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 Aug 25, 2021
ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon Endo-Surgery Inc.
FDA (openFDA device enforcement)
Reported Aug 25, 2021
Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hitachi Healthcare Americas Corporation
FDA (openFDA device enforcement)
Reported Aug 25, 2021
Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
FDA (openFDA device enforcement)
Reported Aug 25, 2021
Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Aug 25, 2021
OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
Moderate riskThis product could cause temporary or reversible health problems — stop using it.OPTI Medical Systems, Inc.
FDA (openFDA device enforcement)
Reported Aug 25, 2021
CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho8, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 25, 2021
FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ostial Corporation
FDA (openFDA device enforcement)
Reported Aug 25, 2021
728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
4 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 25, 2021
Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Respironics, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 25, 2021
EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxi
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Ultrasound Inc.
FDA (openFDA device enforcement)
Reported Aug 25, 2021
RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical Europe Ltd.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 25, 2021
The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS only: a) Catalog # DWH039 - Diameter 39 mm…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tornier S.A.S.
FDA (openFDA device enforcement)
Reported Aug 25, 2021
Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.W L Gore & Associates, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 18, 2021
Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories, Inc.
FDA (openFDA device enforcement)
Reported Aug 18, 2021
Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100 Blood Collection Card and Foil Bags Quantity…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Advance Dx, Inc.
FDA (openFDA device enforcement)
Reported Aug 18, 2021
TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 15 cm; TJC3513…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bard Peripheral Vascular Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 18, 2021
Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 18, 2021
ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 18, 2021
Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 - Kaluza C Single Perpetual License…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Aug 18, 2021
FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BioFire Diagnostics, LLC
FDA (openFDA device enforcement)
Reported Aug 18, 2021
Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted…
High riskUsing this product could cause serious injury, illness or death — stop using it now.BioMedical Equipment Service Co. (BMES)
FDA (openFDA device enforcement)
Reported Aug 18, 2021
ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomerieux Inc.
FDA (openFDA device enforcement)
Reported Aug 18, 2021
MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BioMerieux SA
FDA (openFDA device enforcement)
Reported Aug 18, 2021
Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number: 11-301300
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
16 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.