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 Aug 6, 2025
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Kabi USA, LLC
3 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 6, 2025
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.FUJIFILM Healthcare Americas Corporation
FDA (openFDA device enforcement)
Reported Aug 6, 2025
Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Hamilton Medical AG
FDA (openFDA device enforcement)
Reported Aug 6, 2025
HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.HeartSine Technologies Ltd.
FDA (openFDA device enforcement)
Reported Aug 6, 2025
The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Implant Direct Sybron Manufacturing LLC
FDA (openFDA device enforcement)
Reported Aug 6, 2025
Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Institut Georges Lopez
FDA (openFDA device enforcement)
Reported Aug 6, 2025
IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LTS Therapy Systems, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 6, 2025
Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiopulmonary GmbH
FDA (openFDA device enforcement)
Reported Aug 6, 2025
SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
FDA (openFDA device enforcement)
Reported Aug 6, 2025
LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microbiologics Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 6, 2025
LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microvention Inc.
FDA (openFDA device enforcement)
Reported Aug 6, 2025
Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Osteotec Limited
FDA (openFDA device enforcement)
Reported Aug 6, 2025
Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Phasor Health, LLC
FDA (openFDA device enforcement)
Reported Aug 6, 2025
Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
FDA (openFDA device enforcement)
Reported Aug 6, 2025
Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
18 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 6, 2025
Blood Agar,5% Sheep Blood 100/PK, Product Number R01202
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Remel, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 6, 2025
Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-2011. The kit is an…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Remote Diagnostic Technologies Ltd.
FDA (openFDA device enforcement)
Reported Aug 6, 2025
RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics Inc.
FDA (openFDA device enforcement)
Reported Aug 6, 2025
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 6, 2025
Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Volcano Corp.
FDA (openFDA device enforcement)
Reported Jul 30, 2025
Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Inc.
FDA (openFDA device enforcement)
Reported Jul 30, 2025
BD COR System Software. Model Number: 444829.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
FDA (openFDA device enforcement)
Reported Jul 30, 2025
Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bridge to Life Ltd.
FDA (openFDA device enforcement)
Reported Jul 30, 2025
HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CooperSurgical, 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.