Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported May 20, 2026
Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508; 2. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60160075; 3. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ04636N; 4. CATH LAB TRAY, Medline Kit Number/SKU DYNJ24250G; 5. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333D; 6. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333F; 7. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779G;
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medline Industries, LP recalled Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. MTS,RT,HAN… - a critical-severity action.
Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. MTS,RT,HAN… was recalled by Medline Industries, LP in May 20, 2026. Reason: Medline has identified the presence of particulate within the fluid path of the Manifolds.. Check the official notice for the remedy. Verify recall #Z-2147-2026 with the FDA Devices before acting.
The recall
Medline Industries, LP issued this critical-severity FDA Devices recall-Medline has identified the presence of particulate within the fluid path of the Manifolds..
- Critical
- severity level
- Class I
- classification
- May 20, 2026
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2147-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2147-2026) was formally reported on May 20, 2026, with the manufacturer initiating the action on March 24, 2026. It is classified under Critical severity (Class I), with a current status of Ongoing. Medline Industries, LP is listed as the recalling firm, operating out of Northfield, IL. Federal records list the affected scope as 21119 kits.
The documented reason for this recall is: Medline has identified the presence of particulate within the fluid path of the Manifolds. Distribution data in the federal record shows the product reached: US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.. 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 and 2 from Medline Industries, LP - 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
21119 kits
Related Recalls
6
3 from same agency
Product description
Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508; 2. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60160075; 3. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ04636N; 4. CATH LAB TRAY, Medline Kit Number/SKU DYNJ24250G; 5. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333D; 6. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333F; 7. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779G; 8. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779I; 9. CLOT RETRIEVAL PACK, Medline Kit Number/SKU DYNJ56140C; 10. TAVR PACK NO SYR, Medline Kit Number/SKU DYNJ62310C; 11. TAVR PACK, Medline Kit Number/SKU DYNJ62310D; 12. TAVR PACK, Medline Kit Number/SKU DYNJ62310F; 13. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911; 14. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911A; 15. CATH PACK, Medline Kit Number/SKU DYNJT6544; 16. LHK, Medline Kit Number/SKU NAM0015; 17. SLU LHK, Medline Kit Number/SKU SAMPC0706.
Reason for recall
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-2147-2026 |
| Date reported | May 20, 2026 |
| Date initiated | March 24, 2026 |
| Recalling firm | Medline Industries, LP |
| Firm location | Northfield, IL |
| Affected scope | 21119 kits |
| Distribution | US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK. |
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-2147-2026) 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? ▼
Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508; 2. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60160075; 3. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ04636N; 4. CATH LAB TRAY, Medline Kit Number/SKU DYNJ24250G; 5. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333D; 6. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333F; 7. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779G; 8. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779I; 9. CLOT RETRIEVAL PACK, Medline Kit Number/SKU DYNJ56140C; 10. TAVR PACK NO SYR, Medline Kit Number/SKU DYNJ62310C; 11. TAVR PACK, Medline Kit Number/SKU DYNJ62310D; 12. TAVR PACK, Medline Kit Number/SKU DYNJ62310F; 13. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911; 14. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911A; 15. CATH PACK, Medline Kit Number/SKU DYNJT6544; 16. LHK, Medline Kit Number/SKU NAM0015; 17. SLU LHK, Medline Kit Number/SKU SAMPC0706.. Recalled by Medline Industries, LP. Units affected: 21119 kits.
Why was this product recalled? ▼
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 20, 2026. Severity: Critical. Recall number: Z-2147-2026.
Where was the recalled product distributed? ▼
Distribution: US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2147-2026) 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
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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 May 20, 2026. 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.