Data Foundry

Medical device recalls 2026

WB Impression Post Closed Tray incl — Class III medical device recall Z-1337-2026

Ongoing recall by Straumann USA LLC, reported 2026-02-18, distributed nationwide. The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of

Recall numberZ-1337-2026
Product typeMedical device
ClassificationClass III
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmStraumann USA LLC, Andover, MA, United States
Recall initiated2026-01-06
Classified2026-02-09
Reported by FDA2026-02-18
DistributedNationwide (US)
Quantity561 units
UPC / GTIN / UDI-DI07630031741110
Lot numbersVWPX4, VWPX6

Product

WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM

Reason for recall

The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1337-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.