KODAK INSIGHT DENTAL FILM in SureSoft Packets — Class III medical device recall Z-0744-2013
Terminated recall by Carestream Health, Inc., reported 2013-02-13, distributed nationwide. Missing symbols and manufacturing information on the clear carton label. The expiration dating symbol is missi
| Recall number | Z-0744-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carestream Health, Inc., Rochester, NY, United States |
| Recall initiated | 2013-01-17 |
| Classified | 2013-02-04 |
| Reported by FDA | 2013-02-13 |
| Terminated | 2016-05-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Reason classes | labeling |
| Lot numbers | 2114596 |
| Model numbers | 8118226, IP21S |
| Expiration dates | 2014-09-20 |
Product
KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number IP21S, REF/Catalog Number 8118226 --- COMMON/USUAL NAME: Dental Intraoral Radiographic Film -- 20 cartons of 80 packets. Product Usage: Dental intraoral radiography
Reason for recall
Missing symbols and manufacturing information on the clear carton label. The expiration dating symbol is missing but the expiration date is not missing. The Lot symbol is missing but the lot number is not missing. The Manufacturer symbol, name and address including country of origin are missing. All of the remaining symbols and information are on the case label. Missing information is only a
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0744-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.