Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported November 20, 2024
Clean Catch Kit, SKU DYKM1833A; Component No. 503581
Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hos…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medline Industries, LP - Northfield recalled Clean Catch Kit, SKU DYKM1833A; Component No. 503581 - a moderate-severity action.
Clean Catch Kit, SKU DYKM1833A; Component No. 503581 was recalled by Medline Industries, LP - Northfield in November 20, 2024. Reason: Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-te…. Check the official notice for the remedy. Verify recall #Z-0354-2025 with the FDA Devices before acting.
The recall
Medline Industries, LP - Northfield issued this moderate-severity FDA Devices recall-Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-te….
- Moderate
- severity level
- Class II
- classification
- November 20, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0354-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0354-2025) was formally reported on November 20, 2024, with the manufacturer initiating the action on October 23, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Medline Industries, LP - Northfield is listed as the recalling firm, operating out of Northfield, IL. Federal records list the affected scope as 626,305 Total Kits (US only).
The documented reason for this recall is: Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization. Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA.. 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
626,305 Total Kits (US only)
Related Recalls
6
3 from same agency
Product description
Clean Catch Kit, SKU DYKM1833A; Component No. 503581
Reason for recall
Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0354-2025 |
| Date reported | November 20, 2024 |
| Date initiated | October 23, 2024 |
| Recalling firm | Medline Industries, LP - Northfield |
| Firm location | Northfield, IL |
| Affected scope | 626,305 Total Kits (US only) |
| Distribution | US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA. |
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-0354-2025) 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? ▼
Clean Catch Kit, SKU DYKM1833A; Component No. 503581. Recalled by Medline Industries, LP - Northfield. Units affected: 626,305 Total Kits (US only).
Why was this product recalled? ▼
Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 20, 2024. Severity: Moderate. Recall number: Z-0354-2025.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0354-2025) 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.
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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 November 20, 2024. 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.