Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported February 12, 2014
Cornea Coat, Hydroxypropylmethylcellulose, 1.5ml Syringe, Rx Only. Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd., Stuart, FL 34994, USA. Tel: 772-219-9393.
Marketed without an Approved NDA/ANDA.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Insight Instruments, Inc. recalled Cornea Coat, Hydroxypropylmethylcellulose, 1.5ml Syringe, Rx Only. Manufactured by: Insi… - a moderate-severity action.
Cornea Coat, Hydroxypropylmethylcellulose, 1.5ml Syringe, Rx Only. Manufactured by: Insi… was recalled by Insight Instruments, Inc. in February 12, 2014. Reason: Marketed without an Approved NDA/ANDA.. Check the official notice for the remedy. Verify recall #D-1056-2014 with the FDA Drug before acting.
The recall
Insight Instruments, Inc. issued this moderate-severity FDA Drug recall-Marketed without an Approved NDA/ANDA..
- Moderate
- severity level
- Class II
- classification
- February 12, 2014
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1056-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-1056-2014) was formally reported on February 12, 2014, with the manufacturer initiating the action on April 24, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Insight Instruments, Inc. is listed as the recalling firm, operating out of Stuart, FL. Federal records list the affected scope as 316,464 kits.
The documented reason for this recall is: Marketed without an Approved NDA/ANDA. Distribution data in the federal record shows the product reached: Nationwide and Puerto Rico. 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 - 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
316,464 kits
Related Recalls
6
0 from same agency
Product description
Cornea Coat, Hydroxypropylmethylcellulose, 1.5ml Syringe, Rx Only. Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd., Stuart, FL 34994, USA. Tel: 772-219-9393.
Reason for recall
Marketed without an Approved NDA/ANDA.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-1056-2014 |
| Date reported | February 12, 2014 |
| Date initiated | April 24, 2013 |
| Recalling firm | Insight Instruments, Inc. |
| Firm location | Stuart, FL |
| Affected scope | 316,464 kits |
| Distribution | Nationwide and Puerto Rico |
Profile values are sourced directly from the official FDA Drug 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 (D-1056-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug 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 Drug 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? ▼
Cornea Coat, Hydroxypropylmethylcellulose, 1.5ml Syringe, Rx Only. Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd., Stuart, FL 34994, USA. Tel: 772-219-9393.. Recalled by Insight Instruments, Inc.. Units affected: 316,464 kits.
Why was this product recalled? ▼
Marketed without an Approved NDA/ANDA.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 12, 2014. Severity: Moderate. Recall number: D-1056-2014.
Where was the recalled product distributed? ▼
Distribution: Nationwide and Puerto Rico.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1056-2014) against your product. Visit the official FDA Drug 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 Drug, reported February 12, 2014. 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.