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 Oct 28, 2026Updated Nov 2, 2026
Amplatzer Amulet Left Atrial Appendage Occluder Model Numbers 1. 9-ACP2-007-016 2. 9-ACP2-007-018 3. 9-ACP2-007-020 4.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott
FDA (openFDA device enforcement)
Reported Oct 28, 2026Updated Nov 2, 2026
Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH30.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.AVID Medical, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 28, 2026Updated Nov 2, 2026
PNE Lead Implant Kit REF: 1701
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Axonics, Inc.
FDA (openFDA device enforcement)
Reported Oct 28, 2026Updated Nov 2, 2026
B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B Braun Medical Inc.
FDA (openFDA device enforcement)
Reported Oct 28, 2026Updated Nov 2, 2026
ROTOR ASSY-SW40, Reference Number 331302, when the rotors are installed in the following centrifuges: Optima XPN-100…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Oct 28, 2026Updated Nov 2, 2026
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/105; Material Number: M001195290
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Cork, Ltd.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 28, 2026Updated Nov 2, 2026
Generic Name: Softmed Breathables Advanced Toric (fanfilcon A) Soft (Hydrophilic) Contact Lens; Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CooperVision, Inc.
FDA (openFDA device enforcement)
Reported Oct 28, 2026Updated Nov 2, 2026
Brand Name: VACUETTE Product Name: LH Lithium Heparin Separator Model/Catalog Number: 454008P Product Description:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Greiner Bio-One North America, Inc.
FDA (openFDA device enforcement)
Reported Oct 28, 2026Updated Nov 2, 2026
Ion Torrent Genexus Dx with software, Catalog: A40003539, which supports the Ion Torrent Genexus Dx Integrated Sequencer
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Life Technologies Holdings Pte Ltd.
FDA (openFDA device enforcement)
Reported Oct 28, 2026Updated Nov 2, 2026
MEDLINE DRAPE C-SEC FEN CLEAR SCRN WIRE, Medline Product Number/SKU DYNJP6106
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medline Industries, LP
6 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 28, 2026Updated Nov 2, 2026
CareLink Clinic, REF: MMT-7350
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 28, 2026Updated Nov 2, 2026
Medtronic NDI Passive Spheres REF: 8801075, Sterile EO, 5/Tray 12 Pk., Rxonly
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 28, 2026Updated Nov 2, 2026
InterStim SureScan MRI Leads 978A1 & 978B1: LEAD 978A128 ISTM MICRO 28CM SSMRI TINED 978A128 LEAD 978A133 ISTM MICRO…
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 Oct 28, 2026Updated Nov 2, 2026
Philips Smart-hopping 2.0 AP 1.4 GHz; Product/Model Number: 867216;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
FDA (openFDA device enforcement)
Reported Oct 28, 2026Updated Nov 2, 2026
Philips Lumify Diagnostic Ultrasound System
High riskUsing this product could cause serious injury, illness or death — stop using it now.Philips Ultrasound, LLC
FDA (openFDA device enforcement)
Reported Oct 28, 2026Updated Nov 2, 2026
Generic Name: restor3d MTP Implant Generic Name: MTP Implant Model/Catalog Number: 1103-161620 Software Version: None…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.restor3d Inc.
FDA (openFDA device enforcement)
Reported Oct 28, 2026Updated Nov 2, 2026
Xact mole marker for mammography Model/Catalog Number: M15RM
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Solstice Corporation
FDA (openFDA device enforcement)
Reported Oct 28, 2026Updated Nov 2, 2026
Techno-Path Multichem AE Unassayed Level 2 REF: AE622X
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Techno-Path Manufacturing Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 28, 2026Updated Nov 2, 2026
Think Surgical Square Driver REF: 109126
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Think Surgical, Inc.
FDA (openFDA device enforcement)
Reported Oct 28, 2026Updated Nov 2, 2026
VOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for ventilatory support.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Ventec Life Systems, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 21, 2026Updated Oct 26, 2026
Likorall Overhead Lifts Product Code: 3121001 Product Description: LIKORALL 200 Product Code: 3122005 Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported Oct 21, 2026Updated Oct 26, 2026
DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 21, 2026Updated Oct 26, 2026
BD Phoenix Panel NMIC-312. Catalog Number: 449082.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
FDA (openFDA device enforcement)
Reported Oct 21, 2026Updated Nov 2, 2026
Generic Name: FilmArray¿ Pneumonia Panel plus Generic Name: FilmArray¿ Pneumonia Panel plus Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BioFire Diagnostics, LLC
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.