FDA Device Intelligence
HomeDevice types › LWH

Counter, Sponge, Surgical

FDA product code LWH · Class 1 · General Hospital

99
Registered devices
579
Adverse events
4
Recalls
15
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-03-19United Orthopedic Corp.Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
2022-06-15Stryker Instruments Div. of Stryker CorporationWhen 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
2016-03-21Stryker Instruments Div. of Stryker CorporationThe affected scanner does not correctly interact with the SC360 software. When docked pre/postoperatively, the affected SurgiCounter scanner may display an erro
2013-06-16Stryker Instruments Div. of Stryker CorporationFaulty SurgiCounter Charging Cradle can prevent the scanner from charging or downloading information after a procedure.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.