CLASS II ONGOING Device recall · Reported 4 Dec 2024 · FDA Enforcement Report

Medline Shoulder Repair Pack-LF recalled by MEDLINE INDUSTRIES, LP

MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Shoulder Repair Pack-LF, distributed nationwide in the US. The recall was initiated on 15 Oct 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot number 24ABO552, exp. 9/30/2025, UDI-DI each 10195327198930, UDI-DI case 40195327198931.

Quantity recalled48 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-0534-2025
FDA event ID: 95638
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 15 Oct 2024
FDA classified: 25 Nov 2024
Reported: 4 Dec 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

15 Oct 2024	Recall initiated by company
25 Nov 2024	Classified by FDA	+41 days
4 Dec 2024	Published 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

Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.

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 Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile.

Where it was distributed

US Nationwide distribution in the states of AL, GA, MA, NJ, and PA.

Nationwide Alabama Georgia Massachusetts New Jersey Pennsylvania

Questions about this recall

Is Medline Shoulder Repair Pack-LF recalled?

Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Medline Shoulder Repair Pack-LF on 15 Oct 2024. The recall is Class II and its status is Ongoing. Recall number Z-0534-2025.

Why was it recalled?

Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.

Which lots are affected?

Lot number 24ABO552, exp. 9/30/2025, UDI-DI each 10195327198930, UDI-DI case 40195327198931.

Where was it sold?

US Nationwide distribution in the states of AL, GA, MA, NJ, and PA.

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

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1 Oct 2025Device	CLASS I	Medline medical convenience kits labeled as recalled	MEDLINE INDUSTRIES, LP - Northfield	Device Malfunction	6 states
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