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 21, 2026Updated Oct 26, 2026
NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
FDA (openFDA device enforcement)
Reported Oct 21, 2026Updated Oct 26, 2026
Brand Name: IOMAX Product Name: IOMAX Cortical Module Model/Catalog Number: 190296-200 UDI-DI code: 00840067100653…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cadwell Industries Inc.
FDA (openFDA device enforcement)
Reported Oct 21, 2026Updated Oct 26, 2026
Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Incorporated
FDA (openFDA device enforcement)
Reported Oct 21, 2026Updated Oct 26, 2026
PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, LLC
FDA (openFDA device enforcement)
Reported Oct 21, 2026Updated Oct 26, 2026
Power F2 Powered Fastening System, Power F2, Item No. 0567093 used with Power X2 Stretchers, Power X2, Item No. 0015816…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ferno-Washington Inc.
FDA (openFDA device enforcement)
Reported Oct 21, 2026Updated Oct 26, 2026
Vinyl Instrument Guards, labeled as: 1) VENTED INSTRUMENT GUARD 1/16 X 3/4H - WHITE, Model Number 09-1-011; 2) WHITE…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Healthmark Industries Co., Inc.
FDA (openFDA device enforcement)
Reported Oct 21, 2026Updated Oct 26, 2026
TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 21, 2026Updated Oct 26, 2026
REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm
Moderate riskThis product could cause temporary or reversible health problems — stop using it.In2bones USA, LLC
FDA (openFDA device enforcement)
Reported Oct 21, 2026Updated Oct 26, 2026
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)
High riskUsing this product could cause serious injury, illness or death — stop using it now.Instrumentation Laboratory
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 21, 2026Updated Oct 26, 2026
FORWARD Gunshot Wound Kit; Model: AFT-GSW;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integrated Medcraft LLC
FDA (openFDA device enforcement)
Reported Oct 21, 2026Updated Oct 26, 2026
IntelePACS, InteleConnect Portal/Tech Portal Versions PACS-5-1-1-R102, PACS-5-2-1-R93, PACS-5-3-1-R83 through R128,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intelerad Medical Systems Incorporated
FDA (openFDA device enforcement)
Reported Oct 21, 2026Updated Oct 26, 2026
JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Jenavalve Technology Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 21, 2026Updated Oct 26, 2026
LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Magellan Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Oct 21, 2026Updated Oct 26, 2026
1) Product Name AUD OPEN HEART PACK, Medline Kit Number/SKU DYNJ22052I; 2) Product Name AV SHUNT PACK-MARYVIEW, Medline…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medline Industries, LP
10 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 21, 2026Updated Oct 26, 2026
Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 21, 2026Updated Oct 26, 2026
Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delivery System, Standard for use with the SCOUT…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
FDA (openFDA device enforcement)
Reported Oct 21, 2026Updated Oct 26, 2026
MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF: OPRO-101; MAS Omni IMMUNETM PRO Liquid…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microgenics Corporation
FDA (openFDA device enforcement)
Reported Oct 21, 2026Updated Oct 26, 2026
NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81-01000-200. Affects the below…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Neuronetics, Inc.
FDA (openFDA device enforcement)
Reported Oct 21, 2026Updated Oct 26, 2026
The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists, nurses, physicians and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Radiometer Medical ApS
FDA (openFDA device enforcement)
Reported Oct 21, 2026Updated Oct 26, 2026
Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack (10 pk), Item Number 670272-KIT
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sarnova HC, LLC
FDA (openFDA device enforcement)
Reported Oct 21, 2026Updated Oct 26, 2026
iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.SI-BONE, Inc.
FDA (openFDA device enforcement)
Reported Oct 21, 2026Updated Oct 26, 2026
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
FDA (openFDA device enforcement)
Reported Oct 21, 2026Updated Oct 26, 2026
Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006 Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.W L Gore & Associates, Inc.
FDA (openFDA device enforcement)
Reported Oct 14, 2026Updated Oct 20, 2026
DAVINCI TRUCUSTOM BUNDLE; Model/Item Number (Kit): 1. SAMM064-27, 2. SAMM064-28;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.AVID Medical, Inc.
7 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.