Needle, Suturing, Disposable
General, Plastic Surgery · 21 CFR 878.4800
Recent MDR events
559 adverse event reports on file
- RICHARD-ALLAN® NEEDLE 1/2 CIRCLE TAPERJul 22, 2026MalfunctionAspen Surgical Products, Inc.25904376
- NEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT .050X0.897 STERILEJul 8, 2026MalfunctionAspen Surgical Products, Inc.3002750084-2026-00071
- QUATTRO SUTURE PASSER NEEDLEJul 7, 2026MalfunctionCayenne Medical3006108336-2026-00015
- NEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT .050X1.248 STERILEJul 7, 2026MalfunctionAspen Surgical Products, Inc.3002750084-2026-00069
- NEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT .050X1.521Jun 30, 2026MalfunctionAspen Surgical Products, Inc.3002750084-2026-00066
- QUATTRO SUTURE PASSER NEEDLEJun 30, 2026MalfunctionCayenne Medical3006108336-2026-00014
- QUATTRO SUTURE PASSER NEEDLEJun 23, 2026MalfunctionCayenne Medical3006108336-2026-00013
- RICHARD-ALLAN® NEEDLE 1/2 CIRCLE TAPERJun 8, 2026MalfunctionAspen Surgical Products, Inc.25426904
- VERSIPASS NEEDLEJun 8, 2026MalfunctionLincotek Medical Llc3010039400-2026-00003
- QUATTRO SUTURE PASSER NEEDLEMay 15, 2026MalfunctionCayenne Medical3006108336-2026-00009
Event type breakdown
Recalls
7 recall events for this product code
- Biomet, Inc.TerminatedApr 6, 2011
REF 906764, CURVTEK EYE NEEDLE, 12 MM LARGE, STAINLESS STEEL GAMMA STERILIZED, PKG/3, BIOMET SPORTS MEDICINE, 56 EAST BELL DRIVE, P.O. BOX 587, WARSAW, IN 46581
The firm initiated a recall due to the discovery that the devices were not sterilized, as required, prior to distribution.
Z-1903-2011 · View FDA record ↗ - Medline Industries IncTerminatedUnknown
MEDLINE Sterile* Needle Counter, 100Ct. Double Magnet / Foam Block, reorder: DYNJNC100F
The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.
Z-1931-2018 · View FDA record ↗ - Medline Industries IncTerminatedUnknown
MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Adhesive, reorder: DYNJNC40A
The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.
Z-1932-2018 · View FDA record ↗ - Medline Industries IncTerminatedUnknown
MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Magnet, reorder: DYNJNC40F
The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.
Z-1933-2018 · View FDA record ↗ - Medline Industries IncTerminatedUnknown
MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 100 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR
The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.
Z-1934-2018 · View FDA record ↗ - Medline Industries IncTerminatedUnknown
MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 40 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR
The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.
Z-1935-2018 · View FDA record ↗ - Medline Industries IncTerminatedUnknown
MEDLINE O.R. Necessities(R) STERILE R, Needle Counter/Compte-aiguiles/Caja de agujas, Gold Standard/Standard Or/Oro y Estander, 40 Ct. Foam Block / Magnet with
The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.
Z-1936-2018 · View FDA record ↗
Registered firms
124 firms currently registered for this product code
Lynx Medical Nj
Franklin, NJ, US
Sterigenics U.s. Llc
Hayward, CA, US
Medline Industries, Lp - Northfield
Northfield, IL, US
Sterilization Services Of Virginia
RICHMOND, VA, US
Tornier Inc.
Columbia City, IN, US
Surgical Specialties Mexico S De Rl De Cv
Tijuana Baja California, MX
Barber Of Sheffield Ltd
Barnsley, South Yorkshire, GB
Key Surgical, Llc
Eden Prairie, MN, US
Hangzhou Haizhu Mim Products Co., Ltd
Hangzhou Zhejiang, CN
Celestica De Monterrey S.a. De C.v.
Apodaca Nuevo Leon, MX
Cardinal Health (kenmex Medical Specialties)
TIJUANA Baja California, MX
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Anhui Medpurest Medical Technology Co.,ltd
Anqing Anhui, CN
Hospital & Homecare Imp. & Exp. Co., Ltd
NANJING Jiangsu, CN
Midwest Sterilization Corp.
LAREDO, TX, US
Dongbang Medical Co. Ltd.
BORYEONG-SI Chungnam, KR
Cardinal Health K.k.
FUKUROI Shizuoka, JP
Sterigenics U.s., Llc
Corona, CA, US
Bausch & Lomb Incorporated
Rochester, NY, US
Dewimed Medizintechnik Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Star Sports Medicine Co., Ltd.
Beijing, CN
Aspen Surgical Products, Inc.
Caledonia, MI, US
Depuy Spine, Inc.
RAYNHAM, MA, US
Sdab Partners Llc
South Euclid, OH, US
Arthrex Logistic Center
Fort Myers, FL, US
510(k) clearances
8 clearances for this product code
- Humana USA, Inc.Dec 19, 2001
K012199 · DIGICAP
- Axya Medical, Inc.May 11, 1998
K980988 · AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS)
- Synergistic Medical Technologies, Inc.Dec 22, 1993
K932591 · ENDO-JUDGE
- Applied Medical TechnologiesOct 24, 1989
K895681 · CONTRAST BACKGROUND MATERIAL
- Sharpoint, Inc.Oct 24, 1986
K863595 · COATED SUTURE NEEDLE
- Anchor Products Co.Aug 16, 1983
K831648 · ANCHOR BRAND SURGICAL NEEDLES
- Devon Industries, Inc.Dec 14, 1981
K812444 · RADIATION STERILIZATION FOR NEEDLE CNTR
- Scanlan Intl., Inc.Sep 26, 1980
K801976 · SCANLAN STERNUM NEEDLE-SUTURE