Needle, Hypodermic, Single Lumen
General Hospital · 21 CFR 880.5570
Recent MDR events
39,692 adverse event reports on file
- PEN NEEDLE AUTOSHIELD DUO 30GX5MMJul 31, 2026MalfunctionEmbecta Penel Limited - Dun Laoghaire, Ireland3023359743-2026-00080
- PrecisionGlideJul 30, 2026MalfunctionBd Medical (bd West) Medical Surgical1911916-2026-00394
- BD Vacutainer® Eclipse¿ Signal¿ Blood Collection Needle with Integrated HolderJul 30, 2026MalfunctionBecton, Dickinson And Company (bd)9617032-2026-01297
- BD Vacutainer® Eclipse¿ Signal¿ Blood Collection Needle with Integrated HolderJul 30, 2026MalfunctionBecton, Dickinson And Company (bd)9617032-2026-01298
- BD Safety Glide Needle 25g 5/8"Jul 30, 2026OtherMW6000167
- Pen Needles FGJul 29, 2026MalfunctionTrividia Health Inc1000113657-2026-00264
- BD Vacutainer® Eclipse¿ Signal¿ Blood Collection Needle with Integrated HolderJul 29, 2026MalfunctionBecton, Dickinson And Company (bd)9617032-2026-01283
- BD Vacutainer® Eclipse¿ Signal¿ Blood Collection Needle with Integrated HolderJul 29, 2026MalfunctionBecton, Dickinson And Company (bd)9617032-2026-01285
- BD Vacutainer® Eclipse¿ Signal¿ Blood Collection Needle with Integrated HolderJul 29, 2026MalfunctionBecton, Dickinson And Company (bd)9617032-2026-01284
- BD Vacutainer® Eclipse¿ Signal¿ Blood Collection Needle with Integrated HolderJul 29, 2026MalfunctionBecton, Dickinson And Company (bd)9617032-2026-01294
Event type breakdown
Most-reported manufacturers
Recalls
309 recall events for this product code
- Bard Access Systems, Inc.Open, ClassifiedAug 14, 2026
BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK,
After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases, users may experience difficulty/inability to remove obturator, due to it locking to the needle hub, due to out-of-tolerance dimensions and IFU unclarity, which may result in new needle placement, which may result in delayed therapy
Z-2872-2026 · View FDA record ↗ - Waismed Ltd.Open, ClassifiedJul 17, 2025
Brand Name: NIO-A
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
Z-2118-2025 · View FDA record ↗ - Waismed Ltd.Open, ClassifiedJul 17, 2025
Brand Name: NIO+
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
Z-2119-2025 · View FDA record ↗ - Greiner Bio-One GmbHOpen, ClassifiedJan 3, 2025
VACUETTE SAFELINK, REF: 450210
The VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching up and not retracting when using the device.
Z-0802-2025 · View FDA record ↗ - Embecta Corp.Open, ClassifiedJul 23, 2024
BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Counseling Sample Toolbox -Catalog 6484755/Lot Number: 3750144)-Sterile, single use d
BD Nano 2nd Gen Pen Needle was shipped close to or after the labeled expiration date of February 29, 2024. Using a device past its expiry sterility and integrity of the device cannot be guaranteed.
Z-2424-2024 · View FDA record ↗ - Retractable Technologies, Inc.Open, ClassifiedMar 14, 2024
EasyPoint Needle, 25G x 5/8", REF: 82091
The needle cannula of a retractable needle may detach from the needle holder in the patient.
Z-1293-2024 · View FDA record ↗ - Apellis Pharmaceuticals, Inc.Open, ClassifiedSep 29, 2023
Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin
19-gauge x 1" inch filter needles showed appearances of a small fraction of non-preferred characteristics. A causal relationship has not been established between the structural variations in this 19-gauge filter needle and the rare events of retinal vasculitis
Z-2653-2023 · View FDA record ↗ - Bard Access Systems, Inc.Open, ClassifiedJul 22, 2022
Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for Powered Driver 15mm x 15Ga,
BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from intraosseous needle during placement may cause removal of the entire needle assembly and loss of intraosseous access; 2) Stylet safety mechanism may not engage as the stylet is removed; 3) Metal discs in the powered driver may stick rendering the driver unusable.
Z-1397-2022 · View FDA record ↗ - Becton Dickinson & CompanyTerminatedOct 31, 2019
BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608
BD PAS received customer complaints indicating the absence of the bevel on the non-patient needle end of the product, causing blood leakage.
Z-0252-2020 · View FDA record ↗ - Teleflex MedicalTerminatedApr 4, 2017
Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079.
Some of the individual unit packaging (pouches) may be missing the lot number an expiration date.
Z-1829-2017 · View FDA record ↗
Registered firms
1,305 firms currently registered for this product code
Vygon Mfg
DOVER, NH, US
Allison Medical, Inc.
Littleton, CO, US
Companhia Brasileira De Esterilizacao
Jarinu Sao Paulo, BR
Gemtier Medical (shanghai) Inc.
Shanghai, CN
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
Taihu Anhui, CN
Shina Med Corporation
Anseong-si Gyeonggi, KR
Synergy Health Sterilisation Uk Ltd
Daventry Northamptonshire, GB
Zhejiang Ini Medical Devices Co., Ltd
WENZHOU Zhejiang, CN
Zhejiang Huanyi Sterilization Technology Co., Ltd
huzhou Zhejiang, CN
Terumo Europe N.v.
LEUVEN Vlaams Brabant, BE
Palm Medical International Bv
Buggenhout Oost-Vlaanderen, BE
Teleflex Medical Llc
Morrisville, NC, US
Shandong Caremed Medical Products Co.,ltd.
Heze Shandong, CN
Owen Mumford Usa, Inc.
MARIETTA, GA, US
Cosmofrance
Miami, FL, US
Nipro (thailand) Corporation Limited
SENA Phra Nakhon Si Ayutthaya, TH
Rr Donnelley Global Turnkey Solutions
Juarez Chihuahua, MX
Dylan Lucas International Inc
Vaughan Ontario, CA
Arrow International C.r. A.s.
ZDAR NAD SAZAVOU Vysocina, CZ
Sterigenics Belgium Petit Rechain S.a.
Verviers Liege, BE
Terumo Medical Canada, Inc.
Vaughan Ontario, CA
Becton Dickinson, S.a.
FRAGA Huesca, ES
510(k) clearances
691 clearances for this product code
- Hangzhou Qiantang Longyue Biotechnology Co., Ltd.Aug 7, 2026
K260933 · Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)
- CMT Health PTE., Ltd.Jul 29, 2026
K261829 · Profoject Dual-Safety Pen Needles
- CMT Health PTE., Ltd.Jul 15, 2026
K260739 · Profoject Pen Needles (Model A; Model B)
- CMT Health PTE., Ltd.Jun 10, 2026
K260855 · Profoject Safety Pen Needles
- Promisemed Hangzhou Meditech Co., Ltd.Apr 16, 2026
K254273 · Verisafe Safety Sterile Needles (SSN)
- Sandstone Medical (Suzhou), Inc.Mar 25, 2026
K252908 · Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle
- Nipro Medical CorporationMar 24, 2026
K253047 · PRESSONE
- Ningbo Medsun Medical Co., Ltd.Mar 18, 2026
K253622 · Safety Pen Needle