CLASS II ONGOING Device recall · Reported 22 Feb 2023 · FDA Enforcement Report

Surgical convenience kits labeled as: a) Medline General Utility recalled

MEDLINE INDUSTRIES, LP - Northfield is recalling Surgical convenience kits labeled as: a) Medline General Utility, distributed nationwide in the US. The recall was initiated on 7 Dec 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) Reorder Number DYNDA2524, GTIN 40193489361415, Lot # 22HME893 b) Reorder Number DT22705A, GTIN 40653160993224, Lot # 22HMC897 c) Reorder Number IV8635D, GTIN 40653160990261, Lot# 22HMH318 d) Reorder Number MNS12595, GTIN 40653160991015, Lot # 22HMD598

Quantity recalled630 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-1118-2023
FDA event ID: 91483
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 7 Dec 2022
FDA classified: 10 Feb 2023
Reported: 22 Feb 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

7 Dec 2022	Recall initiated by company
10 Feb 2023	Classified by FDA	+65 days
22 Feb 2023	Published 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 recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

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

Surgical convenience kits labeled as: a) MEDLINE GENERAL UTILITY, Reorder Number DYNDA2524 b) CENTURION MEDICAL PRODUCTS DIALYSIS ON/OFF BUNDLE, Reorder Number DT22705A c) CENTURION MEDICAL PRODUCTS ULTRASOUND PIV BUNDLE, Reorder Number IV8635D d) CENTURION MEDICAL PRODUCTS CUTDOWN TRAY, Reorder Number MNS12595

Where it was distributed

Nationwide

Questions about this recall

Is Surgical convenience kits labeled as: a) Medline General Utility recalled?

Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Surgical convenience kits labeled as: a) Medline General Utility on 7 Dec 2022. The recall is Class II and its status is Ongoing. Recall number Z-1118-2023.

Why was it recalled?

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

Which lots are affected?

a) Reorder Number DYNDA2524, GTIN 40193489361415, Lot # 22HME893 b) Reorder Number DT22705A, GTIN 40653160993224, Lot # 22HMC897 c) Reorder Number IV8635D, GTIN 40653160990261, Lot# 22HMH318 d) Reorder Number MNS12595, GTIN 40653160991015, Lot # 22HMD598

Where was it sold?

Nationwide

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

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
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