Counter, Sponge, Surgical
General Hospital · 21 CFR 880.2740
Recent MDR events
579 adverse event reports on file
- SituateJul 29, 2026MalfunctionCovidien1717344-2026-01006
- SITUATEJul 20, 2026InjuryCovidien1717344-2026-00970
- SITUATEJul 20, 2026InjuryCovidien1717344-2026-00971
- SITUATEJul 16, 2026MalfunctionCovidien1717344-2026-00951
- SITUATEJul 6, 2026MalfunctionCovidien1717344-2026-00914
- RF SCANNER WANDJun 30, 2026MalfunctionMedtronic Inc.MW5190056
- RF DETECTION CONSOLEJun 30, 2026MalfunctionMedtronic, Inc.MW5190057
- SITUATEJun 26, 2026MalfunctionCovidien1717344-2026-00864
- SITUATEApr 21, 2026MalfunctionCovidien1717344-2026-00565
- SITUATEApr 7, 2026InjuryCovidien1717344-2026-00536
Event type breakdown
Recalls
4 recall events for this product code
- United Orthopedic Corp.Open, ClassifiedAug 6, 2026
Brand Name: U2 Total Knee System
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
Z-2897-2026 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedApr 13, 2016
SurgiCounter scanner, part of the SurgiCount Safety-Sponge System.
The affected scanner does not correctly interact with the SC360 software. When docked pre/postoperatively, the affected SurgiCounter scanner may display an error message (code=2). Also, the SurgiCounter scanner software version number is not appropriately displayed in the SC360 application during installation.
Z-1379-2016 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedJan 15, 2015
The SurgiCounter Charging Cradle
Faulty SurgiCounter Charging Cradle can prevent the scanner from charging or downloading information after a procedure.
Z-0986-2015 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedUnknown
SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the number of RFID-
When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge to be counted without the prompt to make a case note and allowing the case to close. The software update will prevent the occurrence of this error.
Z-1452-2022 · View FDA record ↗
Registered firms
52 firms currently registered for this product code
Medline Industries, Lp - Northfield
Northfield, IL, US
J Sterling Industries Llc
Kalamazoo, MI, US
Agiliti Health - Corona
CORONA, CA, US
Zhangjiagang Blackbox Plastic Products Co., Ltd
ZhangJiaGang Jiangsu, CN
Premier Enterprises
Virudhunagar Tamil Nadu, IN
Shanghai Leyi Plastic Products Co Ltd
Shanghai, CN
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Veenak International Limited
BIRMINGHAM, GB
Mobility Source Medical Technology Co., Ltd.
Foshan Guangdong, CN
Exact Medical Manufacturing, Inc.
Changzhou Jiangsu, CN
M&s Biotics, Inc.
Houston, TX, US
Jiangsu New Pentastar Medical Products Co. Ltd.
Changzhou Jiangsu, CN
O&m Halyard, Inc.
Alpharetta, GA, US
Steris Corporation
MONTGOMERY, AL, US
Deroyal Industries, Inc.
POWELL, TN, US
Tally Surgical, Inc.
Aliso Viejo, CA, US
Gd Group Usa Company
Bartlett, IL, US
Huakang Packaging Technology Co., Ltd.
Prey Nob Preah Sihanouk, KH
Armor Plast Ltd
Bangalore Karnataka, IN
Stryker Instruments
Portage, MI, US
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
Millennium Surgical Corp
Schaumburg, IL, US
Boen Healthcare Co., Ltd.
Suzhou Jiangsu, CN
510(k) clearances
15 clearances for this product code
- Gauss Surgical, Inc.,Jun 27, 2012
K121274 · PIXEL APP
- Gauss Surgical, Inc.,Apr 9, 2012
K120473 · PIXEL APP
- Haldor Advanced Technologies, Ltd.Aug 12, 2010
K100551 · ORLOCATE SYSTEM MODEL ORL 100
- Clearcount Medical SolutionsDec 18, 2009
K093557 · SMARTWAND-DTX
- Clearcount Medical Solutions, Inc.Nov 19, 2007
K073180 · SMARTSPONGE PLUS SYSTEM
- Clearcount Medical Solutions, Inc.May 24, 2007
K071355 · SMARTSPONGE SYSTEM
- Rf Surgical Systems, Inc.Nov 2, 2006
K062642 · RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100A
- Medline Industries, Inc.Nov 2, 2006
K061316 · MEDLINE SURGICAL SPONGE SCANNER