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 May 7, 2025
HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Leica Biosystems Melbourne Pty Ltd.
FDA (openFDA device enforcement)
Reported May 7, 2025
Medline Sterile Water, USP, 100mL, REF RDI30295
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
9 more products in this recall
FDA (openFDA device enforcement)
Reported May 7, 2025
Enhanced Verify Evaluation Handset (CFN HH90130FA)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
FDA (openFDA device enforcement)
Reported May 7, 2025
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported May 7, 2025
Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 7, 2025
Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Spectrum Medical Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 7, 2025
The Trimble RTS873 robotic total station is a solution designed for construction professionals seeking precision,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Trimble Ab
FDA (openFDA device enforcement)
Reported May 7, 2025
Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Waldemar Link GmbH & Co. KG (Mfg Site)
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 30, 2025
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
4 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 30, 2025
The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Molecular, Inc.
FDA (openFDA device enforcement)
Reported Apr 30, 2025
Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 30, 2025
Beckman Coulter DxI 9000 Access Immunoassay Analyzer
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Apr 30, 2025
BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-137; MINI 1HH-1FH-1HM, 169-101; MINI…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
FDA (openFDA device enforcement)
Reported Apr 30, 2025
Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Conavi Medical Inc.
FDA (openFDA device enforcement)
Reported Apr 30, 2025
Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in making…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Edge Biologicals Inc.
FDA (openFDA device enforcement)
Reported Apr 30, 2025
MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Globus Medical, Inc.
FDA (openFDA device enforcement)
Reported Apr 30, 2025
Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ihb Operations B.v.
FDA (openFDA device enforcement)
Reported Apr 30, 2025
The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
FDA (openFDA device enforcement)
Reported Apr 30, 2025
InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
FDA (openFDA device enforcement)
Reported Apr 30, 2025
NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Xomed, Inc.
FDA (openFDA device enforcement)
Reported Apr 30, 2025
Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 30, 2025
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rover…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Micro-X Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 30, 2025
Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.V.
FDA (openFDA device enforcement)
Reported Apr 30, 2025
Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
3 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.