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 9, 2026Updated Sep 14, 2026
Halyard medical convenience kits labeled as: 1) ENT, Model/Item Number (kit) ACEN89-01; 2) ENT, Model/Item Number (kit)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.AVID Medical, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 9, 2026Updated Sep 14, 2026
Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B Braun Medical Inc.
FDA (openFDA device enforcement)
Reported Sep 9, 2026Updated Sep 14, 2026
Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
19 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 9, 2026Updated Sep 14, 2026
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 9, 2026Updated Sep 14, 2026
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GYN ROBOTIC GSAM ,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
11 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 9, 2026Updated Sep 14, 2026
STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Diagnostica Stago, Inc.
FDA (openFDA device enforcement)
Reported Sep 9, 2026Updated Sep 14, 2026
5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Renal Therapies Group, LLC
6 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 9, 2026Updated Sep 14, 2026
HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN) HEALON EndoCoat PRO, REF:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Johnson & Johnson Surgical Vision, Inc.
FDA (openFDA device enforcement)
Reported Sep 9, 2026Updated Sep 14, 2026
Medline Convenience Kits: 1) CDS840396X, Catalog Number: CDS840396X; 2) CDS840396Y, Catalog Number: CDS840396Y; 3)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medline Industries, LP
28 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 9, 2026Updated Sep 14, 2026
Velys Enabling Tech Robotic-Assist Station REF: 451611001
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medos International Sarl
FDA (openFDA device enforcement)
Reported Sep 9, 2026Updated Sep 14, 2026
Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 2, 2026Updated Sep 7, 2026
American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Contract Systems Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 2, 2026Updated Sep 7, 2026
Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.AVID Medical, Inc.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 2, 2026Updated Sep 7, 2026
Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Canon Medical System, USA, Inc.
FDA (openFDA device enforcement)
Reported Sep 2, 2026Updated Sep 7, 2026
CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5.5mm GENESYs CrossFT Suture…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ConMed Corporation
FDA (openFDA device enforcement)
Reported Sep 2, 2026Updated Sep 7, 2026
Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Renal Therapies Group, LLC
FDA (openFDA device enforcement)
Reported Sep 2, 2026Updated Sep 7, 2026
FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.FUJIFILM Healthcare Americas Corporation
FDA (openFDA device enforcement)
Reported Sep 2, 2026Updated Sep 7, 2026
PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems Information Technologies Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 2, 2026Updated Sep 7, 2026
healthmark ProChek-II, Model Number PT-313, PT-201-12
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Healthmark Industries Co., Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 2, 2026Updated Sep 7, 2026
Structur 2 SC Temporary Resin Cartridge Refill 75Gm, Product Codes: 1) 114-3933, Mfr Product Code 1479; Lots 2536179,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Henry Schein Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 2, 2026Updated Sep 7, 2026
Onli 17cm Hydrophilic Urethral Intermittent Catheter, labeled as: 1) 82081 Ch08-17 Onli Hydrophilic Urethral…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hollister Ulc
FDA (openFDA device enforcement)
Reported Sep 2, 2026Updated Sep 7, 2026
ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.IMRIS Imaging Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 2, 2026Updated Sep 7, 2026
Medline breathing circuits labeled as: 1) MEDLINE HUDSON RCI, CIRCUIT, NEO, SING LIMB, HTD,COLUMN, Medline Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medline Industries, LP
18 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 2, 2026Updated Sep 7, 2026
Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, 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.