Home › Device types › LWH
Counter, Sponge, Surgical
FDA product code LWH · Class 1 · General Hospital
99
Registered devices
581
Adverse events
4
Recalls
15
510(k) clearances
Devices with this code
Profemur — Microport Orthopedics Inc.HCS — DYAD MEDICAL SOURCING, LLCNA — STRYKER CORPORATIONDevon — Cardinal Health, Inc.Alleset — GRI Medical & Electronic Technology Co., Ltd.ORLocate — Steris CorporationSurgiCount — STRYKER CORPORATIONORLocate — STERIS CORPORATIONDevon — Cardinal Health, Inc.ORLocate — Steris CorporationSituate — Covidien LPN/A — STRYKER CORPORATIONSafeTCount™ — MEDICAL ACTION INDUSTRIES INC.Medical Action Industries — MEDICAL ACTION INDUSTRIES INC.Devon — Cardinal Health, Inc.Profemur — Microport Orthopedics Inc.SurgiCount — STRYKER CORPORATIONORLocate — Steris CorporationProfemur — Microport Orthopedics Inc.Profemur — Microport Orthopedics Inc.Profemur — Microport Orthopedics Inc.RF Assure — Covidien LPSituate — Covidien LPProfemur — Microport Orthopedics Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-19 | United Orthopedic Corp. | Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant. |
| 2022-06-15 | Stryker Instruments Div. of Stryker Corporation | 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 allowin |
| 2016-03-21 | Stryker Instruments Div. of Stryker Corporation | The affected scanner does not correctly interact with the SC360 software. When docked pre/postoperatively, the affected SurgiCounter scanner may display an erro |
| 2013-06-16 | Stryker Instruments Div. of Stryker Corporation | Faulty SurgiCounter Charging Cradle can prevent the scanner from charging or downloading information after a procedure. |
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