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 Aug 16, 2023
HoverMatt, 39" W x 78" L, REF: HM39SPU-B
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
FDA (openFDA device enforcement)
Reported Aug 16, 2023
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for patients with Mobility-limiting diseases,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Waldemar Link GmbH & Co. KG (Mfg Site)
11 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 9, 2023
Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abiomed, Inc.
FDA (openFDA device enforcement)
Reported Aug 9, 2023
Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien, LLC
FDA (openFDA device enforcement)
Reported Aug 9, 2023
Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Creganna Medical Devices
FDA (openFDA device enforcement)
Reported Aug 9, 2023
OEC Flexiview 8800 Systems with 9-inch Image Intensifier
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE OEC Medical Systems, Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 9, 2023
NanoZoomer S360MD Slide scanner system-automated system for creating, viewing, and managing digital slides. The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hamamatsu Corporation
FDA (openFDA device enforcement)
Reported Aug 9, 2023
VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Johnson & Johnson Surgical Vision, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 9, 2023
ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chest…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
3 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 9, 2023
ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Materialise N.V.
FDA (openFDA device enforcement)
Reported Aug 9, 2023
Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a. COVER, PROBE, W/GEL AND BANDS,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
49 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 9, 2023
MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Megadyne Medical Products, Inc.
FDA (openFDA device enforcement)
Reported Aug 9, 2023
Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape, 91 cm x 51 cm (36 in x 20 in), Model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microtek Medical Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 9, 2023
NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.NeuMoDx Molecular Inc.
FDA (openFDA device enforcement)
Reported Aug 9, 2023
Always-On Tip Tracked Instruments (SPiN Drive¿ instruments) Brush, 15mm L, 1.8mm OD Intended for use in clinical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
7 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 9, 2023
Allura Xper FD10 and FD20. X-ray Imaging System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 9, 2023
Incisive CT-Computed Tomography X-Ray System Model: 728143
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
3 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 9, 2023
STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Scican Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 9, 2023
Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Shimadzu Corporation Medical Systems Division
FDA (openFDA device enforcement)
Reported Aug 9, 2023
The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Aug 9, 2023
Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; Fusion Lithotripsy Extraction Baskets are…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wilson-Cook Medical Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 9, 2023
Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 159 mm Length-Indicated for temporary…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
FDA (openFDA device enforcement)
Reported Aug 2, 2023
Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Argon Medical Devices, Inc.
FDA (openFDA device enforcement)
Reported Aug 2, 2023
Ringed DxI Reaction Vessels (RVs)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, 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.