Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported March 12, 2025
DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C7100NS Tubing, Suction, Connector Indicated use - Fluid Movement
Due to the inner diameter of the suction tubing connector being smaller than the suction canister lid port connection. This size difference, combined with the durometer of the pla…
DeRoyal Industries Inc recalled DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suctio… - a moderate-severity action.
DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suctio… was recalled by DeRoyal Industries Inc in March 12, 2025. Reason: Due to the inner diameter of the suction tubing connector being smaller than the suction canister lid port co…. Check the official notice for the remedy. Verify recall #Z-1291-2025 with the FDA Devices before acting.
The recall
DeRoyal Industries Inc issued this moderate-severity FDA Devices recall-Due to the inner diameter of the suction tubing connector being smaller than the suction canister lid port co….
- Moderate
- severity level
- Class II
- classification
- March 12, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1291-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1291-2025) was formally reported on March 12, 2025, with the manufacturer initiating the action on January 31, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. DeRoyal Industries Inc is listed as the recalling firm, operating out of Powell, TN. Federal records list the affected scope as 714 cases.
The documented reason for this recall is: Due to the inner diameter of the suction tubing connector being smaller than the suction canister lid port connection. This size difference, combined with the durometer of the plastic material, makes the assembly to a s… Distribution data in the federal record shows the product reached: U.S.: IL, MN, NC, PA, and VA O.U.S.: N/A. 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
714 cases
Related Recalls
6
3 from same agency
Product description
DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C7100NS Tubing, Suction, Connector Indicated use - Fluid Movement
Reason for recall
Due to the inner diameter of the suction tubing connector being smaller than the suction canister lid port connection. This size difference, combined with the durometer of the plastic material, makes the assembly to a suction canister lid port difficult. This could result in inadequate suction and cause a delay in patient care.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1291-2025 |
| Date reported | March 12, 2025 |
| Date initiated | January 31, 2025 |
| Recalling firm | DeRoyal Industries Inc |
| Firm location | Powell, TN |
| Affected scope | 714 cases |
| Distribution | U.S.: IL, MN, NC, PA, and VA O.U.S.: N/A |
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-1291-2025) 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? ▼
DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C7100NS Tubing, Suction, Connector Indicated use - Fluid Movement. Recalled by DeRoyal Industries Inc. Units affected: 714 cases.
Why was this product recalled? ▼
Due to the inner diameter of the suction tubing connector being smaller than the suction canister lid port connection. This size difference, combined with the durometer of the plastic material, makes the assembly to a suction canister lid port difficult. This could result in inadequate suction and cause a delay in patient care.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 12, 2025. Severity: Moderate. Recall number: Z-1291-2025.
Where was the recalled product distributed? ▼
Distribution: U.S.: IL, MN, NC, PA, and VA O.U.S.: N/A.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1291-2025) 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.
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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 March 12, 2025. 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.