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 Sep 2, 2026Updated Sep 7, 2026
Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software Version: Midmark IQecg Plugin versions…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Midmark Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 2, 2026Updated Sep 7, 2026
POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting &…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Sep 2, 2026Updated Sep 7, 2026
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Healthcare (Suzhou) Co., Ltd.
FDA (openFDA device enforcement)
Reported Aug 26, 2026Updated Sep 7, 2026
American Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK - 208400, Model Item Number…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Contract Systems Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 26, 2026Updated Sep 7, 2026
Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-253530, 21-253533, 21-253535, 21-253540,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Arrowhead DE LLC
FDA (openFDA device enforcement)
Reported Aug 26, 2026Updated Sep 7, 2026
Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).
Moderate riskThis product could cause temporary or reversible health problems — stop using it.AVID Medical, Inc.
FDA (openFDA device enforcement)
Reported Aug 26, 2026Updated Sep 7, 2026
BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered Driver 25mm x 15Ga, REF:…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Bard Access Systems, Inc.
FDA (openFDA device enforcement)
Reported Aug 26, 2026Updated Sep 7, 2026
Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Number…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 26, 2026Updated Sep 7, 2026
BMC/REACTHEALTH Luna G3 APAP REF LG 3600
High riskUsing this product could cause serious injury, illness or death — stop using it now.BMC Medical Co., Ltd.
FDA (openFDA device enforcement)
Reported Aug 26, 2026Updated Sep 7, 2026
OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
3 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 26, 2026Updated Sep 7, 2026
Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ConvaTec, Inc.
FDA (openFDA device enforcement)
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)
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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.