Z-1188-2026Class II

Medline medical procedure convenience kits labeled as: 1) PACER / CATH LAB PACK-LF, Kit SKU DYNJ0972604A; 2)...

Name: Z-1188-2026 Medline medical procedure convenience kits labeled as: 1) PACER / CATH LAB PACK-LF, Kit SKU DYNJ0972604A; 2)...
Creator: Medline Industries, LP
Published: 2025-12-12
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-12-12 / Open, Classified / root cause: manufacturing process

FDA source

Medline Industries, LP began a recall of Medline medical procedure convenience kits labeled as: 1) PACER / CATH LAB PACK-LF, Kit SKU DYNJ0972604A; 2) PACEMAKER/ICD PACK, Kit SKU DYNJ33822L; 3) VENOUS... on 2025-12-12. FDA classified it as Class II and gives the reason as "Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1188-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-12
Posted: 2026-01-28
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline medical procedure convenience kits labeled as: 1) PACER / CATH LAB PACK-LF, Kit SKU DYNJ0972604A; 2) PACEMAKER/ICD PACK, Kit SKU DYNJ33822L; 3) VENOUS ACCESS PACK, Kit SKU DYNJ45640B; 4) PACEMAKER SET UP, Kit SKU DYNJ63377D; 5) PACK PACEMAKER CUSTOM,9909178, Kit SKU DYNJ65011D; 6) HEART BASIC OPEN PACK, Kit SKU DYNJ69143C; 7) SCC VEIN PACK, Kit SKU DYNJ69313; 8) CV PACK, Kit SKU DYNJ86007B.
Product code: OEZ Cardiovascular Procedure Kit
Reason for recall: Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Medline Industries issued a URGENT MEDICAL DEVICE RECALL notice to its consignees on 12/12/2025 via USPS first class mail and email. The notice explained the issue, potential risk, and requested the following: "REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-25-251-FGX2 Recall Code: 3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product." For questions, contact the Recall Department at 866-359-1704 or [email protected].
Quantity in commerce: 1,928 total
Distribution: US Nationwide distribution.
Product codes and lots: Medline Kit SKU DYNJ0972604A: UDI/DI 10889942403905 (EA) 40889942403906 (CS), Lot Number 25KMD144; Medline Kit SKU DYNJ33822L: UDI/DI 10198459385582 (EA) 40198459385583 (CS), Lot Number 25KMD419; Medline Kit SKU DYNJ45640B: UDI/DI 10193489494983 (EA) 40193489494984 (CS), Lot Number 25KMD793; Medline Kit SKU DYNJ63377D: UDI/DI 10198459514579 (EA) 40198459514570 (CS), Lot Number 25KMI988; Medline Kit SKU DYNJ65011D: UDI/DI 10198459017018 (EA) 40198459017019 (CS), Lot Number 25KMH161; Medline Kit SKU DYNJ69143C: UDI/DI 10198459478505 (EA) 40198459478506 (CS), Lot Number 25LMB211; Medline Kit SKU DYNJ69313: UDI/DI 10193489931822 (EA) 40193489931823 (CS), Lot Number 25KMJ489; Medline Kit SKU DYNJ86007B: UDI/DI 10198459260452 (EA) 40198459260453 (CS), Lot Number 25KDB551.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1188-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1186-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-28
Z-1187-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-28
Z-1188-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-28
Z-1189-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-28
Z-1190-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-28
Z-1191-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-28
Z-1192-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-28
Z-1193-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-28
Z-1194-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-28
Z-1195-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-28
Z-1196-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-28
Z-1197-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-28
Z-1198-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-28
Z-1199-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-28
Z-1200-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-28

Product code OEZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)