CLASS II ONGOING Device recall · Reported 13 May 2026 · FDA Enforcement Report

Medline Convenience Kits: Drape Pack-choice recalled

Medline Industries is recalling Medline Convenience Kits: Drape Pack-choice, distributed nationwide in the US. The recall was initiated on 7 Jan 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1) DYNJ63118A, UDI-DI: 10195327644291(each), 40195327644292(case), Lot Number: 25ABV005
Quantity recalled72 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-2122-2026
FDA event ID
98642
Recalling firm
Medline Industries, Northfield, IL
Classification
Class II
Status
Ongoing
Recall initiated
7 Jan 2026
FDA classified
7 May 2026
Reported
13 May 2026
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility

Timeline

7 Jan 2026Recall initiated by company
7 May 2026Classified by FDA+120 days
13 May 2026Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A

Where it was distributed

Worldwide - US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Which lots are affected?

1) DYNJ63118A, UDI-DI: 10195327644291(each), 40195327644292(case), Lot Number: 25ABV005

Where was it sold?

Worldwide - 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 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

35 other products · FDA event 98642

This product is part of a recall event; the main page for the event is See RES for complete list recalled by Medline Industries.

ReportedClassRecallCompanyReasonWhere
CLASS IISee RES for complete list recalled by Medline IndustriesMedline IndustriesSterilityNationwide
CLASS IIMedline Convenience Kits: WMC I D Pack-lf recalled by Medline IndustriesMedline IndustriesSterilityNationwide
CLASS IIMedline Convenience Kits: PPE KIT recalled by Medline IndustriesMedline IndustriesSterilityNationwide
CLASS IIMedline Convenience Kits: Lithotomy Pack recalled by Medline IndustriesMedline IndustriesSterilityNationwide
CLASS IIMedline Convenience Kits: Basic Nerve Block Tray W/Linen recalledMedline IndustriesSterilityNationwide
CLASS IIMedline Convenience Kits: Scc RF Pain Mgmt recalledMedline IndustriesSterilityNationwide
CLASS IIMedline Convenience Kits recalled by Medline IndustriesMedline IndustriesSterilityNationwide
CLASS IIMedline Convenience Kits: Kit Surg Onc Excision Breast recalledMedline IndustriesSterilityNationwide
CLASS IIMedline Convenience Kits: Angio Procedure Pack recalledMedline IndustriesSterilityNationwide
CLASS IIMedline Convenience Kits: KIT STC Tracheostomy recalledMedline IndustriesSterilityNationwide
CLASS IISee full list in RES, exceeds character limit GYN Laparoscopy CDS recalledMedline IndustriesSterilityNationwide
CLASS IIMedline Convenience Kits: Hysteroscopy recalled by Medline IndustriesMedline IndustriesSterilityNationwide
CLASS IIMedline Convenience Kits: PICC Line Tray recalled by Medline IndustriesMedline IndustriesSterilityNationwide
CLASS IIMedline Convenience Kits: Baptist Floyd Endo GI Kit recalledMedline IndustriesSterilityNationwide
CLASS IIMedline Convenience Kits: Arthroscopy CDS recalled by Medline IndustriesMedline IndustriesSterilityNationwide
CLASS IIMedline Convenience Kits: Angio Procedure Pack recalledMedline IndustriesSterilityNationwide
CLASS IIMedline Convenience Kits: Kit Ophthalmic Rupture Globe recalledMedline IndustriesSterilityNationwide
CLASS IIMedline Convenience Kits: Neuro Shunt- Codman recalledMedline IndustriesSterilityNationwide
CLASS IIMedline Convenience Kits: Admit KIT recalled by Medline IndustriesMedline IndustriesSterilityNationwide
CLASS IIMedline Convenience Kits: C-section Pack recalled by Medline IndustriesMedline IndustriesSterilityNationwide
CLASS IIMedline Convenience Kits: Kit Urology Sling recalledMedline IndustriesSterilityNationwide
CLASS IIMedline Convenience Kits: PICC Catheter Insertion Tray recalledMedline IndustriesSterilityNationwide
CLASS IIMedline Convenience Kits: Central Line Universal Inserti recalledMedline IndustriesSterilityNationwide
CLASS IIMedline Convenience Kits: OB KIT recalled by Medline IndustriesMedline IndustriesSterilityNationwide
CLASS IIMedline Convenience Kits: Ancillary Pack-lf recalledMedline IndustriesSterilityNationwide
CLASS IIMedline Convenience Kits: Burn Pack recalled by Medline IndustriesMedline IndustriesSterilityNationwide
CLASS IIMedline Convenience Kits: Drape Pack recalled by Medline IndustriesMedline IndustriesSterilityNationwide
CLASS IIMedline Convenience Kits: CVC PACK recalled by Medline IndustriesMedline IndustriesSterilityNationwide
CLASS IIMedline Surgical Packs: Pack,Universal,Ultragard,5/CS recalledMedline IndustriesSterilityNationwide
CLASS IIMedline Convenience Kits: Lvad Driveline Tray recalledMedline IndustriesSterilityNationwide
CLASS IIMedline Convenience Kits: Bap North Robotic Surgery Cds recalledMedline IndustriesSterilityNationwide
CLASS IIMedline Convenience Kits: Kit General Closure recalledMedline IndustriesSterilityNationwide
CLASS IISee RES for full list recalled by Medline IndustriesMedline IndustriesSterilityNationwide
CLASS IIMedline Convenience Kits: Kit Triple Lumen Insertion recalledMedline IndustriesSterilityNationwide
CLASS IIMedline Convenience Kits: Chest Tube Insertion Tray recalledMedline IndustriesSterilityNationwide

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