Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported February 13, 2013
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
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 missin…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Carestream Health, Inc. recalled KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number I… - a low-severity action.
KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number I… was recalled by Carestream Health, Inc. in February 13, 2013. Reason: Missing symbols and manufacturing information on the clear carton label. The expiration dating symbol is mis…. Check the official notice for the remedy. Verify recall #Z-0744-2013 with the FDA Devices before acting.
The recall
Carestream Health, Inc. issued this low-severity FDA Devices recall-Missing symbols and manufacturing information on the clear carton label. The expiration dating symbol is mis….
- Low
- severity level
- Class III
- classification
- February 13, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0744-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0744-2013) was formally reported on February 13, 2013, with the manufacturer initiating the action on January 17, 2013. It is classified under Low severity (Class III), with a current status of Terminated. Carestream Health, Inc. is listed as the recalling firm, operating out of Rochester, NY. Federal records list the affected scope as 101 cartons: Domestic - 95 cartons; Foreign - 6 cartons.
The documented reason for this recall is: 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. Th… Distribution data in the federal record shows the product reached: US Nationwide Distribution including the states of California, Florida, Texas, Illinois, Indiana, Maryland, Pennsylvania and 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
101 cartons: Domestic - 95 cartons; Foreign - 6 cartons
Related Recalls
6
3 from same agency
Product description
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0744-2013 |
| Date reported | February 13, 2013 |
| Date initiated | January 17, 2013 |
| Recalling firm | Carestream Health, Inc. |
| Firm location | Rochester, NY |
| Affected scope | 101 cartons: Domestic - 95 cartons; Foreign - 6 cartons |
| Distribution | US Nationwide Distribution including the states of California, Florida, Texas, Illinois, Indiana, Maryland, Pennsylvania and Canada. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0744-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Carestream Health, Inc.. Units affected: 101 cartons: Domestic - 95 cartons; Foreign - 6 cartons.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on February 13, 2013. Severity: Low. Recall number: Z-0744-2013.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution including the states of California, Florida, Texas, Illinois, Indiana, Maryland, Pennsylvania and Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0744-2013) 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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 13, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.