Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 25, 2013
Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Integra kits which contain a BD LOR syringe are intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, local or spinal anesthetics. The BD LOR syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement is in the epidural space by us
Integra LifeSciences Corporation is recalling certain lots of Integra Kits for Epidural Anesthesia Administration as a result of a Product Advisory Notice from BD Medical for the …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Integra LifeSciences Corp. d.b.a. Integra Pain Management recalled Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx … - a moderate-severity action.
Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx … was recalled by Integra LifeSciences Corp. d.b.a. Integra Pain Management in December 25, 2013. Reason: Integra LifeSciences Corporation is recalling certain lots of Integra Kits for Epidural Anesthesia Administra…. Check the official notice for the remedy. Verify recall #Z-0533-2014 with the FDA Devices before acting.
The recall
Integra LifeSciences Corp. d.b.a. Integra Pain Management issued this moderate-severity FDA Devices recall-Integra LifeSciences Corporation is recalling certain lots of Integra Kits for Epidural Anesthesia Administra….
- Moderate
- severity level
- 359K units
- affected scope
- Class II
- classification
- December 25, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0533-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0533-2014) was formally reported on December 25, 2013, with the manufacturer initiating the action on October 28, 2013. It is classified under Moderate severity (Class II), 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 359,250, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: Integra LifeSciences Corporation is recalling certain lots of Integra Kits for Epidural Anesthesia Administration as a result of a Product Advisory Notice from BD Medical for the LOR syringes indicating the plunger of t… Distribution data in the federal record shows the product reached: USA Nationwide Distribution and one foreign consignee in Mursalat.. 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 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
359,250
Related Recalls
6
3 from same agency
Product description
Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Integra kits which contain a BD LOR syringe are intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, local or spinal anesthetics. The BD LOR syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement is in the epidural space by use of the Loss of Resistance Technique as detailed in medical textbooks and medical journal articles. The LOR Syringe is not intended for injection or aspiration.
Reason for recall
Integra LifeSciences Corporation is recalling certain lots of Integra Kits for Epidural Anesthesia Administration as a result of a Product Advisory Notice from BD Medical for the LOR syringes indicating the plunger of the syringe may stall or stick when travelling within the syringe.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0533-2014 |
| Date reported | December 25, 2013 |
| Date initiated | October 28, 2013 |
| Recalling firm | Integra LifeSciences Corp. d.b.a. Integra Pain Management |
| Firm location | Salt Lake City, UT |
| Affected scope | 359,250 |
| Distribution | USA Nationwide Distribution and one foreign consignee in Mursalat. |
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-0533-2014) 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? ▼
Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Integra kits which contain a BD LOR syringe are intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, local or spinal anesthetics. The BD LOR syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement is in the epidural space by use of the Loss of Resistance Technique as detailed in medical textbooks and medical journal articles. The LOR Syringe is not intended for injection or aspiration.. Recalled by Integra LifeSciences Corp. d.b.a. Integra Pain Management. Units affected: 359,250.
Why was this product recalled? ▼
Integra LifeSciences Corporation is recalling certain lots of Integra Kits for Epidural Anesthesia Administration as a result of a Product Advisory Notice from BD Medical for the LOR syringes indicating the plunger of the syringe may stall or stick when travelling within the syringe.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 25, 2013. Severity: Moderate. Recall number: Z-0533-2014.
Where was the recalled product distributed? ▼
Distribution: USA Nationwide Distribution and one foreign consignee in Mursalat..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0533-2014) 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 December 25, 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.