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 25, 2025
SURGIMESH WN, Polymeric Surgical Mesh, Large Flat Sheet, Model/Catalog Number: T3030
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Chamberlain Technologies LLC
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 25, 2025
Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cook Incorporated
FDA (openFDA device enforcement)
Reported Jun 25, 2025
Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1)
High riskUsing this product could cause serious injury, illness or death — stop using it now.Dexcom, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 25, 2025
STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Diagnostica Stago, Inc.
FDA (openFDA device enforcement)
Reported Jun 25, 2025
5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
FDA (openFDA device enforcement)
Reported Jun 25, 2025
Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catalog Number: PM001 Software Version:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Guangzhou Pluslife Biotech Co., Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 25, 2025
AcoSound. Model Number: LW12-BTE-M
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Hangzhou Acosound Technology Co., Ltd.
FDA (openFDA device enforcement)
Reported Jun 25, 2025
ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 25, 2025
GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ohio Medical Corporation
FDA (openFDA device enforcement)
Reported Jun 25, 2025
REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Orthofix Srl
FDA (openFDA device enforcement)
Reported Jun 25, 2025
Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Preat Corp.
FDA (openFDA device enforcement)
Reported Jun 25, 2025
UROSKOP Omnia. Model Number: 10094910
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)
Reported Jun 25, 2025
Lago X
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Spectral Instruments Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 18, 2025
LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K; TOTAL KNEE PACK,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Contract Systems, Inc.
FDA (openFDA device enforcement)
Reported Jun 18, 2025
2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 18, 2025
Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bd Switzerland Sarl
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 18, 2025
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Jun 18, 2025
Allon 2001. Part Number: 200-00263
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Belmont Instrument LLC
FDA (openFDA device enforcement)
Reported Jun 18, 2025
SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow…
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)
Reported Jun 18, 2025
Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Contamac Solutions, Inc.
FDA (openFDA device enforcement)
Reported Jun 18, 2025
BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Copan Italia
FDA (openFDA device enforcement)
Reported Jun 18, 2025
Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Covidien
FDA (openFDA device enforcement)
Reported Jun 18, 2025
IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL.…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
FDA (openFDA device enforcement)
Reported Jun 18, 2025
MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-based computer system…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems Information Technologies Inc.
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.