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 24, 2023
YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Surgical Innovations Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 24, 2023
Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 4000; for sealing residual oozing of tissue…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex LLC
FDA (openFDA device enforcement)
Reported May 17, 2023
Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Implant Systems LLC
FDA (openFDA device enforcement)
Reported May 17, 2023
Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bard Peripheral Vascular Inc.
FDA (openFDA device enforcement)
Reported May 17, 2023
BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bio-Rad Laboratories, Inc.
FDA (openFDA device enforcement)
Reported May 17, 2023
BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower), REF: 352; BD Pyxis…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
FDA (openFDA device enforcement)
Reported May 17, 2023
Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cook Incorporated
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 17, 2023
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cordis US Corp.
13 more products in this recall
FDA (openFDA device enforcement)
Reported May 17, 2023
STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Diagnostica Stago, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 17, 2023
PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
FDA (openFDA device enforcement)
Reported May 17, 2023
Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
FDA (openFDA device enforcement)
Reported May 17, 2023
COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
FDA (openFDA device enforcement)
Reported May 17, 2023
M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
Moderate riskThis product could cause temporary or reversible health problems — stop using it.New Wave Endo-Surgical, Corp.
FDA (openFDA device enforcement)
Reported May 17, 2023
TDHisto/Cyto - A software product used for managing medical information in the field of laboratories performing…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Technidata S.A.
FDA (openFDA device enforcement)
Reported May 10, 2023
WALGREENS BANDAGES, item number 196568, 110 CT VALUE PACK, 24 BOXES/MASTER (shipping container), Walgreens Family Pack…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aso LLC
FDA (openFDA device enforcement)
Reported May 10, 2023
Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S, d) 20877007S, e) 20877008S, f)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported May 10, 2023
CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. It creates a tip at cryogenic temperatures…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beaver Visitec International, Inc.
FDA (openFDA device enforcement)
Reported May 10, 2023
DERMLITE DL4W, REF: DL4W, Rx Only MD, CE
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DermLite LLC
FDA (openFDA device enforcement)
Reported May 10, 2023
DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DeVilbiss Healthcare LLC
FDA (openFDA device enforcement)
Reported May 10, 2023
Centricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-061, b) 2066908-077, c) 2066908-086, d)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 10, 2023
Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names of the same product: FlexLab (FLX),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Inpeco S.A.
4 more products in this recall
FDA (openFDA device enforcement)
Reported May 10, 2023
injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length Stainless-stell needle cannula is 25…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Labories Medical Technologies
FDA (openFDA device enforcement)
Reported May 10, 2023
LINK SLED Knee System: ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2020/40
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Linkbio Corp.
47 more products in this recall
FDA (openFDA device enforcement)
Reported May 10, 2023
VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi-quantitative, and qualitative measurement…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
2 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.