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.
device · product 1 of 4
(Stryker) AccuPlace Straight Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.
Code information
Stryker Model: 0900-300-000; With lot numbers: 61405002, 61406007, 61408002, and 61509002. Devices distributed between 5-1-2013 and 5-31-2014 are labeled with Inrads name and product number. Devices distributed between 6-20-2014 and 12-3-15 are labeled with Strykers name and product number.
Distribution pattern
Nationwide Distribution-including the states of AZ, CA, CO, CT, FL, GA, IA, KS, MA, MI, MN, MO, NY, OH, OK, PA, TX, VA, WA, and WI.
device · product 2 of 4
(Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.
Code information
Stryker Model: 0900-400-000; With lot numbers: 61406002, 61505003. Devices distributed between 5-1-2013 and 5-31-2014 are labeled with Inrads name and product number. Devices distributed between 6-20-2014 and 12-3-15 are labeled with Strykers name and product number.
Distribution pattern
Nationwide Distribution-including the states of AZ, CA, CO, CT, FL, GA, IA, KS, MA, MI, MN, MO, NY, OH, OK, PA, TX, VA, WA, and WI.
device · product 3 of 4
50000 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.
Code information
50000 Lot numbers: 61305001, 61310001, 61312001, 61404006 Devices distributed between 5-1-2013 and 5-31-2014 are labeled with Inrads name and product number. Devices distributed between 6-20-2014 and 12-3-15 are labeled with Strykers name and product number.
Distribution pattern
Nationwide Distribution-including the states of AZ, CA, CO, CT, FL, GA, IA, KS, MA, MI, MN, MO, NY, OH, OK, PA, TX, VA, WA, and WI.
device · product 4 of 4
50001 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.
Code information
50001 Lot numbers: 61303001, 61309001, 61310001, 61404006 Devices distributed between 5-1-2013 and 5-31-2014 are labeled with Inrads name and product number. Devices distributed between 6-20-2014 and 12-3-15 are labeled with Strykers name and product number.
Distribution pattern
Nationwide Distribution-including the states of AZ, CA, CO, CT, FL, GA, IA, KS, MA, MI, MN, MO, NY, OH, OK, PA, TX, VA, WA, and WI.
