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 Dec 20, 2023
Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported Dec 20, 2023
SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bebig Isotopentechnik GmbH
FDA (openFDA device enforcement)
Reported Dec 20, 2023
The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BioReference Health, LLC
FDA (openFDA device enforcement)
Reported Dec 20, 2023
Sensica Urine Output System, Catalog Number SCCS1002
Moderate riskThis product could cause temporary or reversible health problems — stop using it.C.R. Bard Inc.
FDA (openFDA device enforcement)
Reported Dec 20, 2023
Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Change Healthcare Canada Company
FDA (openFDA device enforcement)
Reported Dec 20, 2023
RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Encore Medical, LP
FDA (openFDA device enforcement)
Reported Dec 20, 2023
The System is designed as a modular system with components that include an Overhead Tube Suspension with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Hangwei Medical Systems, Co. Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 20, 2023
CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP)…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Integra LifeSciences Corp.
FDA (openFDA device enforcement)
Reported Dec 20, 2023
PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Limacorporate S.p.A
FDA (openFDA device enforcement)
Reported Dec 20, 2023
CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Medical Systems USA
FDA (openFDA device enforcement)
Reported Dec 20, 2023
STERILE PVP SOLUTION, REF DYNDA1907
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 Dec 20, 2023
Medtronic SynchroMed, Model A10
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
FDA (openFDA device enforcement)
Reported Dec 20, 2023
Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Meridian Bioscience Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 20, 2023
TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Dec 20, 2023
VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 20, 2023
Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR)…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Philips North America LLC
FDA (openFDA device enforcement)
Reported Dec 20, 2023
Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with XBraid S…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Riverpoint Medical, LLC
FDA (openFDA device enforcement)
Reported Dec 20, 2023
ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Dec 20, 2023
Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Spectranetics Corporation
FDA (openFDA device enforcement)
Reported Dec 13, 2023
Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abiomed, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 13, 2023
Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Atrium Medical Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 13, 2023
Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Auris Health Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 13, 2023
Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 362032 15…
High riskUsing this product could cause serious injury, illness or death — stop using it now.B. Braun Medical, Inc.
FDA (openFDA device enforcement)
Reported Dec 13, 2023
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BioFire Diagnostics, 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.