Z-1268-2021Class II

Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 -

Name: Z-1268-2021 Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 -
Creator: Carestream Dental, Llc
Published: 2021-02-15
License: https://open.fda.gov/license/

Carestream Dental LLC / initiated 2021-02-15 / Terminated / root cause: design

FDA source

CARESTREAM DENTAL, LLC began a recall of Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Product Usage: used to record the topographic characteristics of teeth or dental... on 2021-02-15. FDA classified it as Class II and gives the reason as "The mirror may become detached and fall from the unit". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1268-2021
Classification: Class II
Status: Terminated
Initiated: 2021-02-15
Posted: 2021-03-17
Terminated: 2023-01-14
Recalling firm: Carestream Dental LLC
Product: Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Product Usage: used to record the topographic characteristics of teeth or dental impressions in three dimensions.
Product code: NOF System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
Reason for recall: The mirror may become detached and fall from the unit
Root cause tag: design
FDA root cause: Device Design
Action: The firm initiated the recall by letter on 02/2/2021. The letter explained the problem, requested the consignee cease use of the product and return all affected product.
Quantity in commerce: 11400 devices
Distribution: Worldwide distribution - US Nationwide distribution in the states of WA, MD, WV, NE, SC, NJ, FL, OH, CA, OR, LA, MO, NY, MI, MA, ID, TN, GA, MN, NC, PA, AZ, OK, IN and the country of Canada.
Product codes and lots: All lot numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1268-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1268-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-24	2021-03-17

Product code NOF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)