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 20, 2021
United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Uoc USA Inc.
FDA (openFDA device enforcement)
Reported Oct 20, 2021
Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.W L Gore & Associates, Inc.
FDA (openFDA device enforcement)
Reported Oct 13, 2021
Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Aesthetics Systems USA Inc.
FDA (openFDA device enforcement)
Reported Oct 13, 2021
AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics, Inc.
FDA (openFDA device enforcement)
Reported Oct 13, 2021
REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bard Peripheral Vascular Inc.
FDA (openFDA device enforcement)
Reported Oct 13, 2021
Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Inc.
FDA (openFDA device enforcement)
Reported Oct 13, 2021
CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CardioQuip, LLC
4 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 13, 2021
Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Contamac Solutions, Inc.
FDA (openFDA device enforcement)
Reported Oct 13, 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 13, 2021
ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
FDA (openFDA device enforcement)
Reported Oct 13, 2021
GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Djo, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 13, 2021
OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 13, 2021
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Flower Orthopedics Corporation
FDA (openFDA device enforcement)
Reported Oct 13, 2021
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
FDA (openFDA device enforcement)
Reported Oct 13, 2021
ARCH Leg Positioning System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Innovative Orthopedic Technologies, LLC
FDA (openFDA device enforcement)
Reported Oct 13, 2021
TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Johnson & Johnson Surgical Vision Inc.
FDA (openFDA device enforcement)
Reported Oct 13, 2021
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
FDA (openFDA device enforcement)
Reported Oct 13, 2021
Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nox Medical
FDA (openFDA device enforcement)
Reported Oct 13, 2021
Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Paltop Advanced Dental Solutions Ltd.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 13, 2021
Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Ultrasound Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 13, 2021
Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Sentinel CH SpA
FDA (openFDA device enforcement)
Reported Oct 13, 2021
ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Welch Allyn Inc. Mortara
FDA (openFDA device enforcement)
Reported Oct 13, 2021
Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with central venous infusion…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ZOLL Circulation, Inc.
27 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 6, 2021
Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Molecular, Inc.
FDA (openFDA device enforcement)
Free recall alerts
Get alerted about new Medical device recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.
Related categories
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.