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.
According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. Hospira identified the particulate as human hair, embedded in and attached to a pinched area of the stopper.
Code information
CMP Kit code: CHT900 Lot numbers: 2014061950 and 2014070750 Expiration date, both lots: 2016-03
Distribution pattern
Nationwide Distribution including MA, IN, NY, GA, AL, PA, and RI.
According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. Hospira identified the particulate as human hair, embedded in and attached to a pinched area of the stopper.
Code information
CMP Kit code: DT13405 Lot numbers: 2014061250 and 2014071750 Expiration date lot 2014061250: 2016-02 Expiration date lot 2014071750: 2016-03
Distribution pattern
Nationwide Distribution including MA, IN, NY, GA, AL, PA, and RI.
device · product 3 of 4
Diagnostic Imaging Tray (General Surgery convenience kit)
According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. Hospira identified the particulate as human hair, embedded in and attached to a pinched area of the stopper.
Code information
CMP Kit code: MNS2955 Lot numbers: 2014061250 Expiration date: 2015-11
Distribution pattern
Nationwide Distribution including MA, IN, NY, GA, AL, PA, and RI.
According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. Hospira identified the particulate as human hair, embedded in and attached to a pinched area of the stopper.
Code information
CMP Kit code: OR1955 Lot numbers: 2014061850 Expiration date: 2016-03
Distribution pattern
Nationwide Distribution including MA, IN, NY, GA, AL, PA, and RI.
