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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 Oct 7, 2026Updated Oct 13, 2026

EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number:…

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

Bard Peripheral Vascular Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Oct 7, 2026Updated Oct 13, 2026

Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: B96692 /…

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

Beckman Coulter Mishima K.K.

FDA (openFDA device enforcement)

Medical devices

Reported Oct 7, 2026Updated Oct 13, 2026

Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAP CHOLE , Catalog Number: PGCGLCBAC; 2)…

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

Cardinal Health 200, LLC

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Oct 7, 2026Updated Oct 13, 2026

Brand Name: Ferndale Laboratories; Medline; Custom Interventional Pain Management CIPM Product Name: Mastisol Skin…

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

Custom Interventional Pain Management, LLC

FDA (openFDA device enforcement)

Medical devices

Reported Oct 7, 2026Updated Oct 13, 2026

VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use with a…

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

Draeger, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Oct 7, 2026Updated Oct 13, 2026

HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

HeartSine Technologies Ltd.

FDA (openFDA device enforcement)

Medical devices

Reported Oct 7, 2026Updated Oct 13, 2026

PALACOS MV+G pro 40; PALACOS MV+G pro 80. Model/Catalog Number: 5081290; 5081291. Radiopaque, poly(methyl…

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

Heraeus Medical GmbH (Dental Division)

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Oct 7, 2026Updated Oct 13, 2026

NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232; Illumina DRAGEN Server for NextSeq 550Dx, Catalog…

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

Illumina, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Oct 7, 2026Updated Oct 13, 2026

HOPKINS Telescope 30¿, 4mm REF 10005BA UDI-DI code: 04048551045121 KARL STORZ HOPKINS¿ and HOPKINS¿ II telescopes are…

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

Karl Storz Endoscopy

FDA (openFDA device enforcement)

Medical devices

Reported Oct 7, 2026Updated Oct 13, 2026

Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR107000P BED, MANUAL, MEDLITE

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

Medline Industries, LP

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Oct 7, 2026Updated Oct 13, 2026

Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA; Embosphere 700-900 micrometer 2…

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

Merit Medical Systems, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Oct 7, 2026Updated Oct 13, 2026

Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code: 00763000448806 he Pipeline Flex…

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

Micro Therapeutics, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Oct 7, 2026Updated Oct 13, 2026

NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.

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

Noxbox Ltd.

FDA (openFDA device enforcement)

Medical devices

Reported Oct 7, 2026Updated Oct 13, 2026

Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.

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)

Medical devices

Reported Oct 7, 2026Updated Oct 13, 2026

Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter)…

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

Penumbra Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Oct 7, 2026Updated Oct 13, 2026

In-Line Valve, Product Number: P5-TEE

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

Percussionaire Corporation

3 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Oct 7, 2026Updated Oct 13, 2026

Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333

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

Philips North America LLC

FDA (openFDA device enforcement)

Medical devices

Reported Oct 7, 2026Updated Oct 13, 2026

Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3. 782103 (3.0T), 4. 781271 (3.0T…

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

Philips North America

5 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Oct 7, 2026Updated Oct 13, 2026

Computed Tomography X-ray System, Model: uCT 530 with software

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

Shanghai United Imaging Healthcare Co., Ltd.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Oct 7, 2026Updated Oct 13, 2026

Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223;

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

Siemens Healthcare Diagnostics, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Oct 7, 2026Updated Oct 13, 2026

Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W Model/Catalog…

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

Spectrum Medical Srl

FDA (openFDA device enforcement)

Medical devices

Reported Oct 7, 2026Updated Oct 13, 2026

Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS…

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

Tandem Diabetes Care, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Oct 7, 2026Updated Oct 13, 2026

Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA

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

Volcano Corp.

FDA (openFDA device enforcement)

Medical devices

Reported Oct 7, 2026Updated Oct 13, 2026

CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System

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

Wright Medical Technology, 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.