FDA Device · 2016

FDA Device recalls in 2016

RecallRadar indexes 3,246 FDA Device recall notices published in 2016. By classification: 116 Class I, 3,050 Class II, 80 Class III.

• Certain Gingihue Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IAPP454G Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• EP Healing Abutment Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Cover Screw, Headless Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Preformance Post Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• O-Ring Abutment 4.1mm(D) x 2mm(H) Item: OSO20 Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Perioscopy Sheath: Part number: 1008
  FDA Device · Class II · 2016-08-24 · Danville Materials
• Certain Pick-up Coping Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Bellatek Encode Healing Abutment Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Pick-Up Impression Coping Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Certain Gingihue TM 15 degree Angled Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item: IMPAP32G Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Locator Abutment Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Quickbridge TM Cap Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Xpert MRSA Catalog GXMRSA-120, Rev
  FDA Device · Class II · 2016-08-24 · Cepheid
• Certain Gingihue Post Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 2mm(H) Item: IWTH52 Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Prep-tite Cap Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• PEDIATRIC KIDNEY BIOPSY TRAY
  FDA Device · Class II · 2016-08-24 · Avid Medical
• Conical Abutment Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Convenience Kits, MOHS "OPENING" PROCEDURE TRAY
  FDA Device · Class II · 2016-08-24 · Avid Medical
• Locator Replacement Housing Kit Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R36ASP The Valleylab Laparoscopic Handset and Electrodes are indic…
  FDA Device · Class II · 2016-08-24 · Medtronic
• Certain Standard Abutment Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Certain Provide Abutment Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes Item Code: E253028 The Valleylab Laparoscopic Handset and Electrodes are indi…
  FDA Device · Class II · 2016-08-24 · Medtronic
• Certain Conical Abutment Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Conical 17 degree Angled Abutment Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intended for use in total hip arthroplasty for reduction or relief o…
  FDA Device · Class II · 2016-08-24 · Microport Orthopedics
• AB SCIEX QTRAP¿ 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use
  FDA Device · Class II · 2016-08-24 · Ab Sciex
• Valleylab Laparoscopic Argon Sharp Needle Electrode 28CM Item Code: E258228 The Valleylab Laparoscopic Handset and Electrodes are indicated…
  FDA Device · Class II · 2016-08-24 · Medtronic
• Valleylab Laparoscopic Flat L-Hook Electrode 36CM Item Code: E277436 The Valleylab Laparoscopic Handset and Electrodes are indicated for us…
  FDA Device · Class II · 2016-08-24 · Medtronic
• MAMMOGRAPHY
  FDA Device · Class II · 2016-08-24 · Avid Medical
• IOL Pick-Up Impression Coping Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Certain Locator Abutment Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Certain Gingihue Post 5mm(D) x 5mm(P) x 2mm(H) Item: IWPP552G Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• AB SCIEX 3200MD QTRAP¿ LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use
  FDA Device · Class II · 2016-08-24 · Ab Sciex
• Standard Abutment Temporary Screw Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Conical EP Pick-Up Coping (Hexed) Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Certain Preformance 15 degrees Pre-Angled Post Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Merge Unity Z3D software
  FDA Device · Class II · 2016-08-24 · Merge Healthcare
• Temporary Healing Retention Cylinder Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Preformance Temporary Cylinder Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Implant Twist Lock TM Coping Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Temporary Non-Hexed Cylinder Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Certain Non-Hexed Implant Pick-up Coping Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Certain EP Healing Abutment 4.1mm(D) x 5mm(P) x 2mm(H) Item: ITHA52 Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Certain Preformance Temporary Cylinder Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Certain Twist Lock TM Straight Transfer Coping Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Certain Temporary Hexed Cylinder Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Certain Twist Lock TM Coping Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Valleylab Laparoscopic Flexible Laparoscopic Argon Blade Electrodes 28CM Item Code: E258028 The Valleylab Laparoscopic Handset and Electrod…
  FDA Device · Class II · 2016-08-24 · Medtronic
• Implant EP Pick-Up Coping Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Certain Bellatek Encode Healing Abutment Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Drill Stop Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Gold-Tite Square Uniscrew Item: UNISG Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Gingihue Post Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Gold -Tite Hexed Retaining Screw Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Cover Screw Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. Designed to replace the native or surgical b…
  FDA Device · Class II · 2016-08-24 · Medtronic Cardiovascular Surgery The Heart Valve Division
• Provide Protection Cap Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Standard Abutment Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Certain Conical 17 degree Angled Abutment Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Convenience Kits, MOHS "OPENING" PROCEDURE TRAY
  FDA Device · Class II · 2016-08-24 · Avid Medical
• Valleylab Laparoscopic Curved Spatula Electrode 45CM Item Code: E277145 The Valleylab Laparoscopic Handset and Electrodes are indicated for…
  FDA Device · Class II · 2016-08-24 · Medtronic
• Valleylab Laparoscopic Curved Spatula Electrode 36CM Item Code: E277136 The Valleylab Laparoscopic Handset and Electrodes are indicated for…
  FDA Device · Class II · 2016-08-24 · Medtronic
• Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 3" Item Code: E25303 The Valleylab Laparoscopic Handset and Electrodes are in…
  FDA Device · Class II · 2016-08-24 · Medtronic
• Valleylab Laparoscopic Flat L-Hook Electrode 28cm Item Code: E278428 The Valleylab Laparoscopic Handset and Electrodes are indicated for us…
  FDA Device · Class II · 2016-08-24 · Medtronic
• Certain EP Twist Lock TM Coping Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Implant EP Twist Lock TM Coping Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Certain Conical 25 degree Angled Abutment Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Certain Temporary Non-Hexed Cylinder Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Conical EP Healing Cap Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Valleylab Laparoscopic Cylindrical Tip Electrode 28CM Item Code: E278628 The Valleylab Laparoscopic Handset and Electrodes are indicated fo…
  FDA Device · Class II · 2016-08-24 · Medtronic
• Certain Gingihue 15 degree Angled Post Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Prep-Tite Post Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Valleylab Laparoscopic Wire J-Hook Electrode 28CM Item Code: E278228 The Valleylab Laparoscopic Handset and Electrodes are indicated for us…
  FDA Device · Class II · 2016-08-24 · Medtronic
• Valleylab Laparoscopic Argon Modified Flat l Electrode 28CM Item Code: E258128 The Valleylab Laparoscopic Handset and Electrodes are indica…
  FDA Device · Class II · 2016-08-24 · Medtronic
• Valleylab Laparoscopic Straight Spatula Electrode 36C Item Code: E277036 The Valleylab Laparoscopic Handset and Electrodes are indicated fo…
  FDA Device · Class II · 2016-08-24 · Medtronic
• Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 6" Item Code: E25306 The Valleylab Laparoscopic Handset and Electrodes are in…
  FDA Device · Class II · 2016-08-24 · Medtronic
• Index Coping Surgical Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Conical Healing Cap Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• DAL-RO Housing, Female Assembly Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality images, reports, and various t…
  FDA Device · Class II · 2016-08-24 · Merge Healthcare
• Quattro Air FFM MED  AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators
  FDA Device · Class II · 2016-08-24 · Resmed
• Provide Impression Coping Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Valleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277336 The Valleylab Laparoscopic Handset and Electrodes are indicated for us…
  FDA Device · Class II · 2016-08-24 · Medtronic
• O-Ring Abutment 4.1mm(D) x 6mm(H) Item: OSO60 Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Valleylab Laparoscopic Wire J-Hook Electrode Retractable 28CM Item Code: E2782R28ASP The Valleylab Laparoscopic Handset and Electrodes are…
  FDA Device · Class II · 2016-08-24 · Medtronic
• VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device Identifier No. 10758750000227, I…
  FDA Device · Class III · 2016-08-24 · Ortho Clinical Diagnostics
• 1.5 mm HYDRO LeMaitre Valvulotome, 40 cm
  FDA Device · Class II · 2016-08-24 · Lemaitre Vascular
• OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier
  FDA Device · Class II · 2016-08-24 · Nidek
• Certain Implant EP Twist Lock TM Coping Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• LDA Screw SBL 3mm(D) Item: SCRSBL1 Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• Conical EP Twist Lock TM Coping Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• AB SCIEX Triple Quad 4500MD LC/MS/MS System
  FDA Device · Class II · 2016-08-24 · Ab Sciex
• AB Sciex API 3200MD" LC/MS/MS System
  FDA Device · Class II · 2016-08-24 · Ab Sciex
• Titanium Square Uniscrew Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• TI Single Vector Distractor Body with Right Foot/30mm
  FDA Device · Class II · 2016-08-24 · Synthes Usa Products
• Implant Cover Screw Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• O-Ring Abutment 4.1mm(D) x 4mm(H) Item: OSO40 Dental implants
  FDA Device · Class II · 2016-08-24 · Biomet 3i
• TI Single Vector Distractor Proximal Foot/Left
  FDA Device · Class II · 2016-08-24 · Synthes Usa Products

Other years

2026 (2,024) · 2025 (2,908) · 2024 (3,393) · 2023 (2,477) · 2022 (2,191) · 2021 (2,303) · 2020 (3,055) · 2019 (2,801) · 2018 (3,757) · 2017 (2,615) · 2016 (3,246) · 2015 (2,495) · 2014 (3,059) · 2013 (2,249) · 2012 (1,310)