All recall categories

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.

13,791 stored notices, reported between Jun 20, 2012 and Oct 28, 2026. Newest first.

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

Reported Jun 10, 2026

Pediatric care bed; Product Designation: KayserBett IDA;

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Kayserbetten GmbH & Co. Kg

FDA (openFDA device enforcement)

Medical devices

Reported Jun 10, 2026

Arvis Hip & Knee 3.0 Instrument Set, REF: IN-28000 containing one of the following components: IN-10500, Impactor…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Kico Knee Innovation Company

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Jun 10, 2026

PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Oculus Technologies

FDA (openFDA device enforcement)

Medical devices

Reported Jun 10, 2026

Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Philips Medical Systems Nederland B.v.

7 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Jun 10, 2026

Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST safire:UD150G-40 /…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Shimadzu Medical Systems

FDA (openFDA device enforcement)

Medical devices

Reported Jun 10, 2026

ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Siemens Medical Solutions USA, Inc.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Jun 10, 2026

Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Microsurgical Knife

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

SSC- Surgical Specialties Corporation

FDA (openFDA device enforcement)

Medical devices

Reported Jun 10, 2026

Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune Waste Management System

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Stryker Corporation

FDA (openFDA device enforcement)

Medical devices

Reported Jun 10, 2026

Aligned Medical AMS16835 Fluids Kit RX

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Windstone Medical Packaging, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Jun 3, 2026

Automated Impella Controller (AIC); Product Code: 0042-0000-US;

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Abiomed, Inc.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Jun 3, 2026

RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U…

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Bolton Medical Inc.

FDA (openFDA device enforcement)

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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.