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 Feb 12, 2025
PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 12, 2025
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
FDA (openFDA device enforcement)
Reported Feb 12, 2025
Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
3 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 12, 2025
The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hologic, Inc.
FDA (openFDA device enforcement)
Reported Feb 12, 2025
SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LivaNova USA, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 12, 2025
UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medicrea International
FDA (openFDA device enforcement)
Reported Feb 12, 2025
NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-ENU-USL GSP30-0R-96-ENU-USL GSP30-ARA-INTL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Neilmed Pharmaceuticals Inc.
FDA (openFDA device enforcement)
Reported Feb 12, 2025
Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.New Medical Technologies GmbH
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 12, 2025
. Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nobel Biocare
FDA (openFDA device enforcement)
Reported Feb 12, 2025
Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Oxoid Limited
FDA (openFDA device enforcement)
Reported Feb 12, 2025
Allura CV20 System Code: 722031
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
18 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 12, 2025
IntelliBridge EC10 Module. Model Number: 865115
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
4 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 12, 2025
LIFEPAK 35 ECG cable REF 11111-000041
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Physio-Control, Inc.
FDA (openFDA device enforcement)
Reported Feb 12, 2025
regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to…
High riskUsing this product could cause serious injury, illness or death — stop using it now.ROi CPS LLC
FDA (openFDA device enforcement)
Reported Feb 12, 2025
Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sysmex America, Inc.
FDA (openFDA device enforcement)
Reported Feb 12, 2025
Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK AP120253PK AP120313PK AP125213PK AP125253PK…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.US Endodontics, LLC
FDA (openFDA device enforcement)
Reported Feb 5, 2025
CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Accuray Incorporated
FDA (openFDA device enforcement)
Reported Feb 5, 2025
Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alphatec Spine, Inc.
FDA (openFDA device enforcement)
Reported Feb 5, 2025
Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
FDA (openFDA device enforcement)
Reported Feb 5, 2025
AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
13 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 5, 2025
BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
FDA (openFDA device enforcement)
Reported Feb 5, 2025
Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Draeger Medical Systems, Inc.
FDA (openFDA device enforcement)
Reported Feb 5, 2025
HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory
FDA (openFDA device enforcement)
Reported Feb 5, 2025
KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
13 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.