openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a short delay in procedure.
These labels are deterministic app interpretations, not FDA categories.
Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a short delay in procedure.
Code information
UDI-DI 4046955075546 Firm did not identify affected lots or expiration date. Affected product was distributed between November 23, 2022 and October 13, 2023.
Distribution pattern
US Nationwide distribution in the states of CA, CO, FL, ID, KY, MD, MO, MT, NV, NY, OR, PA, RI, TN, TX, VA.
Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a short delay in procedure.
These labels are deterministic app interpretations, not FDA categories.
Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a short delay in procedure.
Code information
UDI-DI 4046955075379 Firm did not identify affected lots or expiration date. Affected product was distributed between November 23, 2022 and October 6, 2023.
Distribution pattern
US Nationwide distribution in the states of CA, CO, FL, ID, KY, MD, MO, MT, NV, NY, OR, PA, RI, TN, TX, VA.
