Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
General, Plastic Surgery · 21 CFR 878.4850
A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.
Recent MDR events
14,104 adverse event reports on file
- MEDLINEJul 14, 2026MalfunctionMedline Industries, Lp1417592-2026-05220
- ONETOUCH DELICA PLUS LANCING DEVICEJul 2, 2026InjuryAsahi Polyslider Co., Ltd.3042301847-2026-00022
- NOVAPLUSJul 1, 2026MalfunctionNsp Tech Pte Ltd3008337059-2026-00001
- CARDINAL HEALTH UNISTIK 3 NORMALJun 26, 2026MalfunctionOwen Mumford Limited1058602-2026-00009
- CARDINAL HEALTH UNISTIK 3 NORMALJun 26, 2026MalfunctionOwen Mumford Limited8021764-2026-00009
- CARDINAL HEALTH UNISTIK 3 NORMALJun 10, 2026InjuryOwen Mumford Limited8021764-2026-00008
- CARDINAL HEALTH UNISTIK 3 NORMALJun 10, 2026InjuryOwen Mumford Limited1058602-2026-00008
- NOVAPLUS NEWBORNJun 3, 2026MalfunctionNsp Tech Pte, Ltd.25373524
- NOVAPLUS NEWBORNJun 3, 2026MalfunctionNsp Tech Pte, Ltd.25373585
- UNISTIK TOUCHMay 26, 2026MalfunctionOwen Mumford Limited25277096
Event type breakdown
Recalls
17 recall events for this product code
- Becton Dickinson & CompanyTerminatedSep 11, 2013
BD Microtainer Quikheel Lancet 1.0 mm incision Depth 2.5 mm Incision Length REF 368101 Rx Only Becton, Dickinson and Company, Franklin Lakes, NJ 07417 USA Made
The Lancet will not retract after activation thus creating a potential for exposure to a used sharp.
Z-2192-2013 · View FDA record ↗ - Roche Diagnostics Operations, Inc.TerminatedAug 28, 2013
ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.
Internal Roche inspections have revealed that after the lancet is used for a finger stick, the needle may not fully retract back within the lancet drum or back into the cap. This allows the needle to protrude inside the cap or outside of the cap of the ACCU-CHEK FastClix lancing device.
Z-2109-2013 · View FDA record ↗ - KooJoo Trading CompanyTerminatedJul 13, 2013
Safety Lancets - Odyssey, Button Activated;
Lancets were not sterilized within the dose range established by sterilization validation.
Z-1729-2013 · View FDA record ↗ - Roche Diagnostics Corp.TerminatedAug 11, 2009
Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Models 3144844001 (10 lancets) and 3583031002 (17 lancets).
The lancet cap may be missing, which could result in an unintended lancet stick to the user.
Z-1590-2009 · View FDA record ↗ - Facet TechnologiesTerminatedOct 27, 2008
Premier Value Lancing Device. UPC Code: 840986016707, The Package Includes: 1 Lancing Device, 1 Clear Cap and 5 Premier Value Ultra Thin Lancets, Distributed by
The Alternate Site Cap was not included in the package as indicated on the labeling.
Z-0174-2009 · View FDA record ↗ - Sarstedt IncTerminatedOct 14, 2008
Safety Lancet for capillary blood sampling, 1.6 mm x 28G, Mini, Sarstedt. (Blood lancet)
The product from this lot may not retract the lancet into the safe position inside the lancet body after the trigger is actuated.
Z-0114-2009 · View FDA record ↗ - Becton Dickinson & CompanyTerminatedOct 18, 2007
Microtainer Safety Flow Lancets; Green
Potential for the blade and holder assembly to become loose and then separate from the main body of the lancet during the process of disposal.
Z-0044-2008 · View FDA record ↗ - Lifescan IncTerminatedAug 16, 2007
One Touch SureSoft Lancing Device in carton. Part Number 021-140-01, aka OT SureSoft Hospital, Gentle 200
Lancet tip may not fully retract and cause needle stick and exposure to used lancets.
Z-1165-2007 · View FDA record ↗ - Hawaii Medical LLCTerminatedJun 9, 2007
NeatNick Sweeping Action Heel Lancet -Full-Term-
Lancet may misfire and an inadequate blood sample may result; additionally, the blade may not retract after use and result in a needle stick to the user/patient
Z-0926-2007 · View FDA record ↗ - Hawaii Medical LLCTerminatedJun 9, 2007
NeatNick Sweeping Action Heel Lancet - Preemie-
Lancet may misfire and an inadequate blood sample may result; additionally, the blade may not retract after use and result in a needle stick to the user/patient
Z-0927-2007 · View FDA record ↗
Registered firms
257 firms currently registered for this product code
Owen Mumford Sdn Bhd
Iskandar Puteri Johor, MY
Hochuen Medical Sdn. Bhd.
SENAI Johor, MY
Tianjin Huahong Technology Co., Ltd.
Tianjin, CN
Acon Biotech (hangzhou) Co., Ltd.
HANGZHOU Zhejiang, CN
Toc Logistics / Sol-millenium Canada, Inc.
Balzac Alberta, CA
Htl-strefa S.a.
OZORKOW Lodzkie, PL
Letsgetchecked Inc
City View Heights, OH, US
Taizhou Chenguang Import And Export Trading Co., Ltd.
Taizhou Jiangsu, CN
Sterilance Medical (suzhou) Inc.
Suzhou Jiangsu, CN
Pt Nsp Technology Batam
Batu Ampar Riau, ID
Owen Mumford Usa, Inc.
MARIETTA, GA, US
Asahi Polyslider Company, Limited Okayama-kuse Plant
Maniwa Okayama, JP
Privapath Diagnostics Ltd
Dublin 11, IE
Mhc Medical Products
Fairfield, OH, US
Tianjin Jpy Ion-tech. Co., Ltd.
TIANJIN, CN
Genteel, Llc
West Linn, OR, US
Cbr Enterprise Limited
Hong Kong, HK
Lotfancy Inc
Ontario, CA, US
Abbott Diabetes Care Inc.
ALAMEDA, CA, US
Synergy Health Ede Bv
Venlo Limburg, NL
Saris And Things, Inc.
Plainfield, IL, US
510(k) clearances
110 clearances for this product code
- Promisemed Hangzhou Meditech Co., Ltd.May 1, 2026
K261045 · Verifine Safety Lancets
- Tianjin Huahong Technology Co., Ltd.Mar 31, 2026
K260191 · Safety lancet (XXXVII)
- Ningbo Medsun Medical Co., Ltd.Feb 20, 2026
K253605 · Safety Heel Lancet
- Tianjin Huahong Technology Co., Ltd.Feb 12, 2026
K252490 · Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)
- Tianjin Huahong Technology Co., Ltd.Jun 26, 2025
K251694 · safety lancet
- SteriLance Medical (Suzhou), Inc.Feb 26, 2025
K244036 · Heel Incision Safety Lancet (SteriHeel 2)
- Privapath Diagnostics Ltd (Dba Letsgetchecked)Jan 13, 2025
K242680 · LetsGetChecked Impress
- Hlb Co., Ltd. HealthcareJan 13, 2025
K243533 · Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus