FDA Data Integration Notice

TERRA consumes item metadata, recall flags, and recall evaluation APIs from FDA. TERRA does NOT ingest or store FDA master data internally. (Spec §12)

Spec §12 — FDA Service Integration: TERRA polls openFDA nightly to match UDI/lot numbers against active recall database. Recall is a system-generated flag (§8.3 Item States) — not set by users.
Active Recalls §12
3
FDA-matched recalls
Affected Items §8.3
7
Items flagged across all totes
Vendors Impacted §12
2
Stryker, Medtronic
Spec §15 — Dashboard filters scope recall data by item, vendor, severity, and location. All data is tenant-scoped (§5).
Spec §12 — Each recall item is system-generated from FDA openFDA polling. Recall flag (§8.3) is appended to item state. Hospital admins can view details and export affected item lists.
FDA Class II Recall — Poly Liner 36mm
Class II
Vendor
Stryker
FDA Reference
Z-0412-2026
Date Posted
Feb 25, 2026
Affected Units
3 units
Locations
2 locations (OR-3 Tote A, OR-5 Tote B)
FDA Class I Recall — Spinal Cage System
Class I
Vendor
Medtronic
FDA Reference
Z-0389-2026
Date Posted
Feb 20, 2026
Affected Units
2 units
Locations
1 location (OR-5 Tote B)
FDA Class II Recall — Bone Cement Additive
Class II
Vendor
Stryker
FDA Reference
Z-0401-2026
Date Posted
Feb 22, 2026
Affected Units
2 units
Locations
1 location (OR-3 Tote A)
Spec §8.3 — Recall is a system-generated item state flag. It cannot be manually set by vendor reps or hospital staff. The flag is applied when an FDA recall match is detected during the nightly openFDA poll (§12).