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 19, 2022
Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Oct 19, 2022
Positron Emission Tomography and Computed Tomography System, Model: uMI 550
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Shanghai United Imaging Healthcare Co., Ltd.
FDA (openFDA device enforcement)
Reported Oct 19, 2022
Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
FDA (openFDA device enforcement)
Reported Oct 12, 2022
Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B Braun Medical Inc.
FDA (openFDA device enforcement)
Reported Oct 12, 2022
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
FDA (openFDA device enforcement)
Reported Oct 12, 2022
The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hologic, Inc.
FDA (openFDA device enforcement)
Reported Oct 12, 2022
The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.In My Bathroom LLC
FDA (openFDA device enforcement)
Reported Oct 12, 2022
MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
FDA (openFDA device enforcement)
Reported Oct 12, 2022
Philips Respironics Amara View Minimal Contact Full-Face Mask
High riskUsing this product could cause serious injury, illness or death — stop using it now.Philips Respironics, Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 12, 2022
Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
FDA (openFDA device enforcement)
Reported Oct 12, 2022
stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wright Medical Technology, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 12, 2022
G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
FDA (openFDA device enforcement)
Reported Oct 5, 2022
VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box contains 5 Procedure Kits). For…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics, Inc.
FDA (openFDA device enforcement)
Reported Oct 5, 2022
Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbers: a) K9303078A, b) K9303097A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Barco Nv
FDA (openFDA device enforcement)
Reported Oct 5, 2022
Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported Oct 5, 2022
VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.bioMerieux, Inc.
FDA (openFDA device enforcement)
Reported Oct 5, 2022
TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001.…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cardiac Assist, Inc.
FDA (openFDA device enforcement)
Reported Oct 5, 2022
BD Pyxis MedBank Cabinet Software v2.1.2.9 Legacy MedBank Cabinets with Matrix Drawers include: . CUBEX MedFlex…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
FDA (openFDA device enforcement)
Reported Oct 5, 2022
Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the following brand…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Collagen Matrix Inc.
FDA (openFDA device enforcement)
Reported Oct 5, 2022
Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number: THSF-35-145-AES-SGH (GPN G06801)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Incorporated
23 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 5, 2022
Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (AY102295). The Mark…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CooperSurgical, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 5, 2022
Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DICOM Grid, Inc. d/b/a Ambra Health
FDA (openFDA device enforcement)
Reported Oct 5, 2022
Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
FDA (openFDA device enforcement)
Reported Oct 5, 2022
Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Leica Microsystems, Inc.
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.