Category

Medical Implants Recalls

1,784 medical implants recalls on record from CPSC, FDA, and USDA.

1,784 recalls
High RiskFDA
St. Jude Medical, Cardiac Rhythm Management Division
Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q
Medical Implants·1 affected·Mar 10, 2022
High RiskFDA
St. Jude Medical, Cardiac Rhythm Management Division
Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q
Medical Implants·1 affected·Mar 10, 2022
CriticalFDA
Atrium Medical Corporation
Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85326 85327 85328 8...
Medical Implants·105,968 affected·Mar 3, 2022
CriticalFDA
Atrium Medical Corporation
iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 85403 85404 85405 85406 85407 85408 85409 85410 854...
Medical Implants·68,812 affected·Mar 3, 2022
CriticalFDA
Medtronic Inc
Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
Medical Implants·1,483 affected·Mar 2, 2022
High RiskFDA
Philips Healthcare
Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
Medical Implants·42 affected·Feb 2, 2022
High RiskFDA
Philips North America Llc
Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, ...
Medical Implants·338 affected·Feb 2, 2022
High RiskFDA
Biopro, Inc.
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037
Medical Implants·0 affected·Feb 1, 2022
High RiskFDA
Biopro, Inc.
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814
Medical Implants·0 affected·Feb 1, 2022
High RiskFDA
Biopro, Inc.
Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816
Medical Implants·0 affected·Feb 1, 2022
High RiskFDA
Biopro, Inc.
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197
Medical Implants·0 affected·Feb 1, 2022
High RiskFDA
Biopro, Inc.
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813
Medical Implants·0 affected·Feb 1, 2022
High RiskFDA
Balt Usa, Llc
The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainle...
Medical Implants·51 affected·Jan 4, 2022
High RiskFDA
Medtronic Vascular, Inc.
Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant Stent Graft System Model/REF ENBF2313C120EE; ENBF2313C...
Medical Implants·14,629 affected·Dec 21, 2021
High RiskFDA
Straumann Usa Llc
Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089
Medical Implants·7 affected·Nov 30, 2021
High RiskFDA
Howmedica Osteonics Corp.
Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for sterilization of re-usabl...
Medical Implants·7 affected·Nov 24, 2021
High RiskFDA
Uromedica Inc.
UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
Medical Implants·18 affected·Nov 22, 2021
High RiskFDA
Coloplast Manufacturing Us, Llc
Torosa Saline-Filled Testicular Prosthesis (Size Small)
Medical Implants·19 affected·Nov 9, 2021
High RiskFDA
Medtronic Neuromodulation
Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra (Model 37712), RestoreSensor (Mod...
Medical Implants·10 affected·Nov 4, 2021
High RiskFDA
Medtronic Neuromodulation
Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by the Activa RC (Model 37612) implantable neurostimu...
Medical Implants·6,406 affected·Nov 4, 2021
High RiskFDA
Medtronic Vascular, Inc.
Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF282...
Medical Implants·511 affected·Oct 15, 2021
High RiskFDA
Medtronic Vascular, Inc.
Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
Medical Implants·2 affected·Oct 15, 2021
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and Crome implantable c...
Medical Implants·18,715 affected·Oct 12, 2021
High RiskFDA
Jjgc Industria E Comercio De Materials Dentarios Sa
GM Helix Acqua Implant 3.5x10, Article No. 140.944
Medical Implants·567 affected·Oct 11, 2021
High RiskFDA
Cordis Corporation
SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in ...
Medical Implants·26 affected·Oct 1, 2021
High RiskFDA
Cordis Corporation
SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in ...
Medical Implants·4 affected·Oct 1, 2021
High RiskFDA
Cordis Corporation
SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in...
Medical Implants·4 affected·Oct 1, 2021
High RiskFDA
Omnilife Science
OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary tota...
Medical Implants·7 affected·Oct 1, 2021
High RiskFDA
Cordis Corporation
SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in th...
Medical Implants·4 affected·Oct 1, 2021
High RiskFDA
Cordis Corporation
SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in th...
Medical Implants·9 affected·Oct 1, 2021
High RiskFDA
Mentor Texas, Lp.
MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane. ...
Medical Implants·28,348 affected·Sep 30, 2021
High RiskFDA
Implant Direct Sybron Manufacturing Llc
ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,
Medical Implants·83 affected·Sep 23, 2021
High RiskFDA
Implant Direct Sybron Manufacturing Llc
ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,
Medical Implants·61 affected·Sep 23, 2021
High RiskFDA
W L Gore & Associates, Inc.
Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent ...
Medical Implants·2 affected·Sep 7, 2021
High RiskFDA
Flower Orthopedics Corporation
Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as part of...
Medical Implants·2 affected·Sep 1, 2021
High RiskFDA
Flower Orthopedics Corporation
Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used with any plate that as part of the Flower Small and...
Medical Implants·1 affected·Sep 1, 2021
CriticalFDA
Philips North America Llc
The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications...
Medical Implants·4 affected·Aug 13, 2021
High RiskFDA
Johnson & Johnson Surgical Vision Inc
TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS Simplicity Delivery Sys...
Medical Implants·1 affected·Aug 6, 2021
High RiskFDA
Heartware, Inc.
Medtronic HVAD Pump Implant Kits
Medical Implants·11,851 affected·Aug 6, 2021
High RiskFDA
Versea Diagnostics Llc
Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenzas Type A, and Type B Antige...
Medical Implants·563,290 affected·Jul 27, 2021
High RiskFDA
Paltop Advanced Dental Solutions Ltd
Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide ...
Medical Implants·782 affected·Jul 26, 2021
High RiskFDA
Paltop Advanced Dental Solutions Ltd
Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide ...
Medical Implants·354 affected·Jul 26, 2021
High RiskFDA
Paltop Advanced Dental Solutions Ltd
Scan Abutment WP, Cat. No. 30-70106 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide...
Medical Implants·236 affected·Jul 26, 2021
High RiskFDA
Paltop Advanced Dental Solutions Ltd
Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide...
Medical Implants·337 affected·Jul 26, 2021
High RiskFDA
Paltop Advanced Dental Solutions Ltd
Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide...
Medical Implants·16 affected·Jul 26, 2021
High RiskFDA
Vascutek, Ltd.
The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave Tri...
Medical Implants·159 affected·Jul 8, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-40-XX, Novation GXL Liner, Neutr...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-32-XX, MCS +5GXL Liner 5/15 DEG ...
Medical Implants·89,050 affected·Jun 29, 2021