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 GU, 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

Lot, batch or date codesDYNJ909398A UDI-DI 10195327338190 (EA) 40195327338191 (CS) LOTS 24GMH510 24HMG886 DYNJ908706D UDI-DI 10198459017773 (EA) 40198459017774 (CS) LOTS 24HMA783 24HMG308 24KMC651 24KMJ274 24LME931 25AME217 25BMI653 ***Updated 5/20/26 - The following lots were included in the customer letter but not in the FDA submission.*** DYNJ909398A lots 23EMF078 23HME512 23HMI269 23JMB528 23KME175 24EMC327
Quantity recalled270,311 total

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-1885-2026
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

Timeline

27 Feb 2026Recall initiated by company
17 Apr 2026Classified by FDA+49 days
29 Apr 2026Published 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 GU DAVINCI PACK - LF DYNJ909398A ROBOTIC PACK DYNJ908706D

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.

Nationwide

Questions about this recall

Why was it recalled?

Unapproved design changes to the products outside of the 510(k) clearance.

Which lots are affected?

DYNJ909398A UDI-DI 10195327338190 (EA) 40195327338191 (CS) LOTS 24GMH510 24HMG886 DYNJ908706D UDI-DI 10198459017773 (EA) 40198459017774 (CS) LOTS 24HMA783 24HMG308 24KMC651 24KMJ274 24LME931 25AME217 25BMI653 ***Updated 5/20/26 - The following lots were included in the customer letter but not in the FDA submission.*** DYNJ909398A lots 23EMF078 23HME512 23HMI269 23JMB528 23KME175 24EMC327

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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

16 other products · FDA event 98601
ReportedClassRecallCompanyReasonWhere
CLASS IIMedline Convenience Kits containing select SKUs recalledMedline IndustriesDevice MalfunctionNationwide
CLASS IIMedline Convenience Kits containing select SKUs recalledMedline IndustriesOtherNationwide
CLASS IIMedline Convenience Kits containing select SKUs recalledMedline IndustriesOtherNationwide
CLASS IIMedline Convenience Kits containing select SKUs recalledMedline IndustriesOtherNationwide
CLASS IIMedline Convenience Kits containing select SKUs recalledMedline IndustriesOtherNationwide
CLASS IIMedline Convenience Kits containing select SKUs recalledMedline IndustriesOtherNationwide
CLASS IIMedline Convenience Kits containing select SKUs recalledMedline IndustriesOtherNationwide
CLASS IIMedline Convenience Kits containing select SKUs recalledMedline IndustriesOtherNationwide
CLASS IIMedline Convenience Kits containing select SKUs recalledMedline IndustriesOtherNationwide
CLASS IIMedline Convenience Kits containing select SKUs recalledMedline IndustriesForeign MaterialNationwide
CLASS IIMedline Convenience Kits containing select SKUs recalledMedline IndustriesOtherNationwide
CLASS IIMedline Convenience Kits containing select SKUs recalledMedline IndustriesOtherNationwide
CLASS IIMedline Convenience Kits containing select SKUs recalledMedline IndustriesOtherNationwide
CLASS IIMedline Convenience Kits containing select SKUs recalledMedline IndustriesOtherNationwide
CLASS IIMedline Convenience Kits containing select SKUs recalledMedline IndustriesOtherNationwide
CLASS IIMedline Convenience Kits containing select SKUs recalledMedline IndustriesOtherNationwide

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