Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 5, 2012
Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The intended use of these devices is to protect both patient and healthcare worker from transfer of microorganisms, body fluids and particulate matter.
The firm initiated the recall due to a labeling error. The boxes labeled as Pinnacle Cure Sleeve 4511, which fits 11mm light guides, actually contain Pinnacle Cure Sleeves that fi…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Metrex Research, LLC. recalled Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The intende… - a moderate-severity action.
Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The intende… was recalled by Metrex Research, LLC. in December 5, 2012. Reason: The firm initiated the recall due to a labeling error. The boxes labeled as Pinnacle Cure Sleeve 4511, which …. Check the official notice for the remedy. Verify recall #Z-0444-2013 with the FDA Devices before acting.
The recall
Metrex Research, LLC. issued this moderate-severity FDA Devices recall-The firm initiated the recall due to a labeling error. The boxes labeled as Pinnacle Cure Sleeve 4511, which ….
- Moderate
- severity level
- 3K units
- affected scope
- Class II
- classification
- December 5, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0444-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0444-2013) was formally reported on December 5, 2012, with the manufacturer initiating the action on September 20, 2011. It is classified under Moderate severity (Class II), with a current status of Terminated. Metrex Research, LLC. is listed as the recalling firm, operating out of Romulus, MI. Federal records list the affected scope as 3,348 units.
The documented reason for this recall is: The firm initiated the recall due to a labeling error. The boxes labeled as Pinnacle Cure Sleeve 4511, which fits 11mm light guides, actually contain Pinnacle Cure Sleeves that fit 7mm or 8mm light guides (part number 4… Distribution data in the federal record shows the product reached: Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, and Europe.. 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
3,348 units
Related Recalls
6
3 from same agency
Product description
Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The intended use of these devices is to protect both patient and healthcare worker from transfer of microorganisms, body fluids and particulate matter.
Reason for recall
The firm initiated the recall due to a labeling error. The boxes labeled as Pinnacle Cure Sleeve 4511, which fits 11mm light guides, actually contain Pinnacle Cure Sleeves that fit 7mm or 8mm light guides (part number 4500).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0444-2013 |
| Date reported | December 5, 2012 |
| Date initiated | September 20, 2011 |
| Recalling firm | Metrex Research, LLC. |
| Firm location | Romulus, MI |
| Affected scope | 3,348 units |
| Distribution | Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, and Europe. |
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-0444-2013) 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? ▼
Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The intended use of these devices is to protect both patient and healthcare worker from transfer of microorganisms, body fluids and particulate matter.. Recalled by Metrex Research, LLC.. Units affected: 3,348 units.
Why was this product recalled? ▼
The firm initiated the recall due to a labeling error. The boxes labeled as Pinnacle Cure Sleeve 4511, which fits 11mm light guides, actually contain Pinnacle Cure Sleeves that fit 7mm or 8mm light guides (part number 4500).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 5, 2012. Severity: Moderate. Recall number: Z-0444-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, and Europe..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0444-2013) 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.
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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 5, 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.