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.
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)
Reported Jul 30, 2025
Biofinity XR Toric Contact Lens
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CooperVision, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 30, 2025
Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien
FDA (openFDA device enforcement)
Reported Jul 30, 2025
Portable X-ray system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Digimed Co., Ltd.
FDA (openFDA device enforcement)
Reported Jul 30, 2025
Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Encore Medical, LP
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 30, 2025
SIGNA Architect
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 30, 2025
Bodor's I series laser cutting machine.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Jinan Bodor Cnc Machine Co. Ltd.
FDA (openFDA device enforcement)
Reported Jul 30, 2025
ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Johnson & Johnson Vision Care, Inc.
FDA (openFDA device enforcement)
Reported Jul 30, 2025
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 30, 2025
Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 30, 2025
Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Natus Neurology dba Excel Tech., Ltd. (XLTEK)
FDA (openFDA device enforcement)
Reported Jul 30, 2025
Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone seals fit over the biopsy…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
7 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.