 1, 2024
Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LP
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 1, 2024
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ebi, LLC
3 more products in this recall
FDA (openFDA device enforcement)
Reported May 1, 2024
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Electro Medical Systems SA
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 1, 2024
TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
11 more products in this recall
FDA (openFDA device enforcement)
Reported May 1, 2024
IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ion Beam Applications S.A.
FDA (openFDA device enforcement)
Reported May 1, 2024
Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Leica Biosystems Nussloch GmbH
FDA (openFDA device enforcement)
Reported May 1, 2024
Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Parker Laboratories, Inc.
FDA (openFDA device enforcement)
Reported May 1, 2024
Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS): 1. APC (Schneider Electric IT…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
FDA (openFDA device enforcement)
Reported May 1, 2024
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Quidel Corporation
1 more product in this recall
FDA (openFDA device enforcement)
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)
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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.