CLASS II ONGOING Device recall · Reported 29 Apr 2026 · FDA Enforcement Report
Medline Convenience Kits containing select SKUs recalled
Medline Industries is recalling Medline Convenience Kits containing select SKUs of Polycarbonate Colored Syringes, distributed nationwide in the US. The recall was initiated on 27 Feb 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1888-2026
- FDA event ID
- 98601
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Feb 2026
- FDA classified
- 17 Apr 2026
- Reported
- 29 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 27 Feb 2026 | Recall initiated by company | |
| 17 Apr 2026 | Classified by FDA | +49 days |
| 29 Apr 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Unapproved design changes to the products outside of the 510(k) clearance.
Product as listed by the FDA
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTHROSCOPY PACK DYNJ45173D
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Questions about this recall
Is Medline Convenience Kits containing select SKUs of Polycarbonate Colored Syringes recalled?
Yes. Medline Industries recalled Medline Convenience Kits containing select SKUs of Polycarbonate Colored Syringes on 27 Feb 2026. The recall is Class II and its status is Ongoing. Recall number Z-1888-2026.
Why was it recalled?
Unapproved design changes to the products outside of the 510(k) clearance.
Which lots are affected?
DYNJ45173D UDI-DI 10889942485222 (EA) 40889942485223 (CS) LOT 24BBB811
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
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