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.
Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.
These labels are deterministic app interpretations, not FDA categories.
Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.
Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.
These labels are deterministic app interpretations, not FDA categories.
Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.
Code information
(1) REF 01N33-020 - GTIN 00884999000759, Lot #381411, Exp. 2024-09-22; (2) REF 04N62-020 - GTIN 00884999009301, Lot #382133, Exp. 2024-05-25; (3) REF 05J03-001 - GTIN 00884999009882, Lot #381111, Exp. 2024-06-17; (4) REF 05J03-004 - GTIN 00884999009912, Lot #381102, Exp. 2024-06-17; (5) REF 05J04-022 - GTIN 00884999010451, Lot #530242, Exp. 2024-03-28.
Distribution pattern
US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA.
device · product 3 of 3
Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)
Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.
These labels are deterministic app interpretations, not FDA categories.
Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.
Code information
No lot number, UDI-DI 00884999006676.
Distribution pattern
US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA.
