Biopsy Needle
FDA product code FCG · Class II (moderate risk) · 21 CFR 876.1075 · Gastroenterology, Urology
133510(k) clearances
0PMA approvals
52recalls
Manufacturers
- Cook Ireland, Ltd. 7
- Medi-Globe Corp. 7
- Olympus Medical Systems Corp. 7
- Wilson-Cook Medical, Inc. 5
- Boston Scientific Corporation 5
- H.S. Hospital Services S.P.A. 4
- Promex, Inc. 4
- H.S. Hospital Service S.R.L. 4
- A.D.T. Lab Industries 3
- Proact, Ltd. 3
- Promedical , Ltd. 3
- Gallini Intl., Inc. 3
- Finemedix Co., Ltd. 3
- Olympus America, Inc. 3
- Amedic USA 2
- United States Endoscopy Group, Inc. 2
- Popper & Sons, Inc. 2
- Sherwood Medical Co. 2
- Ferguson Medical 2
- Core Medical, Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252646 | Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)FCG · Traditional | Olympus Medical Systems Corp. | 10/24/2025SE |
| K250994 | ClearTip FNA and FNB TypesFCG · Traditional | Finemedix Co., Ltd. | 08/21/2025SE |
| K241209 | EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19)FCG · Traditional | Cook Ireland, Ltd. | 07/29/2024SE |
| K231422 | Precision GIFCG · Traditional | Limaca Medical, Ltd. | 08/28/2023SE |
| K231267 | ClearTipFCG · Traditional | Finemedix Co., Ltd. | 06/30/2023SE |
| K230909 | EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22)FCG · Traditional | Cook Ireland, Ltd. | 05/30/2023SE |
| K212423 | EndoDrill® Model XFCG · Traditional | Bibbinstruments AB | 03/29/2023SE |
| K212822 | Disposable Coaxial Biopsy NeedleFCG · Traditional | Suzhou Leapmed Healthcare Corporation | 07/06/2022SE |
| K212819 | Disposable Biopsy Refill NeedleFCG · Traditional | Suzhou Leapmed Healthcare Corporation | 07/06/2022SE |
| K210476 | EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…FCG · Traditional | Cook Ireland, Ltd. | 05/20/2021SE |
| K191472 | Biopsy NeedleFCG · Traditional | Ushare Medical, Inc. | 01/29/2020SE |
| K181756 | Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial NeedleFCG · Traditional | Apriomed AB | 12/18/2018SE |
| K180668 | Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025NFCG · Traditional | Olympus Medical Systems Corp. | 11/15/2018SE |
| K180363 | Clear-Tip EUS-FNAFCG · Traditional | Finemedix Co., Ltd. | 11/01/2018SE |
| K181994 | Single Use Aspiration Needle NA-U201HFCG · Traditional | Olympus Medical Systems Corp. | 10/31/2018SE |
| K180449 | Single Use Aspiration Needle NA-U200HFCG · Traditional | Olympus Medical Systems Corp. | 06/08/2018SE |
| K180037 | Beacon EUS Access SystemFCG · Traditional | Covidien, LLC | 04/26/2018SE |
| K171956 | Sterile Endoscope Biopsy Sampling NeedleFCG · Traditional | Changzhou Detain Medical Devices Co., Ltd. | 12/12/2017SE |
| K171596 | ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound NeedleFCG · Traditional | Wilson-Cook Medical, Inc. | 08/04/2017SE |
| K160890 | Howell Biliary Introducer NeedleFCG · Traditional | Wilson-Cook Medical, Inc. | 06/14/2017SE |
| K160423 | Perineologic Access NeedleFCG · Traditional | Corbin Clinical Resources, LLC | 09/02/2016SE |
| K160098 | Single Use Aspiration Needle NA-U401SXFCG · Traditional | Olympus Medical Systems Corp. | 03/22/2016SE |
| K160229 | Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore…FCG · Traditional | Cook Ireland, Ltd. | 03/21/2016SE |
| K151738 | Single Use Aspiration Needle NA-U200HFCG · Traditional | Olympus Medical Systems Corp. | 11/20/2015SE |
| K151895 | Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleFCG · Traditional | Boston Scientific Corporation | 10/22/2015SE |
| K151373 | Corvocet Coaxial IntroducerFCG · Traditional | Merit Medical Systems, Inc. | 08/07/2015SE |
| K150891 | BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy SystemFCG · Special | Covidien, LLC( Formerly Beacon Endoscopic Corp.) | 05/01/2015SE |
| K142688 | Echotip Procore HD Ultrasound Biopsy NeedleFCG · Traditional | Cook Ireland, Ltd. | 12/19/2014SE |
| K131925 | HS NotaFCG · Traditional | H.S. Hospital Services S.P.A. | 10/10/2014SE |
| K141894 | Sharkcore Fine Needle Biopsy SystemFCG · Traditional | Covidien, LLC( Formerly Beacon Endoscopic Corp.) | 10/06/2014SE |
| K133763 | Sonotip Pro and Pro Flex Ebus-Tbna Needle SystemFCG · Traditional | Medi-Globe Corporation | 05/15/2014SE |
| K140137 | Safety Biopsy Needle SystemFCG · Traditional | Pfm Medical, Inc. | 03/25/2014SE |
| K133008 | BNX Delivery System Pre-Loaded with 19, 22 and 25 Gauge Needle, 19, 22 or 25 Gauge…FCG · Traditional | Beacon Endoscopic | 11/20/2013SE |
| K103694 | Tissue Sampling NeedleFCG · Traditional | United States Endoscopy Group, Inc. | 07/27/2011SE |
| K103668 | BNX Fine Needle Aspiration SystemFCG · Traditional | Boston Endoscopic Engineering | 12/30/2010SE |
| K100712 | Resound Endoscopic Ultrasound Aspiration NeedleFCG · Traditional | Boston Scientific Corporation | 03/30/2010SE |
| K093195 | Echotip Ultra Endobronchial High Definition Ultasound Needle, Model: ECHO-HD-22-EBUS-OFCG · Traditional | Cook Ireland, Ltd. | 01/21/2010SE |
| K092359 | Echo Tip Ultra High Definition Ultrasound Access Needle, Model: ECHO-HD-19AFCG · Traditional | Cook Ireland, Ltd. | 11/02/2009SE |
| K091257 | Medi-Globe Sonotip II Ebus-Tbna Needle SystemFCG · Traditional | Medi-Globe Corporation | 05/08/2009SE |
| K083802 | Sonotip II 25-GAUGE Ultrasound Needle System, Models GUS-01-18-025 and GUS-01-27-025FCG · Traditional | Medi-Globe Corporation | 03/20/2009SE |
| K083330 | Echotip Ultra Ultrasound NeedleFCG · Traditional | Cook Endoscopy | 02/06/2009SE |
| K081323 | Biopsy Guide Kit for 8808 and Biplane, Endfire and Dual Biopsy Guides for 8818FCG · Traditional | B-K Medical Aps | 07/22/2008SE |
| K073399 | Targetscan Biopsy Kit, Targetscan Biopsy Needle GuideFCG · Special | Envisioneering, LLC | 12/21/2007SE |
| K062979 | ThyrosamplerFCG · Traditional | Acd Medical Innovation Corp. | 05/30/2007SE |
| K070179 | Trokabone, Trokabone SternalFCG · Traditional | PAJUNK GmbH Medizintechnologie | 03/07/2007SE |
| K070129 | Sonotip II Ultrasound Needle SystemFCG · Traditional | Medi-Globe Corporation | 01/31/2007SE |
| K051506 | Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut - Soft…FCG · Traditional | Sterylab S.R.L. | 07/27/2005SE |
| K050135 | K-C Hemostatic Biopsy SystemFCG · Traditional | Bioengineering Consultants , Ltd. | 07/13/2005SE |
| K051247 | Sonotip II Ultrasound Needle SystemFCG · Special | Medi-Globe Corp. | 06/16/2005SE |
| K050503 | Single Use Aspiration Needle NA-201SX-4022FCG · Traditional | Olympus Medical Systems Corporation | 05/12/2005SE |
| K050120 | Easy Core Biopsy System IIFCG · Special | Boston Scientific Corp | 02/08/2005SE |
| K040893 | Easy Core Biopsy SystemFCG · Special | Boston Scientific Corp | 05/06/2004SE |
| K024120 | Modification to Temno Biopsy NeedlesFCG · Special | Allegiance Healthcare Corp. | 01/15/2003SE |
| K023272 | Disposable Aspiration Needle NA-200HFCG · Traditional | The Olympus Optical Co. | 12/23/2002SE |
| K021847 | Biopsy Sciences, LLC Maxi-Cell Biopsy NeedlesFCG · Traditional | Biopsy Sciences, LLC | 09/03/2002SE |
| K021525 | TopcutFCG · Traditional | H.S. Hospital Service S.R.L. | 07/12/2002SE |
| K013109 | SonopsyFCG · Traditional | Hakko Medical Co., Ltd. | 03/12/2002SE |
| K013071 | Securcut Aspiration Biopsy NeedleFCG · Traditional | H.S. Hospital Services S.P.A. | 12/12/2001SE |
| K013070 | Jamshidi Biopsy NeedleFCG · Traditional | H.S. Hospital Services S.P.A. | 12/12/2001SE |
| K013069 | BiospeedFCG · Traditional | H.S. Hospital Services S.P.A. | 12/12/2001SE |
| K012864 | Interject Injection Therapy Needle, Models 1810, 1811, 1815, 1816, 1820, 1821, 1825…FCG · Traditional | Boston Scientific Corp | 10/24/2001SE |
| K013356 | Wilson-Cook Ultrasound Biopsy NeedleFCG · Special | Wilson-Cook Medical, Inc. | 10/19/2001SE |
| K012358 | Chiba NeedleFCG · Traditional | Ispg, Inc. | 10/15/2001SE |
| K011075 | EasybellFCG · Traditional | Biopsybell S.A.S. | 06/27/2001SE |
| K011270 | Automated Core Biopsy DeviceFCG · Traditional | Promex, Inc. | 06/22/2001SE |
| K002947 | Biomol Aspiration Biopsy NeedleFCG · Traditional | H.S. Hospital Service S.R.L. | 12/19/2000SE |
| K002946 | Silent Biopsy NeedleFCG · Traditional | H.S. Hospital Service S.R.L. | 12/19/2000SE |
| K002944 | Precisa Biopsy NeedleFCG · Traditional | H.S. Hospital Service S.R.L. | 12/19/2000SE |
| K991672 | Olympus NA-10J-KB Aspiration NeedleFCG · Traditional | Olympus America, Inc. | 11/03/1999SE |
| K990220 | Modification of Gip/Medi-Globe Ultrasound Needle SystemFCG · Traditional | Medi-Globe Corp. | 03/31/1999SE |
| K983218 | N,I.T., Inc. Automatic Cutting Biopsy NeedleFCG · Traditional | Avid N.I.T., Inc. | 11/06/1998SE |
| K981889 | Worldwide Medical Technologies Introducer NeedleFCG · Traditional | Worldwide Medical Technologies, LLC | 07/31/1998SE |
| K963565 | MRI NeedlesFCG · Traditional | Cook, Inc. | 07/14/1997SE |
| K971842 | Coaxial NeedleFCG · Traditional | United States Endoscopy Group, Inc. | 06/20/1997SE |
| K970563 | Olympus NA-10J-1 Aspiration NeedleFCG · Traditional | Olympus America, Inc. | 04/11/1997SE |
| K963894 | SmartguideFCG · Traditional | Ferguson Medical | 03/11/1997SE |
| K961897 | Wilson-Cook Biliary Introducer with Aspiration Biopsy NeedleFCG · Traditional | Wilson-Cook Medical, Inc. | 01/29/1997SE |
| K962570 | Isan Sternal-Iliac Aspiration Biopsy NeedleFCG · Traditional | Gallini Intl., Inc. | 11/27/1996SE |
| K962569 | Biomid Bone Marrow Biopsy NeedleFCG · Traditional | Gallini Intl., Inc. | 11/27/1996SE |
| K962568 | Acri Iliac Crest Aspiration Biopsy NeedlesFCG · Traditional | Gallini Intl., Inc. | 11/25/1996SE |
| K962905 | TX Biopsy NeedleFCG · Traditional | Gallini S.R.L. | 10/11/1996SE |
| K961185 | Daum BiopsyneedleFCG · Traditional | Ferguson Medical | 04/30/1996SE |
| K960317 | Laurus Needle Core Biopsy SystemFCG · Traditional | Laurus Medical Corp. | 03/15/1996SE |
| K943304 | 3D Surgical Endoscopy System for UrologyFCG · Traditional | Olympus America, Inc. | 12/20/1995SE |
| K951421 | Global Medical Products Chiba, Franseen, Westcott Style, Menghini, Turner, Greene NeedlesFCG · Traditional | Global Medical Products, Ltd. | 11/16/1995SE |
| K954596 | Pro-B Core-Rect Coaxial Biopsy SystemFCG · Traditional | Promedical , Ltd. | 10/07/1995SE |
| K954231 | Augastroenterology-Urology Biopsy InstrumentFCG · Traditional | Promex, Inc. | 09/22/1995SE |
| K954155 | Greene, Turner, Menghini Style Aspiration Biopsy NeedleFCG · Traditional | Promex, Inc. | 09/12/1995SE |
| K941722 | Fna Biopsy NeedleFCG · Traditional | Betta Medical, Inc. | 05/22/1995SE |
| K951598 | Pro-B Biopsy NeedleFCG · Traditional | Promedical , Ltd. | 04/21/1995SE |
| K950982 | B. Braun Sonocan Biopsy Needle and Aspiration HandleFCG · Traditional | B. Braun of America, Inc. | 04/04/1995SE |
| K950810 | Rutner Biopsy DeviceFCG · Traditional | Cook Urological, Inc. | 03/06/1995SE |
| K935844 | Gip/Medi-Globe Needle System for Ultrasonic FnaFCG · Traditional | Medi-Globe Corp. | 02/13/1995SE |
| K945813 | Becton Dickinson Precision Cut(Tm) Coaxial Introducer Needle with Depth StopFCG · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 02/07/1995SE |
| K945921 | Echo Star Needle SetFCG · Traditional | Ideamatrix | 02/01/1995SE |
| K945146 | Chiba, Franseen, Westcott, Spinal Style Aspiration Biopsy NeedleFCG · Traditional | Promex, Inc. | 12/21/1994SE |
| K944944 | Chiba, Franseen, Westcott, Spinal Style Aspiration Biopsy NeedleFCG · Traditional | Promedical , Ltd. | 12/21/1994SE |
| K945133 | Modified Biopsy NeedleFCG · Traditional | Biopsys Medical, Inc. | 11/09/1994SE |
| K941563 | The Biopsy ToolFCG · Traditional | Citation Medical Corp. | 09/26/1994SE |
| K934256 | Global Medical Cutting Biopsy NeedleFCG · Traditional | Global Medical Prods, Inc. | 03/28/1994SE |
| K936194 | Coaxial Biopsy NeedleFCG · Traditional | Bard Gynecology and Radiology | 03/22/1994SE |
| K915801 | Bip-Coax-SystemFCG · Traditional | Uni-Quatro Industries Canada, Inc. | 03/11/1994SE |
| K934370 | Bip Biopsy Needle ModificationFCG · Traditional | Bip USA, Inc. | 03/07/1994SE |
| K934356 | Wilson-Cook Gi Aspiration NeedleFCG · Traditional | Wilson-Cook Medical, Inc. | 01/07/1994SE |
| K926559 | Proact Biopsy Needle EnchancementsFCG · Traditional | Proact, Ltd. | 03/22/1993SE |
| K924271 | Chiba/Franseen/Westcott/Spinal Style NeedlesFCG · Traditional | Core Medical, Inc. | 11/23/1992SE |
| K914732 | Core Medical Biopsy NeedleFCG · Traditional | Core Medical, Inc. | 01/07/1992SE |
| K910720 | Bard Biopty-Cut Biopsy Needle with SpacerFCG · Traditional | C.R. Bard, Inc. | 06/10/1991SE |
| K911397 | Hypodermic Needles, Single LumenFCG · Traditional | Popper & Sons, Inc. | 05/20/1991SE |
| K905556 | High Speed Core Cut Biopsy GunFCG · Traditional | Uni-Quatro Industries Canada, Inc. | 03/08/1991SE |
| K902320 | Bauer Flexi-Temno Biopsy NeedleFCG · Traditional | Proact, Ltd. | 10/01/1990SE |
| K902319 | Bauer Temno Biopsy NeedleFCG · Traditional | Proact, Ltd. | 09/06/1990SE |
| K896932 | Ingress Technologies Auto BX Biopsy NeedleFCG · Traditional | The Witmoore Group, Inc. | 06/22/1990SE |
| K895725 | Biopsy Needle Guide for Adms Ultrasound ProbesFCG · Traditional | Interson Corp. | 11/06/1989SE |
| K895897 | Manan Prostatic Biopsy NeedleFCG · Traditional | Manan Medical Products, Inc. | 10/18/1989SE |
| K892068 | TRT (Acuson) Needle Guide Kit, SterileFCG · Traditional | Amedic USA | 08/04/1989SE |
| K891777 | Pro-Cut Biopsy NeedleFCG · Traditional | Teknar, Inc. | 05/04/1989SE |
| K890327 | Biopsy Needle Guide AttachmentFCG · Traditional | Elscint, Inc. | 03/08/1989SE |
| K890203 | Adms Biopsy NeedleFCG · Traditional | Advanced Diagnostic Medical Systems, Inc. | 03/08/1989SE |
| K882549 | Acuson Transrectal Needle Guide for Intra. Appli.FCG · Traditional | Acuson Corp. | 07/21/1988SE |
| K871467 | Biopsy Needle Guide Kit, SterileFCG · Traditional | Amedic USA | 08/21/1987SE |
| K854404 | Rotex Screw Biopsy NeedleFCG · Traditional | Meadox Surgimed, Inc. | 12/02/1985SE |
| K854289 | Medsurg Ultrasound Biopsy TrayFCG · Traditional | Medsurg Industries, Inc. | 11/26/1985SE |
| K844993 | Cohen-Warner Testicular Biopsy Tray 2N2720FCG · Traditional | Omnis Surgical, Inc. | 02/28/1985SE |
| K840144 | Yag Laser 8000 Gastrointestinal BleeFCG · Traditional | Cooper Medical Corp. | 05/18/1984SE |
| K840354 | Monoject Soft Tissue Biopsy/Fine NeedleFCG · Traditional | Sherwood Medical Co. | 03/12/1984SE |
| K840168 | Westerman-Jensen Biopsy NeedleFCG · Traditional | Popper & Sons, Inc. | 03/12/1984SE |
| K840157 | Millereisen Curved Biopsy NeedleFCG · Traditional | Preventive Medicine Institute | 03/12/1984SE |
| K834249 | Monoject Soft Tissue Biopsy NeedleFCG · Traditional | Sherwood Medical Co. | 03/12/1984SE |
| K800420 | Adt Percutaneous Non-Disp. NeedleFCG · Traditional | A.D.T. Lab Industries | 03/25/1980SE |
| K800419 | Adt Percutaneous Transhepatic Disp. CholFCG · Traditional | A.D.T. Lab Industries | 03/25/1980SE |
| K800416 | Adt Disposable Thin Needle(Skinny Chiba)FCG · Traditional | A.D.T. Lab Industries | 03/25/1980SE |
| K771108 | Needle, Chiba UniversityFCG · Traditional | Johannah Medical Services, Inc. | 07/29/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3206-2024 Class II | BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616…Due to possible packaging damage (indentations/cuts) cause by manufacturing process. As a result of the… | Bard Peripheral Vascular Inc | 08/02/2024Open, Classified |
| Z-3003-2024 Class II | Medline Convenience kits labeled as: 1) NHP BREAST BIOPSY PACK, Pack Number DYNJ17400B…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 04/08/2024Open, Classified |
| Z-1833-2024 Class II | EchoTip Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520Devices may contain elevated levels of bacterial endotoxin. | Cook Medical Incorporated | 04/01/2024Open, Classified |
| Z-1832-2024 Class II | EchoTip Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012Devices may contain elevated levels of bacterial endotoxin. | Cook Medical Incorporated | 04/01/2024Open, Classified |
| Z-1616-2023 Class III | To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA)…Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and… | Olympus Corporation of the Americas | 03/31/2023Open, Classified |
| Z-1615-2023 Class III | ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for…Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and… | Olympus Corporation of the Americas | 03/31/2023Open, Classified |
| Z-1600-2022 Class II | MERIT MEDICAL SYSTEMS Temno Soft Tissue Biopsy Device Temno 14 Gauge 6 cm Length Beveled…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | Mckesson Medical-Surgical Inc. Corporate… | 05/25/2022Open, Classified |
| Z-1069-2021 Class II | NA-200H-8022 22G EZSHOT ASPIRATION NEEDLE, model no. NA-200H-8022 - Product Usage: Used…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | Aomori Olympus Co., Ltd. | 01/04/2021Terminated |
| Z-1062-2021 Class II | NA-201SX-4022-C ASPIRATION NEEDLE ViziShot 22G w/o stylet, model no. NA-201SX-4022-C -…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | Aomori Olympus Co., Ltd. | 01/04/2021Terminated |
| Z-1061-2021 Class II | NA-201SX-4022-B ASPIRATION NEEDLE ViziShot 22G, model no. NA-201SX-4022-B - Product…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | Aomori Olympus Co., Ltd. | 01/04/2021Terminated |
| Z-1060-2021 Class II | NA-201SX-4022-ASPIRATION NEEDLE VIZISHOT 22G, model no. NA-201SX-4022-A - Product Usage:…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | Aomori Olympus Co., Ltd. | 01/04/2021Terminated |
| Z-1059-2021 Class II | NA-201SX-4021 ASPIRATION NEEDLE VIZISHOT 21G, model no. NA-201SX-4021 - Product Usage:…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | Aomori Olympus Co., Ltd. | 01/04/2021Terminated |
| Z-2769-2020 Class II | Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use…This voluntary recall is being conducted following three customer reports of the device cannula detaching… | Covidien Llc | 06/26/2020Open, Classified |
| Z-2768-2020 Class II | Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use…This voluntary recall is being conducted following three customer reports of the device cannula detaching… | Covidien Llc | 06/26/2020Open, Classified |
| Z-1476-2017 Class II | BNX Fine Need Aspiration System (22GA); Material/Part#: DSN-22-01Handle may break during use. | Medtronic | 02/08/2017Terminated |
| Z-1475-2017 Class II | SharkCore LG Fine Needle Biopsy System (19GA); Material/Part#: DSL-19-01Handle may break during use. | Medtronic | 02/08/2017Terminated |
| Z-1474-2017 Class II | SharkCore Fine Needle Biopsy System (25GA); Material/Part#: DSC-25-01Handle may break during use. | Medtronic | 02/08/2017Terminated |
| Z-1473-2017 Class II | SharkCore Fine Needle Biopsy System (22 GA); Material/Part #s: DSC-22-01Handle may break during use. | Medtronic | 02/08/2017Terminated |
| Z-1472-2017 Class II | BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01Handle may break during use. | Medtronic | 02/08/2017Terminated |
| Z-2547-2016 Class II | Bard TruGuide Disposable Coaxial Biopsy Needle Mixed Product Part Number C1816B The…May contain two trocar tip stylets with coaxials or two blunt tip stylets instead of one of each. | Bard Peripheral Vascular Inc | 07/06/2016Terminated |
| Z-2618-2016 Class II | Liver Access and Biopsy Needle Set Biopsy needle kit Intended for use in obtaining liver…Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.… | Cook Inc. | 04/15/2016Terminated |
| Z-1396-2016 Class II | Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: The TruGuide Disposable…Bard Peripheral Vascular, Inc. is recalling Bard TruGuide Disposable Coaxial Biopsy Needles because they… | Bard Peripheral Vascular Inc | 02/04/2016Terminated |
| Z-0029-2012 | OLYMPUS ViziShot EBUS Aspiration Needle Endobronchial Ultrasound (EBUS) Needle for Fine…Firm has received complaints from users of the ability to wipe material from the needle's stylet and the… | Olympus America Inc. | 08/25/2011Terminated |
| Z-3215-2011 | Boston Scientific 25ga (0.52mm) Expect Endoscopic Ultrasound Aspiration Needle REF 5002…The firm has determined that a single lot of 25 ga Expect EUS/FNA devices were mislabeled. The carton label… | Boston Scientific Corporation | 08/11/2011Terminated |
| Z-0812-2011 | Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, 25GA (0.52 mm)…The firm has received a high number of complaints related to difficulty advancing and/or retracting the… | Boston Scientific Corporation | 10/20/2010Terminated |
| Z-0811-2011 | Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, 22GA (0.72 mm)…The firm has received a high number of complaints related to difficulty advancing and/or retracting the… | Boston Scientific Corporation | 10/20/2010Terminated |
| Z-0810-2011 | Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, Single Pack, 25GA…The firm has received a high number of complaints related to difficulty advancing and/or retracting the… | Boston Scientific Corporation | 10/20/2010Terminated |
| Z-0809-2011 | Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, Single Pack, 22GA…The firm has received a high number of complaints related to difficulty advancing and/or retracting the… | Boston Scientific Corporation | 10/20/2010Terminated |
| Z-0276-2010 | Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1620. Bard Magnum…The recall was initiated after the firm determined that some Magnum Disposable Biopsy Core Needle 16 gauge… | Bard Peripheral Vascular Inc | 10/08/2009Terminated |
| Z-0275-2010 | Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1616. Bard Magnum…The recall was initiated after the firm determined that some Magnum Disposable Biopsy Core Needle 16 gauge… | Bard Peripheral Vascular Inc | 10/08/2009Terminated |
| Z-0274-2010 | Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1613. Bard Magnum…The recall was initiated after the firm determined that some Magnum Disposable Biopsy Core Needle 16 gauge… | Bard Peripheral Vascular Inc | 10/08/2009Terminated |
| Z-0273-2010 | Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1610. Bard Magnum…The recall was initiated after the firm determined that some Magnum Disposable Biopsy Core Needle 16 gauge… | Bard Peripheral Vascular Inc | 10/08/2009Terminated |
| Z-0141-2010 | Cardinal Health, Craig Calibrated Cannula, overall length 5-3/8" (13.7 cm), catalog…The Craig Calibrated Cannula does not interface with the toothed cutter properly, which may prevent the… | Cardinal Health | 08/28/2009Terminated |
| Z-0495-2009 | Boston Scientific Easy Core Biopsy System, 18 ga. x 15 cm, sterile, latex free. Boston…These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. | Boston Scientific Corp | 10/17/2008Terminated |
| Z-0494-2009 | Boston Scientific Easy Core Biopsy System, 15 ga. x 15 cm, sterile, latex free. Boston…These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. | Boston Scientific Corp | 10/17/2008Terminated |
| Z-0493-2009 | Boston Scientific TruPath Biopsy Device, 18 ga. x 21 cm, sterile, latex free. Boston…These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. | Boston Scientific Corp | 10/17/2008Terminated |
| Z-0492-2009 | Boston Scientific TruPath Biopsy Device, 18 ga. x 15 cm, sterile, latex free. Boston…These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. | Boston Scientific Corp | 10/17/2008Terminated |
| Z-0491-2009 | Boston Scientific TruPath Biopsy Device, 18 ga. x 25 cm, sterile, latex free. Boston…These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. | Boston Scientific Corp | 10/17/2008Terminated |
| Z-0490-2009 | Boston Scientific Easy Core Biopsy Device, 18 ga. x 25 cm, sterile, latex free. Boston…These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. | Boston Scientific Corp | 10/17/2008Terminated |
| Z-0489-2009 | Boston Scientific Easy Core Biopsy Device, 15 ga. x 15 cm, sterile, latex free. Boston…These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. | Boston Scientific Corp | 10/17/2008Terminated |
| Z-0488-2009 | Boston Scientific Easy Core Biopsy Device, 18 ga. x 15 cm, sterile, latex free. Boston…These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. | Boston Scientific Corp | 10/17/2008Terminated |
| Z-0487-2009 | Boston Scientific Easy Core Biopsy Device, 18 ga. x 21 cm, sterile, latex free. Boston…These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. | Boston Scientific Corp | 10/17/2008Terminated |
| Z-0337-2009 | Boston Scientific Easy Core" Biopsy System, 18 ga. x 21 cm, REF 43-460, UPN M001434601…Boston Scientific Corporation initiated a recall of its easy Core" BIOPSY SYSTEM due to difficulty cocking… | Boston Scientific Corporation | 10/07/2008Terminated |
| Z-0336-2009 | Boston Scientific Easy Core" Biopsy System, 18 ga. x 15 cm, REF 43-459, UPN M001434591…Boston Scientific Corporation initiated a recall of its easy Core" BIOPSY SYSTEM due to difficulty cocking… | Boston Scientific Corporation | 10/07/2008Terminated |
| Z-0335-2009 | Boston Scientific Easy Core" Biopsy System, 18 ga. x 10 cm, REF 43-458, UPN M001434581…Boston Scientific Corporation initiated a recall of its easy Core" BIOPSY SYSTEM due to difficulty cocking… | Boston Scientific Corporation | 10/07/2008Terminated |
| Z-0334-2009 | Boston Scientific Easy Core" Biopsy System, 15 ga. x 15 cm, REF 43-457, UPN M001434571…Boston Scientific Corporation initiated a recall of its easy Core" BIOPSY SYSTEM due to difficulty cocking… | Boston Scientific Corporation | 10/07/2008Terminated |
| Z-0333-2009 | Boston Scientific Easy Core" Biopsy System, 15 ga. x 10 cm, REF 43-456, UPN M001434561…Boston Scientific Corporation initiated a recall of its easy Core" BIOPSY SYSTEM due to difficulty cocking… | Boston Scientific Corporation | 10/07/2008Terminated |
| Z-0332-2009 | Boston Scientific Easy Core" Biopsy System, 18 ga. x 21 cm, REF 43-454, UPN M001434541…Boston Scientific Corporation initiated a recall of its easy Core" BIOPSY SYSTEM due to difficulty cocking… | Boston Scientific Corporation | 10/07/2008Terminated |
| Z-0331-2009 | Boston Scientific Easy Core" Biopsy System, 18 ga. x 15 cm, REF 43-453 , M001434531…Boston Scientific Corporation initiated a recall of its easy Core" BIOPSY SYSTEM due to difficulty cocking… | Boston Scientific Corporation | 10/07/2008Terminated |
| Z-0330-2009 | Boston Scientific Easy Core" Biopsy System, 15 ga. x 15 cm, REF 43-451, UPN M001434511…Boston Scientific Corporation initiated a recall of its easy Core" BIOPSY SYSTEM due to difficulty cocking… | Boston Scientific Corporation | 10/07/2008Terminated |