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 30, 2026Updated Oct 24, 2026
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abiomed, Inc.
FDA (openFDA device enforcement)
Reported Sep 30, 2026Updated Oct 24, 2026
Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number:…
High riskUsing this product could cause serious injury, illness or death — stop using it now.AVID Medical, Inc.
FDA (openFDA device enforcement)
Reported Sep 30, 2026Updated Oct 6, 2026
Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 30, 2026Updated Oct 6, 2026
ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 00690103210927 The non-invasive ForeSight oximeter…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton, Dickinson and Company
FDA (openFDA device enforcement)
Reported Sep 30, 2026Updated Oct 6, 2026
VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomerieux Inc.
FDA (openFDA device enforcement)
Reported Sep 30, 2026Updated Oct 6, 2026
Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/038 BX5;…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Boston Scientific Corporation
FDA (openFDA device enforcement)
Reported Sep 30, 2026Updated Oct 6, 2026
Presource Convenience Kits: 1) KIT, PRE OP , Catalog Number: AMN548616A; 2) KIT, NICU ADMIT NEW HAN , Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 30, 2026Updated Oct 15, 2026
INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box. Model…
High riskUsing this product could cause serious injury, illness or death — stop using it now.CooperSurgical, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 30, 2026Updated Oct 6, 2026
Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog Number: Pearle Vision 1 day
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CooperVision, Inc.
FDA (openFDA device enforcement)
Reported Sep 30, 2026Updated Oct 6, 2026
nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, CAT 8100EP1-ST, CAT…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Criticare Technologies, Inc.
FDA (openFDA device enforcement)
Reported Sep 30, 2026Updated Oct 6, 2026
REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DeRoyal Industries Inc.
FDA (openFDA device enforcement)
Reported Sep 30, 2026Updated Oct 6, 2026
CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors; Model Number: 03-2522-1;
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 30, 2026Updated Oct 6, 2026
Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Heidelberg Engineering GmbH
FDA (openFDA device enforcement)
Reported Sep 30, 2026Updated Oct 6, 2026
Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intervascular, Sas
FDA (openFDA device enforcement)
Reported Sep 30, 2026Updated Oct 6, 2026
PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Numbers: 1. ARD568474114A, 2.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet SAS
FDA (openFDA device enforcement)
Reported Sep 30, 2026Updated Oct 8, 2026
Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and Sinus Pack…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medline Industries, LP
5 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 30, 2026Updated Oct 6, 2026
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate,…
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 30, 2026Updated Oct 6, 2026
New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large. Model Number: NYES100-2.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.New York Embroidery Studio, Inc.
FDA (openFDA device enforcement)
Reported Sep 30, 2026Updated Oct 6, 2026
Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 30, 2026Updated Oct 6, 2026
Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers (REF): 1. 781196 (Achieva 1.5T),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
10 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 30, 2026Updated Oct 6, 2026
Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Ultrasound, LLC
FDA (openFDA device enforcement)
Reported Sep 30, 2026Updated Oct 6, 2026
SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Seaspine Orthopedics Corporation
FDA (openFDA device enforcement)
Reported Sep 30, 2026Updated Oct 6, 2026
REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compatible Post Valve
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ventec Life Systems, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 23, 2026Updated Sep 29, 2026
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abiomed, 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.