CLASS II ONGOING Device recall · Reported 8 Jul 2026 · FDA Enforcement Report

Medline Convenience Kits: L&d Continuous Epidural Tray recalled

Medline Industries is recalling Medline Convenience Kits: L&d Continuous Epidural Tray, distributed nationwide in the US. The recall was initiated on 21 May 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1) PAIN1699A, UDI-DI: 10195327411107(each), 40195327411108(case), Lot Number: 25JLA719
Quantity recalled432 kits

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-2545-2026
FDA event ID
99162
Recalling firm
Medline Industries, Northfield, IL
Classification
Class II
Status
Ongoing
Recall initiated
21 May 2026
FDA classified
29 Jun 2026
Reported
8 Jul 2026
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Processing Deviation

Timeline

21 May 2026Recall initiated by company
29 Jun 2026Classified by FDA+39 days
8 Jul 2026Published in enforcement report+9 days

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

Reason for recall

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.

Product as listed by the FDA

Medline Convenience Kits: 1) L&D CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1699A

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

Which lots are affected?

1) PAIN1699A, UDI-DI: 10195327411107(each), 40195327411108(case), Lot Number: 25JLA719

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 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

14 other products · FDA event 99162

This product is part of a recall event; the main page for the event is Medline Convenience Kits: Suture Tray recalled by Medline Industries.

ReportedClassRecallCompanyReasonWhere
CLASS IIMedline Convenience Kits: Suture Tray recalled by Medline IndustriesMedline IndustriesProcessing DeviationNationwide
CLASS IIMedline Convenience Kits: Std, Intro-flex Introducer 6F recalledMedline IndustriesProcessing DeviationNationwide
CLASS IIMedline Convenience Kits: Imaging Biopsy Tray recalledMedline IndustriesProcessing DeviationNationwide
CLASS IIMedline Convenience Kits: PI CVC KIT recalled by Medline IndustriesMedline IndustriesProcessing DeviationNationwide
CLASS IIMedline Convenience Kits: Suturing SET recalled by Medline IndustriesMedline IndustriesProcessing DeviationNationwide
CLASS IIMedline Convenience Kits recalled by Medline IndustriesMedline IndustriesProcessing DeviationNationwide
CLASS IIMedline Convenience Kits: Pain Mgmt/ Pref W. Med Ndl recalledMedline IndustriesProcessing DeviationNationwide
CLASS IIMedline Convenience Kits: Arterial Access Tray W/Lidocaine recalledMedline IndustriesProcessing DeviationNationwide
CLASS IIMedline Convenience Kits: Lumbar Puncture Choice recalledMedline IndustriesProcessing DeviationNationwide
CLASS IIMedline Convenience Kits: Block Tray recalled by Medline IndustriesMedline IndustriesProcessing DeviationNationwide
CLASS IIMedline Convenience Kits: Ophthalmic Pack W/Lido recalledMedline IndustriesProcessing DeviationNationwide
CLASS IIMedline Convenience Kits: Arterial Line Kit recalledMedline IndustriesProcessing DeviationNationwide
CLASS IIMedline Convenience Kits: Mercy Medical Circumcision Tray recalledMedline IndustriesProcessing DeviationNationwide
CLASS IIMedline Convenience Kits: Multimed, Cvc Bundle recalledMedline IndustriesProcessing DeviationNationwide

More recalls from Medline Industries

All 686

Other Other Medical Devices recalls

All 13,778