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 Sep 23, 2026Updated Sep 29, 2026
GM Helix Implant, REF: 109.984;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Straumann USA LLC
FDA (openFDA device enforcement)
Reported Sep 23, 2026Updated Sep 29, 2026
REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 23, 2026Updated Sep 29, 2026
SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Well Lead Medical Co. Ltd.
FDA (openFDA device enforcement)
Reported Sep 23, 2026Updated Sep 29, 2026
Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Model/Catalog Number: HEMO-7,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wilson-Cook Medical Inc.
FDA (openFDA device enforcement)
Reported Sep 16, 2026Updated Sep 22, 2026
Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Atrium Medical Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 16, 2026Updated Sep 22, 2026
Halyard IV Start Kit Non-Sterile REF: KRIV26-02
Moderate riskThis product could cause temporary or reversible health problems — stop using it.AVID Medical, Inc.
FDA (openFDA device enforcement)
Reported Sep 16, 2026Updated Sep 22, 2026
Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF: 899914 899916 899918 UDI codes:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.C.R. Bard Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 16, 2026Updated Sep 22, 2026
Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack, Product…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Given Imaging Ltd.
FDA (openFDA device enforcement)
Reported Sep 16, 2026Updated Sep 22, 2026
HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.HeartSine Technologies Ltd.
FDA (openFDA device enforcement)
Reported Sep 16, 2026Updated Sep 22, 2026
Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed laser energy…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Lutronic Corporation
FDA (openFDA device enforcement)
Reported Sep 16, 2026Updated Sep 29, 2026
Kit: Epidural/Pain TQC 20/Cs, REF: 82465 Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medical Action Industries, Inc. 306
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 16, 2026Updated Sep 22, 2026
MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nipro Renal Soultions USA, Corporation
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 16, 2026Updated Sep 22, 2026
AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Windstone Medical Packaging, Inc.
FDA (openFDA device enforcement)
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
20 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 27, 2026
5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
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)
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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.