Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 24, 2021
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.
The mirror may become detached and fall from the unit
The recall
Carestream Dental, LLC issued this moderate-severity FDA Devices recall — The mirror may become detached and fall from the unit.
- Moderate
- severity level
- 11K units
- affected scope
- Class II
- classification
- March 24, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1268-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1268-2021) was formally reported on March 24, 2021, with the manufacturer initiating the action on February 15, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Carestream Dental, LLC is listed as the recalling firm, operating out of Atlanta, GA. Federal records list the affected scope as 11400 devices.
The documented reason for this recall is: The mirror may become detached and fall from the unit Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category — 27,303 medical devices recalls on record
Where this recall sits in the database
Of 83,949 recalls in the database, 21,198 are high severity, 58,883 moderate, and 3,868 low. This recall is classified moderate severity.
Affected scope
11400 devices
Related Recalls
6
6 from same agency
Product description
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.
Reason for recall
The mirror may become detached and fall from the unit
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1268-2021 |
| Date reported | March 24, 2021 |
| Date initiated | February 15, 2021 |
| Recalling firm | Carestream Dental, LLC |
| Firm location | Atlanta, GA |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Carestream Dental, LLC. Units affected: 11400 devices.
Why was this product recalled? ▼
The mirror may become detached and fall from the unit
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 24, 2021. Severity: Moderate. Recall number: Z-1268-2021.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1268-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported March 24, 2021.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
Source: Federal recall agencies (FDA, CPSC, NHTSA) Aggregated federal recall feeds Recall data normalized across FDA, CPSC and NHTSA feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type).