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 Oct 18, 2023
Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced Surgery Center SAR, Sterile. (2) Presource Block…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
9 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 18, 2023
BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01; CII Safe ES…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
FDA (openFDA device enforcement)
Reported Oct 18, 2023
REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Encore Medical, LP
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 18, 2023
Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Flower Orthopedics Corporation
FDA (openFDA device enforcement)
Reported Oct 18, 2023
10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Medical Care Holdings, Inc.
10 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 18, 2023
3T Heater Cooler System, REF: 16-02-85
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LivaNova Deutschland GmbH
FDA (openFDA device enforcement)
Reported Oct 18, 2023
MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mazor Robotics Ltd.
FDA (openFDA device enforcement)
Reported Oct 18, 2023
THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparoscopic (including…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 18, 2023
CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RoyalVibe Health Ltd.
FDA (openFDA device enforcement)
Reported Oct 18, 2023
Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 18, 2023
Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Techno-Path Manufacturing Ltd.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 11, 2023
API3200MD Mass Spectrometer, Part Number 4466230
Moderate riskThis product could cause temporary or reversible health problems — stop using it.AB Sciex, LLC
3 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 11, 2023
Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids from, parts…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Apellis Pharmaceuticals, Inc.
FDA (openFDA device enforcement)
Reported Oct 11, 2023
Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.ARROW INTERNATIONAL Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 11, 2023
Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bard Peripheral Vascular Inc.
FDA (openFDA device enforcement)
Reported Oct 11, 2023
REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson Infusion Therapy Systems Inc.
FDA (openFDA device enforcement)
Reported Oct 11, 2023
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Blue Belt Technologies, Inc.
FDA (openFDA device enforcement)
Reported Oct 11, 2023
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
15 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 11, 2023
Puritan Bennett Cuff Pressure Manager, REF: 180-03
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien
FDA (openFDA device enforcement)
Reported Oct 11, 2023
LFS Flat screen arm system with surgical lamp for Models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DKK Dai-Ichi Shomei Co., Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 11, 2023
F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems China Co., Ltd.
FDA (openFDA device enforcement)
Reported Oct 11, 2023
Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ge Medical Systems, Israel Ltd.
FDA (openFDA device enforcement)
Reported Oct 11, 2023
Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Getinge USA Sales Inc.
FDA (openFDA device enforcement)
Reported Oct 11, 2023
IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Icecure Medical Ltd.
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.