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.
DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the product is 0.5% Bupivacaine
Code information
Lot Number 54239375, exp. 02/01/2022
Distribution pattern
US Nationwide distribution to the states of MS, VA, LA, and NY.
DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the product is 0.5% Bupivacaine
Code information
Lot Numbers: 54310362, exp. 01/01/2022; 54366825, exp. 01/01/2022
Distribution pattern
US Nationwide distribution to the states of MS, VA, LA, and NY.
DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the product is 0.5% Bupivacaine
Code information
Lot Numbers: 54368716, exp. 6/01/2022
Distribution pattern
US Nationwide distribution to the states of MS, VA, LA, and NY.
