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 Oct 6, 2021
Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Accelerated Care Plus Corporation
FDA (openFDA device enforcement)
Reported Oct 6, 2021
PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Implant Systems LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 6, 2021
Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics Inc. (Navilyst Medical Inc.)
FDA (openFDA device enforcement)
Reported Oct 6, 2021
Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number CX812A3J3AMAD0; and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ARJOHUNTLEIGH POLSKA Sp. z.o.o.
FDA (openFDA device enforcement)
Reported Oct 6, 2021
Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Atrium Medical Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 6, 2021
15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with the Outlook Safety Infusion System and/or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
16 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 6, 2021
DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Inc.
FDA (openFDA device enforcement)
Reported Oct 6, 2021
Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biodex Medical Systems, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 6, 2021
DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ConvaTec, Inc.
FDA (openFDA device enforcement)
Reported Oct 6, 2021
Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Corin Ltd.
9 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 6, 2021
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Datascope Corp.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 6, 2021
Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Deerfield Imaging, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 6, 2021
DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set
High riskUsing this product could cause serious injury, illness or death — stop using it now.Deroyal Industries, Inc. Lafollette
FDA (openFDA device enforcement)
Reported Oct 6, 2021
Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Elekta Inc.
FDA (openFDA device enforcement)
Reported Oct 6, 2021
MOSAIQ Oncology Information System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Elekta, Inc.
FDA (openFDA device enforcement)
Reported Oct 6, 2021
AMX Navigate Mobile X-Ray System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 6, 2021
VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Greiner Bio-One North America, Inc.
FDA (openFDA device enforcement)
Reported Oct 6, 2021
OctoStretch with Stretch Leveller - The combination of this products allows the user to easily adjust/control the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hill-Rom, Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 6, 2021
Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm),…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Imperative Care Inc.
FDA (openFDA device enforcement)
Reported Oct 6, 2021
LYMOL Medical Elite X Class Rigid Bronchoscope System, Part No. BD2410, BB2701, BB2702, BB2401, BB2402, BA2700, BT2000,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Lymol Medical Corporation
FDA (openFDA device enforcement)
Reported Oct 6, 2021
NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038301, UPN H965640383011, 3 Valve Manifold,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medline Industries Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 6, 2021
Norco Ultrasound Gel, Item/Description: NC70479/Norco Ultrasound Gel, 250 mL; NC70479/North Coast Ultrasound Gel, 250…
High riskUsing this product could cause serious injury, illness or death — stop using it now.North Coast Medical Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 6, 2021
BF-N20 OES Bronchofiberscope, Model No. BF-N20
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
9 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 6, 2021
uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Shanghai United Imaging Healthcare Co., Ltd.
1 more product 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.