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 Apr 2, 2025
NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
FDA (openFDA device enforcement)
Reported Mar 26, 2025
LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Contract Systems Inc.
32 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 26, 2025
IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics, Inc.
FDA (openFDA device enforcement)
Reported Mar 26, 2025
Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B Braun Medical Inc.
FDA (openFDA device enforcement)
Reported Mar 26, 2025
Access 2 Immunoassay Analyzer, Catalog Number 81600N
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 26, 2025
Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Brainlab AG
FDA (openFDA device enforcement)
Reported Mar 26, 2025
BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
FDA (openFDA device enforcement)
Reported Mar 26, 2025
Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.FUJIFILM Healthcare Americas Corporation
FDA (openFDA device enforcement)
Reported Mar 26, 2025
Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, &…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Immuno-Mycologics, Inc.
FDA (openFDA device enforcement)
Reported Mar 26, 2025
Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
11 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 26, 2025
VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 26, 2025
Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microbiologics Inc.
FDA (openFDA device enforcement)
Reported Mar 26, 2025
Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine H Set & VitaLine H…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Oridion Medical 1987 Ltd.
9 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 26, 2025
Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Remel, Inc.
FDA (openFDA device enforcement)
Reported Mar 26, 2025
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD, Inc.
13 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 26, 2025
Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Waldemar Link GmbH & Co. KG (Mfg Site)
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 26, 2025
Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Orthopedics Manfacturing Limited-Galway
FDA (openFDA device enforcement)
Reported Mar 19, 2025
Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf Hysterectomy Forceps STR 210MM; (2) REF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 19, 2025
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Mar 19, 2025
CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduced percutaneously in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CardioFocus, Inc.
FDA (openFDA device enforcement)
Reported Mar 19, 2025
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
High riskUsing this product could cause serious injury, illness or death — stop using it now.CareFusion 303, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 19, 2025
Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cordis US Corp.
FDA (openFDA device enforcement)
Reported Mar 19, 2025
COR Disposable Kit, 8 mm. Cartilage Transplant System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Mitek, Inc., a Johnson & Johnson Co.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 19, 2025
GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
6 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.