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 Dec 1, 2021
Cardioblate CryoFlex Surgical Ablation Console
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
FDA (openFDA device enforcement)
Reported Dec 1, 2021
Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 1, 2021
Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Healthcare
3 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 1, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - CT Vision ACQSIM CT System Number: 728209 Continuous…
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 Dec 1, 2021
SOMATOM Force with software syngo.CT VB20 Model #10742326
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
16 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 1, 2021
Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Binding Site Group, Ltd.
FDA (openFDA device enforcement)
Reported Dec 1, 2021
Roberts Digital VIPR System (with E-size cylinder) Model: ROC-9840
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Western/Scott Fetzer Company
3 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 24, 2021
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-12709-WC The…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Arrow International Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 24, 2021
Beaver Xstar Crescent Knife, 2.5mm, 55 degrees, bevel down. Intended for or cataract surgery. REF#: 373809
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beaver Visitec International, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 24, 2021
BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total & RPR kit is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bio-Rad Laboratories, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 24, 2021
API 50 CH, Model 50300
Moderate riskThis product could cause temporary or reversible health problems — stop using it.bioMerieux, Inc.
FDA (openFDA device enforcement)
Reported Nov 24, 2021
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 24, 2021
LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CooperSurgical, Inc.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 24, 2021
SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cordis Corporation
5 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 24, 2021
Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fujifilm Irvine Scientific, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 24, 2021
Torque Limiting Adaptor, AO Connect, 4 N-m, part #027-203, reusable, a component of the Bodycad Fine Osteotomy Implant…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Laboratoires Bodycad, Inc.
FDA (openFDA device enforcement)
Reported Nov 24, 2021
Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medicalplastic S.R.L.
FDA (openFDA device enforcement)
Reported Nov 24, 2021
OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.OmniLife Science
FDA (openFDA device enforcement)
Reported Nov 24, 2021
VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Ortho-Clinical Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Nov 24, 2021
Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601 urinalysis test system is comprised of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
FDA (openFDA device enforcement)
Reported Nov 24, 2021
REGARD Basic Cataract tray
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
6 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 24, 2021
Scrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultrasound transducer to tissue
High riskUsing this product could cause serious injury, illness or death — stop using it now.Scrip Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 24, 2021
Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Nov 24, 2021
Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, 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.