Skip to main content
1,784 recalls
CriticalFDA
Thoratec Llc
Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N/A Product Descr...
Medical Implants·53 affected·Jun 23, 2025
High RiskFDA
Osteotec Limited
Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4), OSTF-5 (Sz. 5...
Medical Implants·15,573 affected·Jun 18, 2025
High RiskFDA
Boston Scientific Neuromodulation Corporation
Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect Decompression Sys...
Medical Implants·70,516 affected·Jun 6, 2025
High RiskFDA
Canary Medical, Inc.
Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem ...
Medical Implants·106 affected·May 2, 2025
High RiskFDA
Abbott Molecular, Inc.
Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) te...
Medical Implants·656 affected·Apr 28, 2025
High RiskFDA
Prismatik Dentalcraft, Inc.
Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V The Glidewel...
Medical Implants·15 affected·Apr 14, 2025
High RiskFDA
Zimmer, Inc.
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 802802202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/P...
Medical Implants·158 affected·Mar 24, 2025
High RiskFDA
Zimmer, Inc.
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Number 802602203; Prosthesis, Hip, Semi-Constrained, Metal/Cera...
Medical Implants·215 affected·Mar 24, 2025
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILE...
Medical Implants·7,453 affected·Mar 14, 2025
High RiskFDA
Cordis Us Corp
Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
Medical Implants·20 affected·Mar 4, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) NEURO PACK WRO-LF, Model Number: DYNJ41856C; 2) STIM IMPLANT PACK, Model Numb...
Medical Implants·354 affected·Mar 3, 2025
High RiskFDA
Zimmer Orthopedics Manfacturing Limited-galway
Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606...
Medical Implants·90 affected·Mar 3, 2025
High RiskFDA
Stryker Spine
Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.
Medical Implants·56 affected·Feb 28, 2025
High RiskFDA
Stryker Spine
Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.
Medical Implants·64 affected·Feb 28, 2025
High RiskFDA
Orthofix U.s. Llc
Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: (1) REF 82-3300SP...
Medical Implants·20 affected·Feb 20, 2025
CriticalFDA
Smiths Medical Asd, Inc.
smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24
Medical Implants·0 affected·Feb 13, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088; 2) AV FISTULA PACK-LF, Pack Number DYNJ0131782J; 3) ...
Medical Implants·3,860 affected·Feb 11, 2025
High RiskFDA
Hiossen Inc.
ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a dental implant to provide support for prosthetic restorations s...
Medical Implants·16 affected·Jan 27, 2025
High RiskFDA
Hiossen Inc.
Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended for use with a dental implant to provide supo...
Medical Implants·19 affected·Jan 27, 2025
High RiskFDA
Hiossen Inc.
ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended for use with a dental implant to provide support for prosthetic restorations s...
Medical Implants·48 affected·Jan 27, 2025
High RiskFDA
Hiossen Inc.
ET Rigid Abutment (Mini) SIze: 4.5D 3.0G/H 7.0H - Intended for use with a dental implant to provide support for prosthetic restorations s...
Medical Implants·19 affected·Jan 27, 2025
High RiskFDA
Hiossen Inc.
ET Rigid Abutment (Mini) Size: 4.5D 2.0G/H 4.0H- Intended for use with a dental implant to provide support for prosthetic restorations su...
Medical Implants·19 affected·Jan 27, 2025
CriticalFDA
Spectranetics Corporation
Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm...
Medical Implants·2,939 affected·Jan 10, 2025
High RiskFDA
Exactech, Inc.
AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-32-27 AM EHXL 0¿ LNR G 32MM 140-32-28 AM EHXL 0¿ ...
Medical Implants·42 affected·Dec 31, 2024
High RiskFDA
Boston Scientific Corporation
AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740
Medical Implants·12 affected·Dec 20, 2024
High RiskFDA
Boston Scientific Corporation
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540
Medical Implants·519 affected·Dec 20, 2024
High RiskFDA
Boston Scientific Corporation
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560
Medical Implants·1,102 affected·Dec 20, 2024
High RiskFDA
Boston Scientific Corporation
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550
Medical Implants·1,530 affected·Dec 20, 2024
High RiskFDA
Boston Scientific Corporation
AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650
Medical Implants·1,144 affected·Dec 20, 2024
High RiskFDA
Boston Scientific Corporation
AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670
Medical Implants·309 affected·Dec 20, 2024
High RiskFDA
Boston Scientific Corporation
AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680
Medical Implants·31 affected·Dec 20, 2024
High RiskFDA
Boston Scientific Corporation
AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640
Medical Implants·495 affected·Dec 20, 2024
High RiskFDA
Integra Lifesciences Corp.
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides constant intraven...
Medical Implants·132 affected·Dec 16, 2024
High RiskFDA
Microvention Inc.
MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297. The intended p...
Medical Implants·11 affected·Dec 11, 2024
High RiskFDA
Moximed, Inc.
MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
Medical Implants·115 affected·Dec 2, 2024
High RiskFDA
Medtronic Neuromodulation
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL with the A810 CP a...
Medical Implants·566 affected·Nov 21, 2024
High RiskFDA
Medtronic Neuromodulation
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with the A810 CP app v...
Medical Implants·59 affected·Nov 21, 2024
High RiskFDA
Abbott Medical
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which oper...
Medical Implants·7,295 affected·Nov 21, 2024
High RiskFDA
Abbott Vascular Inc
20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or d...
Medical Implants·3,673 affected·Nov 6, 2024
High RiskFDA
Cartiva, Inc
Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mm), CAR-12-US (12mm)
Medical Implants·0 affected·Oct 31, 2024
High RiskFDA
Microport Orthopedics Inc.
EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR NON-POROUS SIZE ...
Medical Implants·32 affected·Oct 29, 2024
High RiskFDA
Medline Industries, Lp - Northfield
(1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ904220F, 1 kit/cas...
Medical Implants·360 affected·Oct 15, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I; 2) ENT MINOR, REF CDS983466L; 3) EAR, REF CDS983486K; ...
Medical Implants·24,754 affected·Oct 9, 2024
High RiskFDA
Limacorporate S.p.a
TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total elbow prosthe...
Medical Implants·87 affected·Oct 2, 2024
High RiskFDA
Smith & Nephew Inc
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SE...
Medical Implants·2 affected·Oct 2, 2024
High RiskFDA
Smith & Nephew Inc
smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275; Uncoated knee femur p...
Medical Implants·8 affected·Oct 2, 2024
High RiskFDA
Smith & Nephew Inc
smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, meta...
Medical Implants·5 affected·Oct 2, 2024
RecallFDA
Abbott Medical
Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implante...
Medical Implants·130 affected·Oct 1, 2024