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 Oct 29, 2025
BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 29, 2025
BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
FDA (openFDA device enforcement)
Reported Oct 29, 2025
Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E ENFit"…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
5 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 29, 2025
Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS200401, OS328017, OS200020L, OS200025L,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CPM Medical Consultants, LLC.
FDA (openFDA device enforcement)
Reported Oct 29, 2025
Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ge Medical Systems Israel, Functional Imaging
13 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 29, 2025
MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
FDA (openFDA device enforcement)
Reported Oct 29, 2025
HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J
Moderate riskThis product could cause temporary or reversible health problems — stop using it.HeartSine Technologies Ltd.
FDA (openFDA device enforcement)
Reported Oct 29, 2025
One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g The Lancing…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Home Health US, Incorporated
FDA (openFDA device enforcement)
Reported Oct 29, 2025
IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm)…
High riskUsing this product could cause serious injury, illness or death — stop using it now.ICU Medical, Inc.
FDA (openFDA device enforcement)
Reported Oct 29, 2025
Artegraft¿ Collagen Vascular Graft; REF: AG1015;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LeMaitre Vascular, Inc.
FDA (openFDA device enforcement)
Reported Oct 29, 2025
Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medline Industries, LP
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 29, 2025
Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
FDA (openFDA device enforcement)
Reported Oct 29, 2025
Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sedecal Sa
45 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 29, 2025
LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 29, 2025
t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tandem Diabetes Care, Inc.
FDA (openFDA device enforcement)
Reported Oct 29, 2025
iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Theken Companies LLC
FDA (openFDA device enforcement)
Reported Oct 29, 2025
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 530 MD, Rx Only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.UIH Technologies LLC
8 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 29, 2025
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wipro GE Healthcare Private Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 22, 2025
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abbott
4 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 22, 2025
Basic Biopsy Tray, Item Number NMBP44L
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Contract Systems Inc.
17 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 22, 2025
CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
15 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 22, 2025
BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BioPro, Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 22, 2025
ACCOLADE SR SL (Model L300)
High riskUsing this product could cause serious injury, illness or death — stop using it now.Boston Scientific Corporation
33 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 22, 2025
Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Contego Medical 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.