Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported May 29, 2019
LimiTorr INS9020 INS-9020 LIMITORR VOLUME LIMITING EVD 20 ML LimiTorr INS9020SP1 INS-9020SP1 LIMITORR VOLUME EVD 20ML LimiTorr INS9030 INS-9030 LIMITORR VOLUME LIMITING EVD 30 ML LimiTorr INS9030SP1 INS-9030SP1 LIMITORR VOLUME LIMITING EVD 30 ML Product Usage: The LimiTorr External CSF Drainage and Monitoring Systems provides a closed system for the CSF from the ventricles of the brain or the lumbar subarachnoid space to an external drainage bag. The LimiTorr volume limiting external CSF
The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Integra LifeSciences Corp. recalled LimiTorr INS9020 INS-9020 LIMITORR VOLUME LIMITING EVD 20 ML LimiTorr INS9020SP1 INS-902… - a critical-severity action.
LimiTorr INS9020 INS-9020 LIMITORR VOLUME LIMITING EVD 20 ML LimiTorr INS9020SP1 INS-902… was recalled by Integra LifeSciences Corp. in May 29, 2019. Reason: The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and Mo…. Check the official notice for the remedy. Verify recall #Z-1312-2019 with the FDA Devices before acting.
The recall
Integra LifeSciences Corp. issued this critical-severity FDA Devices recall-The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and Mo….
- Critical
- severity level
- 42K units
- affected scope
- Class I
- classification
- May 29, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1312-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1312-2019) was formally reported on May 29, 2019, with the manufacturer initiating the action on April 8, 2019. It is classified under Critical severity (Class I), with a current status of Terminated. Integra LifeSciences Corp. is listed as the recalling firm, operating out of Plainsboro, NJ. Federal records list the affected scope as 42102 units.
The documented reason for this recall is: The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock. Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide International distribution to Argentina, American Samoa, Australia, Canada, and Guam.. 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 high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
42102 units
Related Recalls
6
3 from same agency
Product description
LimiTorr INS9020 INS-9020 LIMITORR VOLUME LIMITING EVD 20 ML LimiTorr INS9020SP1 INS-9020SP1 LIMITORR VOLUME EVD 20ML LimiTorr INS9030 INS-9030 LIMITORR VOLUME LIMITING EVD 30 ML LimiTorr INS9030SP1 INS-9030SP1 LIMITORR VOLUME LIMITING EVD 30 ML Product Usage: The LimiTorr External CSF Drainage and Monitoring Systems provides a closed system for the CSF from the ventricles of the brain or the lumbar subarachnoid space to an external drainage bag. The LimiTorr volume limiting external CSF drainage system was designed to include a volume limiting valve mechanism which reduces the chances for excessive CSF drainage. The burette in the volume limiting external CSF drainage system contains a volume limiting valve which stops drainage when the pre-determined volume (20ml-30ml) is reached. Indications: The LimiTorr system allows for drainage and monitoring of CSF from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF in patients with infected CSF shunts, and to monitor ICP.
Reason for recall
The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1312-2019 |
| Date reported | May 29, 2019 |
| Date initiated | April 8, 2019 |
| Recalling firm | Integra LifeSciences Corp. |
| Firm location | Plainsboro, NJ |
| Affected scope | 42102 units |
| Distribution | Worldwide Distribution - US Nationwide International distribution to Argentina, American Samoa, Australia, Canada, and Guam. |
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-1312-2019) 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.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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? ▼
LimiTorr INS9020 INS-9020 LIMITORR VOLUME LIMITING EVD 20 ML LimiTorr INS9020SP1 INS-9020SP1 LIMITORR VOLUME EVD 20ML LimiTorr INS9030 INS-9030 LIMITORR VOLUME LIMITING EVD 30 ML LimiTorr INS9030SP1 INS-9030SP1 LIMITORR VOLUME LIMITING EVD 30 ML Product Usage: The LimiTorr External CSF Drainage and Monitoring Systems provides a closed system for the CSF from the ventricles of the brain or the lumbar subarachnoid space to an external drainage bag. The LimiTorr volume limiting external CSF drainage system was designed to include a volume limiting valve mechanism which reduces the chances for excessive CSF drainage. The burette in the volume limiting external CSF drainage system contains a volume limiting valve which stops drainage when the pre-determined volume (20ml-30ml) is reached. Indications: The LimiTorr system allows for drainage and monitoring of CSF from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF in patients with infected CSF shunts, and to monitor ICP.. Recalled by Integra LifeSciences Corp.. Units affected: 42102 units.
Why was this product recalled? ▼
The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 29, 2019. Severity: Critical. Recall number: Z-1312-2019.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide International distribution to Argentina, American Samoa, Australia, Canada, and Guam..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1312-2019) 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.
CPSC Moderate
Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Serious Injury from Fire and Burn Hazards
· 2026-07-02
CPSC Moderate
Daikin Comfort Technologies Manufacturing Recalls Amana Air Conditioners and Heat Pumps Due to Risk of Serious Injury f…
· 2026-06-25
CPSC Moderate
Arizer Solo III Portable Vaporizers Recalled Due to Fire and Burn Hazards; Risk of Serious Injury or Death; Imported by…
· 2026-06-18
FDA Devices Moderate
GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used i…
GE Medical Systems Information Technologies Inc · 2026-06-03
FDA Devices Critical
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) BLOCK TRAY, Medline Kit…
Medline Industries, LP · 2026-06-03
Compare this recall with Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Ser… →
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 May 29, 2019. 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.