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

Medline Pacer Implant Pack recalled by MEDLINE INDUSTRIES, LP

Medline Industries LP - Northfield is recalling Medline Pacer Implant Pack, 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 codes(1) REF DYNJ59194A - Lot numbers 24DLA916, exp. 12/31/2025; and 24BLA030, exp. 11/30/2025; UDI-DI each 10193489573480, UDI-DI case 40193489573481; and (2) REF DYNJ904220F - Lot number 24DLA070, exp. 11/30/2024, UDI-DI each 10195327362300, UDI-DI case 40195327362301.

Quantity recalled360 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-0533-2025
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: Packaging Defects
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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

(1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ904220F, 1 kit/case, non-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

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?

(1) REF DYNJ59194A - Lot numbers 24DLA916, exp. 12/31/2025; and 24BLA030, exp. 11/30/2025; UDI-DI each 10193489573480, UDI-DI case 40193489573481; and (2) REF DYNJ904220F - Lot number 24DLA070, exp. 11/30/2024, UDI-DI each 10195327362300, UDI-DI case 40195327362301.

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 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

2 other products · FDA event 95638

Reported	Class	Recall	Company	Reason	Where
4 Dec 2024	CLASS II	Medline Open Heart CDS recalled by MEDLINE INDUSTRIES, LP	Medline Industries LP - Northfield	Packaging Defects	Nationwide
4 Dec 2024	CLASS II	Medline Shoulder Repair Pack-LF recalled by MEDLINE INDUSTRIES, LP	Medline Industries LP - Northfield	Packaging Defects	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

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