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 Oct 1, 2025
Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Number ACC010369B; 2. ADULT ICU INTUBATION…
High riskUsing this product could cause serious injury, illness or death — stop using it now.MEDLINE INDUSTRIES, LP - Northfield
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 1, 2025
BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mindray DS USA, Inc. dba Mindray North America
FDA (openFDA device enforcement)
Reported Oct 1, 2025
Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortoma Ab
FDA (openFDA device enforcement)
Reported Oct 1, 2025
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
12 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 1, 2025
Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
9 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 1, 2025
Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Communications
FDA (openFDA device enforcement)
Reported Oct 1, 2025
t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tandem Diabetes Care, Inc.
FDA (openFDA device enforcement)
Reported Sep 24, 2025
3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370
High riskUsing this product could cause serious injury, illness or death — stop using it now.3M Company
FDA (openFDA device enforcement)
Reported Sep 24, 2025
i-STAT CG4+ cartridge (white). List Number: 03P85-25.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Point Of Care Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 24, 2025
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Agilent Technologies Denmark ApS
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 24, 2025
UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 24, 2025
The product is a handheld ultraviolet-C germicidal wand and contains a narrow-diameter, tubular lamps with a peak…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BigTree Sales Inc.
FDA (openFDA device enforcement)
Reported Sep 24, 2025
Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Neuromodulation Corporation
FDA (openFDA device enforcement)
Reported Sep 24, 2025
SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.C.R. Bard Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 24, 2025
Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 24, 2025
Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Folsom Metal Products, Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 24, 2025
Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 24, 2025
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Max Mobility LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 24, 2025
MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medical Information Technology, Inc.
FDA (openFDA device enforcement)
Reported Sep 24, 2025
Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 24, 2025
Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems (Cleveland) Inc.
FDA (openFDA device enforcement)
Reported Sep 17, 2025
Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.AVID Medical, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 17, 2025
Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 5433742 Software Version:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B.Braun Medical S.A.S.
FDA (openFDA device enforcement)
Reported Sep 17, 2025
Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011; 2. H74904526052; 3. M0067101140;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
5 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.