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 8, 2025
Change Healthcare Radiology Solutions software version 14.2.2
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Change Healthcare Canada Company
FDA (openFDA device enforcement)
Reported Oct 8, 2025
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Draeger, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 8, 2025
Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Getinge Disinfection Ab
FDA (openFDA device enforcement)
Reported Oct 8, 2025
1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
FDA (openFDA device enforcement)
Reported Oct 8, 2025
Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LeMaitre Vascular, Inc.
FDA (openFDA device enforcement)
Reported Oct 8, 2025
Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MedicalCommunications GmbH
FDA (openFDA device enforcement)
Reported Oct 8, 2025
Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Number:…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medline Industries, LP
7 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 8, 2025
Medtronic, Simplera Sensor, REF: MMT-5100JD1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
FDA (openFDA device enforcement)
Reported Oct 8, 2025
JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.North American Rescue LLC.
FDA (openFDA device enforcement)
Reported Oct 8, 2025
NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Northeast Scientific Inc.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 8, 2025
Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
14 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 8, 2025
IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.S.I.N. Implant System Ltda
FDA (openFDA device enforcement)
Reported Oct 8, 2025
Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Schiller, Ag
FDA (openFDA device enforcement)
Reported Oct 8, 2025
Biograph mMR. Model Number: 10433372.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Siemens Medical Solutions USA, Inc.
14 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 8, 2025
GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.W L Gore & Associates, Inc.
FDA (openFDA device enforcement)
Reported Oct 8, 2025
ZAP-X Radiosurgery System, Model: 300150
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zap Surgical Systems
FDA (openFDA device enforcement)
Reported Oct 1, 2025
Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abiomed, Inc.
FDA (openFDA device enforcement)
Reported Oct 1, 2025
Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported Oct 1, 2025
FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biofire Defense
FDA (openFDA device enforcement)
Reported Oct 1, 2025
Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
FDA (openFDA device enforcement)
Reported Oct 1, 2025
Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
FDA (openFDA device enforcement)
Reported Oct 1, 2025
MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CooperVision, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 1, 2025
STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, LLC
FDA (openFDA device enforcement)
Reported Oct 1, 2025
Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
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.