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 Oct 22, 2025
DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ConvaTec, Inc.
FDA (openFDA device enforcement)
Reported Oct 22, 2025
Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cook Medical Incorporated
FDA (openFDA device enforcement)
Reported Oct 22, 2025
Product: STA Liatest D-Di; REF: 00515;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Diagnostica Stago, Inc.
FDA (openFDA device enforcement)
Reported Oct 22, 2025
ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon Endo-Surgery Inc.
FDA (openFDA device enforcement)
Reported Oct 22, 2025
FERNO POWER X2 POWERED AMBULANCE COT, Model/Catalog Number: 0015816; FOR USE IN GROUND TRANSPORTATION AMBULANCES.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ferno-Washington Inc.
FDA (openFDA device enforcement)
Reported Oct 22, 2025
Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fisher & Paykel Healthcare, Ltd.
FDA (openFDA device enforcement)
Reported Oct 22, 2025
LOGIQ P10 series with software version R4.5.7 Model Number 5877534
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 22, 2025
Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Iantrek Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 22, 2025
The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Insulet Corporation
FDA (openFDA device enforcement)
Reported Oct 22, 2025
Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Kico Knee Innovation Company
FDA (openFDA device enforcement)
Reported Oct 22, 2025
XERF EFFECTOR 60. Electrosurgical unit.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Lutronic Corporation
FDA (openFDA device enforcement)
Reported Oct 22, 2025
Medline Adult Anesthesia Set, REF DYNJ39985G
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medline Industries, LP
FDA (openFDA device enforcement)
Reported Oct 22, 2025
Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microvention Inc.
FDA (openFDA device enforcement)
Reported Oct 22, 2025
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150
High riskUsing this product could cause serious injury, illness or death — stop using it now.Olympus Corporation of the Americas
22 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 22, 2025
Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Percussionaire Corporation
FDA (openFDA device enforcement)
Reported Oct 22, 2025
Cardiac Workstation 5000; Model Number: 860439;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 22, 2025
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-01…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Spacelabs Healthcare, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 15, 2025
Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abiomed, Inc.
FDA (openFDA device enforcement)
Reported Oct 15, 2025
NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 55, REF E NRT-05055-I The NutraGlide Nasal Feeding…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Applied Medical Technology Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 15, 2025
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (9cm) Tuohy Epidural Needle - Winged and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B Braun Medical Inc.
12 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 15, 2025
SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Inc.
FDA (openFDA device enforcement)
Reported Oct 15, 2025
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Canon Medical System, USA, Inc.
FDA (openFDA device enforcement)
Reported Oct 15, 2025
BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron…
High riskUsing this product could cause serious injury, illness or death — stop using it now.CareFusion 303, Inc.
FDA (openFDA device enforcement)
Reported Oct 15, 2025
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Corneat Vision, Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Free recall alerts
Get alerted about new Medical device recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.
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.