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Biopsy Needle
FDA product code FCG · Class 2 · Gastroenterology, Urology
1,581
Registered devices
4,892
Adverse events
54
Recalls
133
510(k) clearances
Devices with this code
MAGNUM — Bard Peripheral Vascular, Inc.SonoTip® EBUS Pro — Medi-Globe GmbHMIELO-CAN ILIAC — STERYLAB SRLTEMNO® — Merit Medical Systems, Inc.PRECISA — H.S. HOSPITAL SERVICE SPATEMNO Evolution® — Merit Medical Systems, Inc.Biopsybell — BIOPSYBELL SRLBIOPTY-CUT — Bard Peripheral Vascular, Inc.Biopsybell — BIOPSYBELL SRLCOMPLETE-CHIBA — STERYLAB SRLBIOPSYBELL SRL — BIOPSYBELL SRLTEMNO — CAREFUSION 2200, INCSemiCut — M.D.L. S.R.L.Leapmed — Suzhou Leapmed Healthcare CorporationMedline Industries, Inc. — MEDLINE INDUSTRIES, INC.SemiCut Coax. — M.D.L. S.R.L.Trident(TM) Adapt Endoscopic Ultrasound Biopsy Needle(FNB) — Micro-Tech (Nanjing) Co., Ltd.FULL-OPTY — STERYLAB SRLTEMNO EVOLUTION — CAREFUSION 2200, INCBiopsybell — BIOPSYBELL SRLFAST-CUT — STERYLAB SRLNA — US EndoscopyMedline Industries, Inc. — MEDLINE INDUSTRIES, INC.PRECISA — H.S. HOSPITAL SERVICE SPA
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-08-02 | Bard Peripheral Vascular Inc | Due to possible packaging damage (indentations/cuts) cause by manufacturing process. As a result of the packaging damage, may cause the sterile barrier to be c |
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee |
| 2024-04-01 | Cook Medical Incorporated | Devices may contain elevated levels of bacterial endotoxin. |
| 2024-04-01 | Cook Medical Incorporated | Devices may contain elevated levels of bacterial endotoxin. |
| 2023-03-31 | Olympus Corporation of the Americas | Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance exp |
| 2023-03-31 | Olympus Corporation of the Americas | Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance exp |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lot |
| 2021-01-04 | Aomori Olympus Co., Ltd. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equ |
| 2021-01-04 | Aomori Olympus Co., Ltd. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equ |
| 2021-01-04 | Aomori Olympus Co., Ltd. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equ |
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