CLASS II ONGOING Device recall · Reported 26 Nov 2025 · FDA Enforcement Report

Medline convenience kits labeled as: Cath Lab Pacemaker Pack recalled

Medline Industries is recalling Medline convenience kits labeled as: Cath Lab Pacemaker Pack, distributed nationwide in the US. The recall was initiated on 30 Sep 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI 10195327333256 (each), 40195327333257 (case), Lot Numbers: 23KLA460
Quantity recalled12 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-0512-2026
FDA event ID
97846
Recalling firm
Medline Industries, Northfield, IL
Classification
Class II
Status
Ongoing
Recall initiated
30 Sep 2025
FDA classified
14 Nov 2025
Reported
26 Nov 2025
Type
Voluntary: Firm initiated
Customers notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category
Other Reasons

Timeline

30 Sep 2025Recall initiated by company
14 Nov 2025Classified by FDA+45 days
26 Nov 2025Published 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

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

Product as listed by the FDA

MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818A

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

Which lots are affected?

UDI/DI 10195327333256 (each), 40195327333257 (case), Lot Numbers: 23KLA460

Where was it sold?

US Nationwide distribution.

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

18 other products · FDA event 97846

This product is part of a recall event; the main page for the event is Medline convenience kits labeled as: Ach Plastics Breast-lf recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IIMedline convenience kits labeled as: Ach Plastics Breast-lf recalledMedline IndustriesE. coliNationwide
CLASS IIMedline convenience kits labeled as: Circumcision Pack recalledMedline IndustriesOtherNationwide
CLASS IIMedline convenience kits labeled as: Minor Eye Tray #81 recalledMedline IndustriesOtherNationwide
CLASS IIMedline convenience kits labeled as: Central Line Pack recalledMedline IndustriesOtherNationwide
CLASS IIMedline convenience kits labeled as: Gp-leep Pack-lf recalledMedline IndustriesOtherNationwide
CLASS IIMedline convenience kits labeled as: Gyn Laparoscopy Cds #34-RF recalledMedline IndustriesOtherNationwide
CLASS IIMedline convenience kits labeled as: Major Vaginal Harper Pack-lf recalledMedline IndustriesOtherNationwide
CLASS IIMedline convenience kits labeled as: C-section OR 30 Cds recalledMedline IndustriesOtherNationwide
CLASS IIMedline convenience kits labeled as Local Basic recalledMedline IndustriesOtherNationwide
CLASS IIMedline convenience kits labeled as: Major Laparotomy Cds recalledMedline IndustriesOtherNationwide
CLASS IIMedline convenience kits labeled as: General Aaa #11-RF recalledMedline IndustriesOtherNationwide
CLASS IIMedline convenience kits labeled as: General Laparoscopy recalledMedline IndustriesOtherNationwide
CLASS IIMedline convenience kits labeled as: Minor Single Basin Pack recalledMedline IndustriesOtherNationwide
CLASS IIMedline convenience kits labeled as: Breast Biopsy Pack-lf recalledMedline IndustriesE. coliNationwide
CLASS IIMedline convenience kits labeled as: Port Insertion Pack recalledMedline IndustriesOtherNationwide
CLASS IIMedline convenience kits labeled as: Gyn Laparotomy Harper Pack-lf recalledMedline IndustriesOtherNationwide
CLASS IIMedline convenience kits labeled as: Head And Neck recalledMedline IndustriesOtherNationwide
CLASS IIMedline convenience kits labeled as: Basic Neuro Pack recalledMedline IndustriesOtherNationwide

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