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 Nov 8, 2023
Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708), Intelligent…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Asensus Surgical Inc.
FDA (openFDA device enforcement)
Reported Nov 8, 2023
HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported Nov 8, 2023
Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cepheid
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 8, 2023
Coapt Dome Electrode, Gen2 system, cutaneous electrode
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Coapt LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 8, 2023
Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplasty
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Corin Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 8, 2023
Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cosmedent, Inc.
FDA (openFDA device enforcement)
Reported Nov 8, 2023
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
High riskUsing this product could cause serious injury, illness or death — stop using it now.Covidien
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 8, 2023
Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 printed on outer label, inner label and IFU,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
FDA (openFDA device enforcement)
Reported Nov 8, 2023
LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
FDA (openFDA device enforcement)
Reported Nov 8, 2023
AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microvention Inc.
FDA (openFDA device enforcement)
Reported Nov 8, 2023
Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nova Biomedical Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 8, 2023
Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrogenic intravenous fluid administration sets…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Quest Medical, Inc.
FDA (openFDA device enforcement)
Reported Nov 8, 2023
RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Randox Laboratories Ltd.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 8, 2023
RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
FDA (openFDA device enforcement)
Reported Nov 8, 2023
Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 8, 2023
Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
FDA (openFDA device enforcement)
Reported Nov 1, 2023
TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Acclarent, Inc.
FDA (openFDA device enforcement)
Reported Nov 1, 2023
General Pack, REF BBGP31C
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Contract Systems, Inc.
11 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 1, 2023
8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
High riskUsing this product could cause serious injury, illness or death — stop using it now.B. Braun Medical, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 1, 2023
Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cardinal Health 200, LLC
5 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 1, 2023
OPMI LUMERA 300, REF 6137
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carl Zeiss Suzhou Co., Ltd.
FDA (openFDA device enforcement)
Reported Nov 1, 2023
Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Empatica Srl
FDA (openFDA device enforcement)
Reported Nov 1, 2023
Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Processing System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
4 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 1, 2023
SOZO Bilateral Arm L-Dex Software
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Impedimed Limited
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.