Z-1710-2025Class II

Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535

Name: Z-1710-2025 Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2025-03-19
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-03-19 / Open, Classified / root cause: sterility

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535 on 2025-03-19. FDA classified it as Class II and gives the reason as "It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1710-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-19
Posted: 2025-05-01
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535
Product code: LRP Tray, Surgical
Reason for recall: It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: Medline Industries issued an IMMEDIATE ACTION REQUIRED recall notice to its consignees on 03/19/2025 via email and US mail. The notice explained the issue, potential risk and requested all affected product be destroyed. Credit will be issued upon receipt of completed destruction form. Those who have transferred or further distributed the product were directed to notify those to whom the product was transferred or distributed. For questions contact 866-359-1704 or email [email protected].
Quantity in commerce: 120 units
Distribution: Worldwide distribution - US Nationwide and the countries of Panama and Canada.
Product codes and lots: UDI/DI 10653160144250 (EA) 40653160144251 (CS), Lot Numbers: 23JBU525

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1710-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1705-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-07	2025-05-01
Z-1706-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-07	2025-05-01
Z-1707-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-07	2025-05-01
Z-1708-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-07	2025-05-01
Z-1709-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-07	2025-05-01
Z-1710-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-07	2025-05-01
Z-1711-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-07	2025-05-01
Z-1712-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-07	2025-05-01
Z-1713-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-07	2025-05-01
Z-1714-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-07	2025-05-01

Product code LRP

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)