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 Sep 27, 2023
Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows the user to mix bone cement with a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
6 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 27, 2023
TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to facilitate…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tytek Medical Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 20, 2023
Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abbott Medical
6 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 20, 2023
ASG-001; Ultrasound gel
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Advance Medical Designs, Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 20, 2023
Welch Allyn Connex Spot Monitor
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported Sep 20, 2023
FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BioFire Diagnostics, LLC
FDA (openFDA device enforcement)
Reported Sep 20, 2023
ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory
FDA (openFDA device enforcement)
Reported Sep 20, 2023
Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between the dentin and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Keystone Industries
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 20, 2023
nanoDot D2DNS, for custom calibrate, OTO, Model Number 03033-OTO; radiation monitoring dosimeter used with the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Landauer
37 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 20, 2023
Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Mallinckrodt Manufacturing LLC
FDA (openFDA device enforcement)
Reported Sep 20, 2023
HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
High riskUsing this product could cause serious injury, illness or death — stop using it now.MEDLINE INDUSTRIES, LP - Northfield
FDA (openFDA device enforcement)
Reported Sep 20, 2023
Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
FDA (openFDA device enforcement)
Reported Sep 20, 2023
KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Microbiologics Inc.
FDA (openFDA device enforcement)
Reported Sep 20, 2023
Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
FDA (openFDA device enforcement)
Reported Sep 20, 2023
BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ptw-Freiburg
FDA (openFDA device enforcement)
Reported Sep 20, 2023
remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Remel, Inc.
FDA (openFDA device enforcement)
Reported Sep 20, 2023
ACUSON Redwood 2.0 ultrasound systems, REF: 11503314
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Sep 13, 2023
For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Implant Systems LLC
FDA (openFDA device enforcement)
Reported Sep 13, 2023
Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aomori Olympus Co., Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 13, 2023
Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Vandergrift, Inc.
FDA (openFDA device enforcement)
Reported Sep 13, 2023
ZVU Functional GI Software, REF: ZVU-3
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Diversatek Healthcare
FDA (openFDA device enforcement)
Reported Sep 13, 2023
ISee Ortho-K Lens
Moderate riskThis product could cause temporary or reversible health problems — stop using it.PARAGON VISION SCIENCES, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 13, 2023
Allura Xper series
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.V.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 13, 2023
3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Ultrasound, 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.