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 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)
Reported Oct 22, 2025
DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ConvaTec, Inc.
FDA (openFDA device enforcement)
Reported Oct 22, 2025
Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cook Medical Incorporated
FDA (openFDA device enforcement)
Reported Oct 22, 2025
Product: STA Liatest D-Di; REF: 00515;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Diagnostica Stago, Inc.
FDA (openFDA device enforcement)
Reported Oct 22, 2025
ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon Endo-Surgery Inc.
FDA (openFDA device enforcement)
Reported Oct 22, 2025
FERNO POWER X2 POWERED AMBULANCE COT, Model/Catalog Number: 0015816; FOR USE IN GROUND TRANSPORTATION AMBULANCES.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ferno-Washington Inc.
FDA (openFDA device enforcement)
Reported Oct 22, 2025
Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fisher & Paykel Healthcare, Ltd.
FDA (openFDA device enforcement)
Reported Oct 22, 2025
LOGIQ P10 series with software version R4.5.7 Model Number 5877534
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 22, 2025
Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Iantrek Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 22, 2025
The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Insulet Corporation
FDA (openFDA device enforcement)
Reported Oct 22, 2025
Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Kico Knee Innovation Company
FDA (openFDA device enforcement)
Reported Oct 22, 2025
XERF EFFECTOR 60. Electrosurgical unit.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Lutronic Corporation
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.