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 Apr 2, 2025
Baxter Operating table column TS7500 MOBIUS, Product Code 1704695
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
15 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 2, 2025
CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Calyxo, Inc.
FDA (openFDA device enforcement)
Reported Apr 2, 2025
Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Small…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Checkpoint Surgical Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 2, 2025
Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigmatism, Pearle Vision 1…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CooperVision, Inc.
FDA (openFDA device enforcement)
Reported Apr 2, 2025
Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
High riskUsing this product could cause serious injury, illness or death — stop using it now.Covidien
FDA (openFDA device enforcement)
Reported Apr 2, 2025
namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
28 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 2, 2025
Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
FDA (openFDA device enforcement)
Reported Apr 2, 2025
Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microbiologics Inc.
FDA (openFDA device enforcement)
Reported Apr 2, 2025
Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Orthofix U.S. LLC
FDA (openFDA device enforcement)
Reported Apr 2, 2025
Premier Solo Diamond - Large Invented Cone; SKU: 807016C.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Premier Dental Products Co.
FDA (openFDA device enforcement)
Reported Apr 2, 2025
CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.St. Jude Medical
FDA (openFDA device enforcement)
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)
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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.