Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 56 of 548
FDA Devices Moderate Oct 9, 2024
Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyo…
CooperVision, Inc.
FDA Devices Moderate Oct 9, 2024
DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01
FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD
FDA Devices Moderate Oct 9, 2024
DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number ACT01
FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD
FDA Devices Critical Oct 9, 2024
Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
Mercury Enterprises, Inc. dba Mercury Medical
FDA Devices Moderate Oct 9, 2024
BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in a…
CooperVision, Inc.
FDA Devices Moderate Oct 9, 2024
DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD2461AMI Philips Part # 8661…
Philips North America Llc
FDA Devices Moderate Oct 9, 2024
Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
Tornier, Inc
FDA Devices Moderate Oct 9, 2024
Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Oct 9, 2024
BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with …
Becton, Dickinson and Company, BD Bio Sciences
FDA Devices Moderate Oct 2, 2024
Pacemaker, COPM11B; Medical convenience kit
American Contract Systems, Inc.
FDA Devices Critical Oct 2, 2024
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Datascope Corp.
FDA Devices Moderate Oct 2, 2024
WALLFLEX FC ESO STENT RMV LL 18X103- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophage…
Boston Scientific Corporation
FDA Devices Moderate Oct 2, 2024
AGILE ESO OTW PC 23MM X 6.2CM IN 18.5 FR- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaini…
Boston Scientific Corporation
FDA Devices Moderate Oct 2, 2024
Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias. Order Number (GPN): G46603
Cook Biotech, Inc.
FDA Devices Moderate Oct 2, 2024
Hand Pack, AKHD97C; Medical convenience kit
American Contract Systems, Inc.
FDA Devices Critical Oct 2, 2024
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
Fresenius Kabi USA, LLC
FDA Devices Moderate Oct 2, 2024
WALLFLEX PC ESOPH STENT 23/28MM X 105MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal …
Boston Scientific Corporation
FDA Devices Moderate Oct 2, 2024
WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal lumi…
Boston Scientific Corporation
FDA Devices Moderate Oct 2, 2024
Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): …
Cook Biotech, Inc.
FDA Devices Moderate Oct 2, 2024
WALLFLEX ESOPHAGEAL FC 18/23-25MMX15CM- Agile Esophageal Partially Covered and Fully Covered OTW Stent System is intended for maintaining esophageal …
Boston Scientific Corporation
FDA Devices Moderate Oct 2, 2024
BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacter…
Becton Dickinson & Co.
FDA Devices Moderate Oct 2, 2024
(a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888266114, Sterile; (b)…
Cardinal Health 200, LLC
FDA Devices Moderate Oct 2, 2024
Vaginal Delivery, ASDV25B; Medical convenience kit
American Contract Systems, Inc.
FDA Devices Moderate Oct 2, 2024
Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1;…
ARROW INTERNATIONAL Inc.
FDA Devices Moderate Oct 2, 2024
WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal lumin…
Boston Scientific Corporation
FDA Devices Moderate Oct 2, 2024
IR Procedure Pack, CEAT19W; Medical convenience kit
American Contract Systems, Inc.
FDA Devices Moderate Oct 2, 2024
WALLFLEX PC ESOPH STENT 18/23MM X 123MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal …
Boston Scientific Corporation
FDA Devices Moderate Oct 2, 2024
Custom Procedure Kit, REF: K12T-11077
Merit Medical Systems, Inc.
FDA Devices Moderate Oct 2, 2024
WALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophagea…
Boston Scientific Corporation
FDA Devices Moderate Oct 2, 2024
Nasal Sinus Pack, MTSN26B; Medical convenience kit
American Contract Systems, Inc.
FDA Devices Moderate Oct 2, 2024
Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the …
Philips North America Llc
FDA Devices Moderate Oct 2, 2024
Stainless Steel Sims Uterine Sound, Part Number 64-601
CooperSurgical, Inc.
FDA Devices Moderate Oct 2, 2024
Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure o…
Philips North America Llc
FDA Devices Moderate Oct 2, 2024
prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
Centinel Spine, Inc.
FDA Devices Moderate Oct 2, 2024
WALLFLEX FC ESO STENT RMV 23X155MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophagea…
Boston Scientific Corporation
FDA Devices Moderate Oct 2, 2024
AGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining…
Boston Scientific Corporation
FDA Devices Moderate Oct 2, 2024
GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1112198-01045579; 3) M1112198-01047148; 4) M1112198-01047271; 5) M1…
Wipro GE Healthcare Private Ltd.
FDA Devices Moderate Oct 2, 2024
PACEMAKER PACK, SLCV01J; Medical convenience kit
American Contract Systems, Inc.
FDA Devices Moderate Oct 2, 2024
Neuro Vascular, ANKV91A; Medical convenience kit
American Contract Systems, Inc.
FDA Devices Moderate Oct 2, 2024
WALLFLEX FC ESO STENT RMV 23X105MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophagea…
Boston Scientific Corporation
FDA Devices Moderate Oct 2, 2024
WALLFLEX PC ESOPH STENT 18/23MM X 153MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal …
Boston Scientific Corporation
FDA Devices Moderate Oct 2, 2024
Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of t…
Philips North America Llc
FDA Devices Moderate Oct 2, 2024
WALLFLEX FC ESO STENT RMV 18X123MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal…
Boston Scientific Corporation
FDA Devices Moderate Oct 2, 2024
Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structu…
Philips North America Llc
FDA Devices Moderate Oct 2, 2024
WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal …
Boston Scientific Corporation
FDA Devices Moderate Oct 2, 2024
Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit
American Contract Systems, Inc.
FDA Devices Moderate Oct 2, 2024
BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD P…
Becton Dickinson & Co.
FDA Devices Moderate Oct 2, 2024
ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0, 2.5 Diagnostic Ultrasound …
Siemens Medical Solutions USA, Inc.
FDA Devices Moderate Oct 2, 2024
AGILE ESO OTW PC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining…
Boston Scientific Corporation
FDA Devices Moderate Oct 2, 2024
WALLFLEX FC ESO STENT RMV 18X153MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal…
Boston Scientific Corporation