Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported July 11, 2012
Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains sterile instruments, drugs and other medical materials that will support the administration of spinal anesthesia for use by a surgeon, nurse or other licensed medical professional. Model number is 3403644. The intended use of this tray is to provide the surgeon, nurse or other licensed medical professional, a kit of sterile instruments, drugs and other medical materials that will sup
Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Integra LifeSciences Corp. d.b.a. Integra Pain Management recalled Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 8411… - a low-severity action.
Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 8411… was recalled by Integra LifeSciences Corp. d.b.a. Integra Pain Management in July 11, 2012. Reason: Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently ship…. Check the official notice for the remedy. Verify recall #Z-1943-2012 with the FDA Devices before acting.
The recall
Integra LifeSciences Corp. d.b.a. Integra Pain Management issued this low-severity FDA Devices recall-Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently ship….
- Low
- severity level
- Class III
- classification
- July 11, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1943-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1943-2012) was formally reported on July 11, 2012, with the manufacturer initiating the action on June 7, 2012. It is classified under Low severity (Class III), with a current status of Terminated. Integra LifeSciences Corp. d.b.a. Integra Pain Management is listed as the recalling firm, operating out of Salt Lake City, UT. Federal records list the affected scope as 4 cases x 10 units per case.
The documented reason for this recall is: Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components. Distribution data in the federal record shows the product reached: Nationwide Distribution including MA. 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
4 cases x 10 units per case
Related Recalls
6
3 from same agency
Product description
Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains sterile instruments, drugs and other medical materials that will support the administration of spinal anesthesia for use by a surgeon, nurse or other licensed medical professional. Model number is 3403644. The intended use of this tray is to provide the surgeon, nurse or other licensed medical professional, a kit of sterile instruments, drugs and other medical materials that will support the administration of anesthesia, be it local, spinal or general administration.
Reason for recall
Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-1943-2012 |
| Date reported | July 11, 2012 |
| Date initiated | June 7, 2012 |
| Recalling firm | Integra LifeSciences Corp. d.b.a. Integra Pain Management |
| Firm location | Salt Lake City, UT |
| Affected scope | 4 cases x 10 units per case |
| Distribution | Nationwide Distribution including MA |
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-1943-2012) 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? ▼
Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains sterile instruments, drugs and other medical materials that will support the administration of spinal anesthesia for use by a surgeon, nurse or other licensed medical professional. Model number is 3403644. The intended use of this tray is to provide the surgeon, nurse or other licensed medical professional, a kit of sterile instruments, drugs and other medical materials that will support the administration of anesthesia, be it local, spinal or general administration.. Recalled by Integra LifeSciences Corp. d.b.a. Integra Pain Management. Units affected: 4 cases x 10 units per case.
Why was this product recalled? ▼
Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 11, 2012. Severity: Low. Recall number: Z-1943-2012.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution including MA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1943-2012) 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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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 July 11, 2012. 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.