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 Jun 17, 2026
Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Inter-Med LLC
FDA (openFDA device enforcement)
Reported Jun 17, 2026
Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medartis AG
FDA (openFDA device enforcement)
Reported Jun 17, 2026
SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Micromed S.p.A.
FDA (openFDA device enforcement)
Reported Jun 17, 2026
Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Catheter with Straight…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mozarc Medical US LLC
FDA (openFDA device enforcement)
Reported Jun 17, 2026
DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
FDA (openFDA device enforcement)
Reported Jun 17, 2026
NexxZr T Multi A3.5 W98-16mm, REF: 745451
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sagemax Bioceramics, Inc.
FDA (openFDA device enforcement)
Reported Jun 17, 2026
Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Jun 17, 2026
Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Binding Site Group, Ltd.
FDA (openFDA device enforcement)
Reported Jun 10, 2026
Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Advanced Bionics, LLC
FDA (openFDA device enforcement)
Reported Jun 10, 2026
Brand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE ANESTHESIA TRAY Model/Catalog Number: 555076 Software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B Braun Medical Inc.
10 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 10, 2026
Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product Description:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported Jun 10, 2026
Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad¿ Avanta Injection…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bayer Medical Care, Inc.
FDA (openFDA device enforcement)
Reported Jun 10, 2026
BD¿Spinal Tray with BD¿Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Becton Dickinson & Company
9 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 10, 2026
BD Pyxis MedStation 4000 REF: 303 Medication cabinet
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 10, 2026
COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 10, 2026
Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien, LP
FDA (openFDA device enforcement)
Reported Jun 10, 2026
Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Daavlin Distributing Company
FDA (openFDA device enforcement)
Reported Jun 10, 2026
DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DeRoyal Industries Inc.
FDA (openFDA device enforcement)
Reported Jun 10, 2026
Atlan A350. Model Number: 8211500. anesthesia workstation
High riskUsing this product could cause serious injury, illness or death — stop using it now.Draeger, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 10, 2026
LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 10, 2026
MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems China Co., Ltd.
FDA (openFDA device enforcement)
Reported Jun 10, 2026
CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems Information Technologies Inc.
FDA (openFDA device enforcement)
Reported Jun 10, 2026
TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Grace Medical, Inc.
FDA (openFDA device enforcement)
Reported Jun 10, 2026
Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
FDA (openFDA device enforcement)
Free recall alerts
Get alerted about new Medical device recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.
Related categories
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.