RegWardenFDA facility compliance records
Recall

Class II — Stryker Corporation

Recalling firmSTRYKER CORP.
Registered facilityView this company's 61 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusOngoing
ReasonPotential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type
ProductSurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and recording the number of RFID-tagged absorbent articles used during surgical procedures Product Code: 0694-002-090;
Quantity57 units
DistributionUS Nationwide distribution.
Initiated2023-07-10
Classified2023-08-25
Recall numberZ-2463-2023
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Stryker Corporation (Z-2463-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92713/

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