Z-3208-2026Class II

Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYNJ40734F

Name: Z-3208-2026 Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYNJ40734F
Creator: Medline Industries, LP
Published: 2026-07-31
License: https://open.fda.gov/license/

Medline Industries, LP / initiated 2026-07-31 / Open, Classified

FDA source

Recall record

Recall number: Z-3208-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-31
Posted: 2026-09-16
Recalling firm: Medline Industries, LP
Product: Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYNJ40734F
Product code: FDE Laparoscopy Kit
Reason for recall: Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.
FDA root cause: Under Investigation by firm
Action: Firm began notifying customers on July 31, 2026 via email and first-class mail. Customers were instructed to discard any affected sterile convenience kits.
Quantity in commerce: 459
Distribution: US Nationwide distribution in states of Arkansas, Florida, North Carolina, Maryland, and Texas.
Product codes and lots: DYNJ58421A UDI-DI 10193489970487 Lot 25HBQ049 DYNJ40734F UDI-DI 10198459162084 Lots 25GBO299 25IBS607

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3208-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3207-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16
Z-3208-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16
Z-3209-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16
Z-3210-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16

Product code FDE

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 2026-09-23. View this recall on fda.gov (opens on fda.gov)