Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 14, 2015
regard Item Number: 800528001, Sterile, GS0612A - Lap Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Resource Optimization & Innovation Llc recalled regard Item Number: 800528001, Sterile, GS0612A - Lap Chole Pk - surgical kit containing … - a moderate-severity action.
regard Item Number: 800528001, Sterile, GS0612A - Lap Chole Pk - surgical kit containing … was recalled by Resource Optimization & Innovation Llc in October 14, 2015. Reason: The kits contain an equipment glove component which may contain splits or holes compromising the sterility.. Check the official notice for the remedy. Verify recall #Z-0096-2016 with the FDA Devices before acting.
The recall
Resource Optimization & Innovation Llc issued this moderate-severity FDA Devices recall-The kits contain an equipment glove component which may contain splits or holes compromising the sterility..
- Moderate
- severity level
- Class II
- classification
- October 14, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0096-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0096-2016) was formally reported on October 14, 2015, with the manufacturer initiating the action on April 22, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Resource Optimization & Innovation Llc is listed as the recalling firm, operating out of Springfield, MO. Federal records list the affected scope as 924 kits.
The documented reason for this recall is: The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Distribution data in the federal record shows the product reached: Distribution was made to LA, MS, and TX.. 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
924 kits
Related Recalls
6
3 from same agency
Product description
regard Item Number: 800528001, Sterile, GS0612A - Lap Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Reason for recall
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0096-2016 |
| Date reported | October 14, 2015 |
| Date initiated | April 22, 2015 |
| Recalling firm | Resource Optimization & Innovation Llc |
| Firm location | Springfield, MO |
| Affected scope | 924 kits |
| Distribution | Distribution was made to LA, MS, and TX. |
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-0096-2016) 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? ▼
regard Item Number: 800528001, Sterile, GS0612A - Lap Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure. Recalled by Resource Optimization & Innovation Llc. Units affected: 924 kits.
Why was this product recalled? ▼
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 14, 2015. Severity: Moderate. Recall number: Z-0096-2016.
Where was the recalled product distributed? ▼
Distribution: Distribution was made to LA, MS, and TX..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0096-2016) 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 October 14, 2015. 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.