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 Jul 10, 2024
EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MicroPort Orthopedics Inc.
FDA (openFDA device enforcement)
Reported Jul 10, 2024
Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nalu Medical, Inc.
FDA (openFDA device enforcement)
Reported Jul 10, 2024
EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Jul 10, 2024
VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Ortho-Clinical Diagnostics, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 10, 2024
Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
FDA (openFDA device enforcement)
Reported Jul 10, 2024
Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: MR2102035 Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Seaspine Orthopedics Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 10, 2024
ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens AG/Siemens Healthcare GmbH
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 10, 2024
The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with commercially…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 10, 2024
Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
FDA (openFDA device enforcement)
Reported Jul 10, 2024
WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic surgeries.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.WOM World Of Medicine AG
FDA (openFDA device enforcement)
Reported Jul 10, 2024
Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zyno Medical LLC
FDA (openFDA device enforcement)
Reported Jul 3, 2024
Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aspen Surgical
FDA (openFDA device enforcement)
Reported Jul 3, 2024
Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported Jul 3, 2024
RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
FDA (openFDA device enforcement)
Reported Jul 3, 2024
CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Centers For Disease Control and Prevention
FDA (openFDA device enforcement)
Reported Jul 3, 2024
Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Incorporated
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 3, 2024
Titan Scaler Tip - Perio Model/Catalog Number: 261669 The scaler tip is used with an air drive scaler for subgingival…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dental EZ Group Star Dental Division
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 3, 2024
Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Draeger Medical Systems, Inc.
FDA (openFDA device enforcement)
Reported Jul 3, 2024
CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c) 5865770-01054142; d) 5865770-01054696; e)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare Finland Oy
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 3, 2024
Inspire Model 3028, IV Implantable Pulse Generator
High riskUsing this product could cause serious injury, illness or death — stop using it now.Inspire Medical Systems Inc.
FDA (openFDA device enforcement)
Reported Jul 3, 2024
CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
FDA (openFDA device enforcement)
Reported Jul 3, 2024
The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 3, 2024
COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
22 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 3, 2024
Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
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.