Device recalls - difference between date entry was created in openFDA database and date manufacturer informed about recall

Question

I am using the recalls database to always be aware of the recalls for some specific vendors and products. This is the call I am doing: https://api.fda.gov/device/recall.json?search=recalling_firm:("Medtronic Inc., Cardiac Rhythm And Heart Failure (CRHF)"+OR+"Boston Scientific"+OR+"Biotronik"+OR+"St Jude Medical"+OR+"Abbott")+AND+product_code:("DSZ"+OR+"DTB"+OR+"DTD"+OR+"DTE"+OR+"DXY"+OR+"MXC"+OR+ "MXD"+OR+"PNJ"+OR+"LWP"+OR+"LWS"+OR+"LWW"+OR+"MRM"+OR+"NIK"+OR+"NKE"+OR+"NVY"+OR+"NVZ"+OR+"PCW"+OR+"QFV")&limit=1000

However, I realized for most of the recalls the event_date_initiated (Date that the firm first began notifying the public or their consignees of the recall) is 1 month earlier than the event_date_created (Date on which the recall record was created in the FDA database). Could you exolain this difference? I see the database is updated frequently (according to what you have in https://open.fda.gov/about/status/) and I am affraid I cannot use it because of this delay.

Thank you.

Answer 1

Whenever a manufacturer recalls a device, it takes time for them to prepare and submit the recall information to the FDA and then for the FDA to process, classify and publish the recall. This has nothing to do with the database refresh frequency.

If your goals are time-sensitive and you need to become aware of recalls very quickly, you might consider monitoring the manufacturers websites directly.

Alternatively, take a look at the openFDA Recall Enforcement Reports. All recalls monitored by FDA are included in the Enforcement Report once they are classified and may be listed prior to classification when FDA determines the firm’s removal or correction of a marketed product(s) meets the definition of a recall.