CLASS III Device recall · Reported 13 Feb 2013 · FDA Enforcement Report
Kodak Insight Dental Film in SureSoft Packets, Size Packet Film recalled
Carestream Health is recalling Kodak Insight Dental Film in SureSoft Packets, Size Packet Film, distributed nationwide in the US. The recall was initiated on 17 Jan 2013 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0744-2013
- FDA event ID
- 64135
- Recalling firm
- Carestream Health, Rochester, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 17 Jan 2013
- FDA classified
- 4 Feb 2013
- Reported
- 13 Feb 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Imaging Equipment
Timeline
| 17 Jan 2013 | Recall initiated by company | |
| 4 Feb 2013 | Classified by FDA | +18 days |
| 13 Feb 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
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
Where it was distributed
US Nationwide Distribution including the states of California, Florida, Texas, Illinois, Indiana, Maryland, Pennsylvania and Canada.
Nationwide CaliforniaFloridaIllinoisIndianaMarylandPennsylvaniaTexas
Questions about this recall
Why was it recalled?
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
Which lots are affected?
Lot 2114596 (Exp. September 2014)
Where was it sold?
US Nationwide Distribution including the states of California, Florida, Texas, Illinois, Indiana, Maryland, Pennsylvania and Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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