CLASS II ONGOING Device recall · Reported 29 Apr 2026 · FDA Enforcement Report

Medline Kits: General Laparoscopy recalled by Medline Industries

Medline Industries is recalling Medline Kits: General Laparoscopy, distributed nationwide in the US. The recall was initiated on 25 Feb 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1) CDS930027Y, UDI-DI: 10198459303128(each), 40198459303129(case), Lot Number: 25EBE671
Quantity recalled75 units

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-1840-2026
FDA event ID
98599
Recalling firm
Medline Industries, Northfield, IL
Classification
Class II
Status
Ongoing
Recall initiated
25 Feb 2026
FDA classified
17 Apr 2026
Reported
29 Apr 2026
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

25 Feb 2026Recall initiated by company
17 Apr 2026Classified by FDA+51 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

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Product as listed by the FDA

Medline Kits: 1) GENERAL LAPAROSCOPY, Model Number: CDS930027Y

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Is Medline Kits: General Laparoscopy recalled?

Yes. Medline Industries recalled Medline Kits: General Laparoscopy on 25 Feb 2026. The recall is Class II and its status is Ongoing. Recall number Z-1840-2026.

Why was it recalled?

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Which lots are affected?

1) CDS930027Y, UDI-DI: 10198459303128(each), 40198459303129(case), Lot Number: 25EBE671

Where was it sold?

US Nationwide distribution.

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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