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.
- Covidien Dover KIT/STERILE PRESERVE CULT Item Code: 8000SA Castile soap towelettes are used to clean the genital area for male and female p…
FDA Device · Class II · 2016-03-30 · Covidien - Covidien Dover P400 UM 16FR SIL COUDE SECURE Item Code: P4P16CSDK Castile soap towelettes are used to clean the genital area for male and f…
FDA Device · Class II · 2016-03-30 · Covidien - Covidien Dover 7 OZ MIDSTREAM W/CAST SOAP Item Code: 24035 Castile soap towelettes are used to clean the genital area for male and female p…
FDA Device · Class II · 2016-03-30 · Covidien - cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis
FDA Device · Class II · 2016-03-30 · Roche Diagnostics Operations - Covidien Dover ¿18 FR/CH SILVER-HYDROGEL COATED SILICONE FOLEY CATHETER WITH COUD¿ TIP PRE-CONNECTED TO 400 ML URINE METER WITH 2000 ML DRA…
FDA Device · Class II · 2016-03-30 · Covidien - Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092
FDA Device · Class II · 2016-03-30 · Carefusion 303 - Covidien Dover P400 PREM U/M 18FR SIL COUDE CATH SECURE Item Code: P4P18CSD Castile soap towelettes are used to clean the genital area for…
FDA Device · Class II · 2016-03-30 · Covidien - Covidien Dover MIDSTREAM KIT CASTILE SOAP Item Code: 2090SA Castile soap towelettes are used to clean the genital area for male and female…
FDA Device · Class II · 2016-03-30 · Covidien - Covidien Dover MIDSTREAM KIT CASTILE SOAP Item Code: 2040SA Castile soap towelettes are used to clean the genital area for male and female…
FDA Device · Class II · 2016-03-30 · Covidien - Covidien Dover PREC PRM 18FR SILVER FLY TY Item Code: PP18XSD Castile soap towelettes are used to clean the genital area for male and femal…
FDA Device · Class II · 2016-03-30 · Covidien - Covidien Dover CATCH KIT SOAP Item Code: 5205 Castile soap towelettes are used to clean the genital area for male and female patients
FDA Device · Class II · 2016-03-30 · Covidien - Universal Clamp¿ System (IFU reference: SNA027-N-90001)
FDA Device · Class II · 2016-03-30 · Zimmer Spine - Covidien Dover P400 PREM U/M 16FR SIL FLY Item Code: P4P16SD Castile soap towelettes are used to clean the genital area for male and female…
FDA Device · Class II · 2016-03-30 · Covidien - IMMULITE 2000 EstradiolTest Code E2 Catalog Number: L2KE22, L2KE22 (D), L2KE26, L2KE26 (D) SMN: 10381178, 10702833, 10381177, 10702834 Prod…
FDA Device · Class II · 2016-03-30 · Siemens Healthcare Diagnostics - QFT TB Antigen Tube
FDA Device · Class II · 2016-03-30 · Qiagen Sciences - Product 48 consists of all product under product code: JWH and same usage: Item no: 597206526 NEXGEN ALL-POLY PATELLA, for use in total kne…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 59 consists of all product under product code: JWH and same usage: Item no: 42540000026 PSN ALL POLY PAT PLY 26MM 42540000029 PSN A…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver)
FDA Device · Class II · 2016-03-23 · Pro Dex - Product 40 consists of all product under product code: HSB and same usage: Item no: 225706565 ITST ANTI-ROTATION SCREW 225707065 ITST ANTI-…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Prime Series Stretchers (Fifth Wheel, Big Wheel and Zoom) Powered stretcher
FDA Device · Class II · 2016-03-23 · Stryker Medical Division - ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in dental surgery such as: -Augmentation or reconstructive treatmen…
FDA Device · Class III · 2016-03-23 · Collagen Matrix - Product 34 consists of all product under product code: JWH and same usage: Item no: 522001700 I/B II KNEE DOMED PATELLA 522001800 I/B II KN…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 4 consists of all products under product code HWC, and same usage: Item no: 47482002603 2.0 X 26 CORT SCREW CRUCI 47482002803 2.0 X…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 28 consists of all product under product code: JDI and same usage: Item no: 32902605000 FEMORAL HD 28MM MEDIUM 32902604000 FEMORAL…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 23 consists of all product code: JDI and same usage: Item no: 801100220 CPT 2 HIP STEM, X-OFFSET 801100320 CPT 3 HIP STEM, X-OFFSET…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Glucose Monitoring System Accu-Chek inform II Blood Glucose Monito…
FDA Device · Class II · 2016-03-23 · Roche Diagnostics Operations - Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007
FDA Device · Class II · 2016-03-23 · Carefusion 303 - Product 58 consists of all product under product code: HRS and same usage: Item no: 234800904 PROXIMAL DORSAL ULNA PLT 234800906 PROXIMAL D…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - NuOss XC Sinus Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height) Reference No 509-3002 (BMCU22, size 22 mm diameter x 12 m…
FDA Device · Class II · 2016-03-23 · Collagen Matrix - Product 5 consists of all products under product code HWC, and same usage: Item no: 47482701001 2.7MM CORT. SCREW 10MM, S 47482701201 2.7MM…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 46 consists of all product under product code: HWC and same usage: Item no: 114204012 MINI MAGNA-FX CANN SCREW 114204016 MINI MAGNA…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 65 consists of all product under product code: KTT and same usage: Item no: 119413594 VERSA-FX II KEYLESS SHORT 119413595 VERSA-FX…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 12 consists of all product under product code JDI , and same usage: Item no: 902602935 6 DEGREE COCR FEM HEAD 28 902602835 6 DEGREE…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 68 consists of all product under product code: JDI and same usage: Item no: 787101360 VERSYS CEM/REV/CALCAR 13X 787101361 VERSYS CE…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 19 consists of all product code: JDI and same usage: Item no: 765301101 CEM FEM ST 11X120 NOCOAT 765301201 CEM FEM ST 12X125 NOCOAT…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalo…
FDA Device · Class II · 2016-03-23 · Sekisui Diagnostics P E I - Product 14 consists of all product under product code HSB , and same usage: Item no: 225600230 ASIA ONE-PIECE LAG SCREW 225600232 ASIA ONE-…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 54 consists of all product under product code: JWH and same usage: Item no: 596009900 NEXGEN TAPER PLUG for use in total knee arthr…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 63 consists of all product under product code: LPH and same usage: Item no: 620004020 TRILOGY ACET SHELL 40MM O 620004220 TRILOGY A…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 15 consists of all product code JDI , and same usage: Item no: 805002802 ASTEL FEM HEAD +0X28MM DI 805002805 ASTEL FEM HEAD +10.5X2…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 13 consists of all product under product code HWC , and same usage: Item no: 47486510002 6.5 X 100 CANC SCREW, 32M Product Usage: A…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 10consists of all product under product code HWC, and same usage: Item no: 47484502601 4.5 X 26 CORT SCREW SELF Product Usage: A sm…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 50 consists of all product under product code: JWH and same usage: Item no: 595002701 NEXGEN MIS TIBIA PLATE PR 595002702 NEXGEN MI…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - The Vesa 75/100 adaptation with rotation is an accessory to a surgical camera intended to be used to record operative procedures
FDA Device · Class II · 2016-03-23 · Richard Wolf Medical Instruments - Product 60 consists of all product under product code: HSB and same usage: Item no: 225207055 RECON SCREW LG 5.5MM DIA 225207555 RECON SCRE…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical…
FDA Device · Class II · 2016-03-23 · Chg Hospital Beds - Product 62 consists of all product under product code: LPH and same usage: Item no: 620003620 TRILOGY ACET SHELL 36MM OD MULTI For use in t…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 42 consists of all product under product code: HSB and same usage: Item no: 225224010 M/DN FEM IM NAIL 10MM DIA 225228010 M/DN FEM…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 47 consists of all product under product code: LPH and same usage: Item no: 611004022 MODULAR CUP 10 DEGREE LIN 611004428 MODULAR C…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 20 consists of all prod oct under poduct code: KTT and same usage: Item no: 47116201900 COMPRESSION SCREW 1/2IN 47116202300 COMPRES…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 53 consists of all product under: product code: JWH and same usage: Item no: 597002501 NEXGEN PRECOAT PEG TIB PL 597002502 NEXGEN P…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 26 consists of all product under product code: JWH and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL ME…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 43 consists of all product under product code: HSB and same usage: Item no: 224001016 M/DN R-F IM NAIL 10MM DIA 224001018 M/DN R-F…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx)
FDA Device · Class II · 2016-03-23 · Covidien Formerly Nellcor Puritan Bennett - Product 45 consists of all product under product code: JWH and same usage: Item no: 511007020 MGII KNEE SLF-TAP BONE ST 511007025 MGII KNEE…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 64 consists of all product under product code: JDI and same usage: Item no: 902605101 UNIPOLAR ENDO FEM HEAD 51MM For use in hemi h…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 3 consists of all products under product code JDI, and same usage: Item no:781803800 12/14 UNIPOLAR FEMORAL HE 781804000 12/14 UNIP…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 17 consists of all product under product code: LPH and same usage: Item no: 625004515 BONE SCREW 4.5X15 SELF-TA 625004520 BONE SCRE…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 21 consists of all product under product code: JDI and same usage: Item no: 811400218 CPT 12/14 COCR REVISION S 811400318 CPT 12/14…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 11 consists of all product under product code JDI , and same usage: Item no: 902602500 6 DEGREE COCR FEM HEAD 26 902602600 6 DEGREE…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 55 consists of all product under product code: HSB and same usage: Item no: 225900132 ONE-PIECE LAG SCREW 11MM 225900135 ONE-PIECE…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 57 consists of all product code: JDI and same usage: Item no: 763401000 PRESSFIT FEM ST FX 10 X 115 763401100 PRESSFIT FEM ST FX 11…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Quick Connects
FDA Device · Class II · 2016-03-23 · Steris - Product 67 consists of all product under product code: JDI and same usage: Item no: 785001100 VERSYS ADVOCATE CEMENTED 785001200 VERSYS ADV…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 38 consists of all product under product code: HSB and same usage: Item no: 225303255 INTERLOCKING IM SCREW LG 225303555 INTERLOCKI…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 33 consists of all product under product code: JDI and same usage: Item no: 662406515 HGP II ACETABULAR CUP BON 662406520 HGP II AC…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 69 consists of all product under product code: JDI and same usage: Item no: 785301701 VERSYS CEMENTED FEM STEM 785301521 VERSYS CEM…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 24 consists of all product under product code: HRS and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL ME…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 25 consists of all product under product code: LPH and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL ME…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 30 consists of all product under product code: KTT and same usage: Item no: 118100527 FREE-LOCK LAG SCREW, 12.7 118100535 FREE-LOCK…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 66 consists of all product under product code: JDI and same usage: Item no: 785001100 VERSYS ADVOCATE CEMENTED 785001200 VERSYS ADV…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - NuOSS Cancellous Intended for use in dental surgery
FDA Device · Class II · 2016-03-23 · Collagen Matrix - Product 36 consists of all product under product code: HSB and same usage: Item no: 225302745 INTERLOCKING IM SCREW 4.5 225303045 INTERLOCK…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Stockert Heater-Cooler 3T
FDA Device · Class II · 2016-03-23 · Sorin Group Usa - Product 7 consists of all products under product code HWC, and same usage: Item no: 47234801435 3.5MM CORT SCR X 14MM 47234801635 3.5MM COR…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 29 consists of all product under product code: LPHand same usage: Item no: 32902603800 FEMORAL HEAD +0.5 X 22 MM 32902604810 FEMORA…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver)
FDA Device · Class II · 2016-03-23 · Pro Dex - Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Model Numbers: 10091805, 10091807, 10091637, 10091673 intended f…
FDA Device · Class II · 2016-03-23 · Siemens Medical Solutions Usa - Product 9 consists of all product under HRS, and same usage: Item no: 47494502601 4.5 BROAD SCP PLT, 26 HOL Product Usage: Temporary intern…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 39 consists of all product under product code: JDI and same usage: Item no: 32902605800 ION IMPLANTED FEM 22MM LO 32902604900 ION I…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 1 consists of all product under , product code: JWH and same usage: Item no: 47481500601 1.5 X 6 CORT SCREW HEX/SE Product Usage: A…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 22 consists of all product under product code: JDI and same usage: Item no: 811400218 CPT 12/14 COCR REVISION S 811400318 CPT 12/14…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 35 consists of all product under product code: JWH and same usage: Item no: 522007300 I/B II KNEE FLUTED ROD, 1 for use in total kn…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1
FDA Device · Class II · 2016-03-23 · Mckesson Medical Immaging - Product 61 consists of all product under product code: JWH and same usage: Item no: 598003712 STD PRECOAT TIBIA PLATE S for use in total kn…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 2 consists of all products product code LPH, and same usage: 801802202 12/14 COCR FEMORAL HEAD 2 801802220 12/14 COCR FEMORAL HEAD…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 37 consists of all product under product code: HSB and same usage: Item no: 225302055 INTERLOCKING IM SCREW LG 225303055 INTERLOCKI…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 52 consists of product code: HWC and same usage: Item no: 525004530 NEXGEN OSTEOTOMY CORT BON 525004540 NEXGEN OSTEOTOMY CORT BON 5…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 27 consists of all product under product code: HSB and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL ME…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 6 consists of all products under product code HWC, and same usage: Item no: 47493501001 3.5 X 10 CORT SCREW SELFT 47493501801 3.5 X…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 49 consists of all product under product code: JWH and same usage: Item no: 597206529 NEXGEN ALL-POLY PATELLA, 597206532 NEXGEN ALL…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 44 consists of all product under product code: HWC and same usage: Item no: 114607099 MAGMA-FX CANN SCREW 7.0MM 114604099 MAGNA FX…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 18 consists of all product under product code: HWC and same usage: Item no: 47248001441 CANC SCR 4.0MM X 14MM FUL 47248001641 CANC…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 72 consists of all product code: JDI and same usage: Item no: 805002202 ZIMTRON HEAD 12/14 0X22 MM For use in total or hemi hip art…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 for use as diagnostic contact lenses for eye examinations (includin…
FDA Device · Class III · 2016-03-23 · Volk Optical - Product 41 consists of all product under product code: KTT and same usage: Item no: 119301042 LAG SCR 12.7D X 100MM STA 119301045 LAG SCR 1…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 8 consists of all products under product code HWC, and same usage: Item no: 47483501201 3.5MM CORT. SCREW 12MM LN 47483501401 3.5MM…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 71 consists of all product under product code: JDI and same usage: Item no: 783401000 VERSYS PRESS FIT LD/FX ST 783401100 VERSYS PR…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic resonance diagnostic d…
FDA Device · Class II · 2016-03-23 · Deerfield Imaging - Pilling Modular Verres Body/Obturator, Product Code 140880
FDA Device · Class II · 2016-03-23 · Teleflex Medical
Other years
2026 (2,088) · 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)