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 26, 2026Updated Sep 7, 2026
EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien, LLC
FDA (openFDA device enforcement)
Reported Aug 26, 2026Updated Sep 7, 2026
Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fort Defiance Industries, LLC
FDA (openFDA device enforcement)
Reported Aug 26, 2026Updated Sep 7, 2026
Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Foundation Medicine, Inc.
FDA (openFDA device enforcement)
Reported Aug 26, 2026Updated Sep 7, 2026
Blanketrol II Model 222S; Thermal regulating system.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Gentherm Medical, LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 26, 2026Updated Sep 7, 2026
One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intersurgical Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 26, 2026Updated Sep 7, 2026
Brand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2 Model/Catalog Number: IN-29200…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Kico Knee Innovation Company
FDA (openFDA device enforcement)
Reported Aug 26, 2026Updated Sep 7, 2026
GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; part of the SERVO-U/-N continuous ventilator system,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Critical Care AB
FDA (openFDA device enforcement)
Reported Aug 26, 2026Updated Sep 7, 2026
MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 26, 2026Updated Sep 7, 2026
Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Paragon 28, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 26, 2026Updated Sep 7, 2026
Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Paragonix Technologies Inc.
FDA (openFDA device enforcement)
Reported Aug 26, 2026Updated Sep 7, 2026
Cardiac Workstation 5000. Product Number: 860439.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 26, 2026Updated Sep 7, 2026
Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.restor3d Inc.
FDA (openFDA device enforcement)
Reported Aug 26, 2026Updated Sep 7, 2026
Dentsply Sirona Capsule Mixer Model No. 5546068
Moderate riskThis product could cause temporary or reversible health problems — stop using it.SDI Limited
FDA (openFDA device enforcement)
Reported Aug 26, 2026Updated Sep 7, 2026
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics Products Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 26, 2026Updated Sep 7, 2026
Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 26, 2026Updated Sep 7, 2026
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 Aug 26, 2026Updated Sep 7, 2026
TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tobii Dynavox LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 19, 2026Updated Aug 25, 2026
Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 19, 2026Updated Aug 25, 2026
60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext Set w/Needleless and Y-Site…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bd Switzerland Sarl
FDA (openFDA device enforcement)
Reported Aug 19, 2026Updated Aug 25, 2026
BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BioFire Diagnostics, LLC
FDA (openFDA device enforcement)
Reported Aug 19, 2026Updated Aug 25, 2026
ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bioporto Diagnostics A/S
FDA (openFDA device enforcement)
Reported Aug 19, 2026Updated Aug 25, 2026
Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
7 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 19, 2026Updated Aug 25, 2026
V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOCM0436…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien, LP
4 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 19, 2026Updated Sep 7, 2026
ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Erbe USA 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.