CLASS II ONGOING Device recall · Reported 9 Nov 2022 · FDA Enforcement Report

Medline Lithotomy recalled by MEDLINE INDUSTRIES, LP

MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Lithotomy, distributed nationwide in the US. The recall was initiated on 30 Sep 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN (01) 4019532701228, Lot Number 22DBL482

Quantity recalled96 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-0162-2023
FDA event ID: 90946
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 30 Sep 2022
FDA classified: 1 Nov 2022
Reported: 9 Nov 2022
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Sterility
Device type: Surgical Instruments

Timeline

30 Sep 2022	Recall initiated by company
1 Nov 2022	Classified by FDA	+32 days
9 Nov 2022	Published in enforcement report	+8 days

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

Reason for recall

Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.

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 LITHOTOMY, REF DYNJ50099C. Convenience kit used in medical/surgical procedures.

Where it was distributed

US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.

Nationwide California Minnesota North Carolina New York Oklahoma Pennsylvania Tennessee Texas

Questions about this recall

Is Medline Lithotomy recalled?

Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Medline Lithotomy on 30 Sep 2022. The recall is Class II and its status is Ongoing. Recall number Z-0162-2023.

Why was it recalled?

Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.

Which lots are affected?

GTIN (01) 4019532701228, Lot Number 22DBL482

Where was it sold?

US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.

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.

More recalls from MEDLINE INDUSTRIES, LP - Northfield

All 792

Reported	Class	Recall	Company	Reason	Where
1 Oct 2025Device	CLASS I	Medline medical convenience kits labeled as recalled	MEDLINE INDUSTRIES, LP - Northfield	Device Malfunction	6 states
1 Oct 2025Device	CLASS I	Medline medical convenience kits labeled as recalled	MEDLINE INDUSTRIES, LP - Northfield	Device Malfunction	6 states
3 Sep 2025Device	CLASS I	Medline ReNewal Reprocessed St. Jude Medical Response recalled	MEDLINE INDUSTRIES, LP - Northfield	Particulate Matter	Nationwide
3 Sep 2025Device	CLASS II	The Medline General Surgery Tray is customized to meet recalled	MEDLINE INDUSTRIES, LP - Northfield	Sterility	Nationwide
3 Sep 2025Device	CLASS II	Medline Kits containing BD SureStep Foley Tray Systems recalled	MEDLINE INDUSTRIES, LP - Northfield	Labeling Errors	FL, IL

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All 3,809

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9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
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2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Sterility	Nationwide