CLASS II ONGOING Device recall · Reported 8 Feb 2023 · FDA Enforcement Report

Non-sterile procedural trays labeled as Major/Minor recalled

Medline Industries LP - Northfield is recalling Non-sterile procedural trays labeled as Major/Minor, distributed nationwide in the US. The recall was initiated on 17 Nov 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem Number: DYNJ900416M, UDI/GTIN Case: 40195327031672, UDI/GTIN Each: 10195327031671, Lot Number: 22IBQ980

Quantity recalled160 cases (480 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-1032-2023
FDA event ID: 91387
Recalling firm: Medline Industries LP - Northfield, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 17 Nov 2022
FDA classified: 27 Jan 2023
Reported: 8 Feb 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

17 Nov 2022	Recall initiated by company
27 Jan 2023	Classified by FDA	+71 days
8 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

Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.

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

Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case

Where it was distributed

US Nationwide distribution in the states of AR, MD, WA, WI.

Nationwide Arkansas Maryland Washington Wisconsin

Questions about this recall

Why was it recalled?

Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.

Which lots are affected?

Item Number: DYNJ900416M, UDI/GTIN Case: 40195327031672, UDI/GTIN Each: 10195327031671, Lot Number: 22IBQ980

Where was it sold?

US Nationwide distribution in the states of AR, MD, WA, WI.

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

6 other products · FDA event 91387

Reported	Class	Recall	Company	Reason	Where
8 Feb 2023	CLASS II	Non-sterile procedural trays labeled as Ortho Trauma recalled	Medline Industries LP - Northfield	Sterility	Nationwide
8 Feb 2023	CLASS II	Non-sterile procedural trays labeled as Crani recalled	Medline Industries LP - Northfield	Sterility	Nationwide
8 Feb 2023	CLASS II	Non-sterile procedural trays labeled as Total Knee Kit recalled	Medline Industries LP - Northfield	Sterility	Nationwide
8 Feb 2023	CLASS II	Non-sterile procedural trays labeled as Theda Clark Total Knee Cds recalled	Medline Industries LP - Northfield	Sterility	Nationwide
8 Feb 2023	CLASS II	Non-sterile procedural trays labeled as Laparotomy CDS recalled	Medline Industries LP - Northfield	Sterility	Nationwide
8 Feb 2023	CLASS II	Non-sterile procedural trays labeled as Laparoscopic recalled	Medline Industries LP - Northfield	Sterility	Nationwide

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 Other Medical Devices recalls

All 13,778

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16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide