The Recall Desk
HighFDA (Devices)·Z-1616-2025·Announced 2025-04-23

Medline Sterile Convenience Kits Recalled for Weak Breather Pouch Seals

Medline Industries is recalling multiple sterile convenience kits used for obstetric and gynecological procedures due to potential weak or open seals on breather pouches, which could compromise product sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of sterile medical devices with a potential compromise to product sterility. Although no illnesses or injuries have been reported, weak or open seals on sterile procedure kits pose a meaningful risk of contamination that could result in patient harm.

Plain-English summary

Medline Industries, LP is recalling sterile convenience kits used for various procedures, including obstetric and gynecological applications. The kits are being recalled due to a potential for open or weak seals on purchased breather pouches used in packaging. These pouches are intended to maintain sterility during product storage and use.

The recalled kits include 24 different model numbers, with approximately 2,531 units affected. The products have been distributed worldwide, including throughout the United States, Canada, Mexico, Panama, and the Virgin Islands.

Customers who have received affected kits should stop using them and contact Medline Industries for guidance on replacement or disposal. Healthcare facilities should verify whether they have received products from the affected lot numbers listed in the recall notice.

The recalled product

Product
Medline Convenience kits used for various procedures: 1) UTHET TYLER OB PACK, Model Number: DYNJ68673; 2) D AND C PACK, Model Number: DYNJ66290A; 3) D & C PACK-LF, Model Number: DYNJ24159C; 4) OB PACK, Model Number: DYNJ54484A; 5) PERI GYN-LF, Model Number: DYNJS3040;
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Sterile Procedure Kit
Hazard
  • sterility-compromise
  • weak-seal

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 1) DYNJ68673
  • UDI-DI: 10193489839951(each)
  • 40193489839952(case)
  • Lot Number: 24IBG873
  • 2) DYNJ66290A
  • UDI-DI: 10193489461428(each)
  • 40193489461429(case)
  • Lot Number: 24IBG957
  • 3) DYNJ24159C
  • UDI-DI: 10198459032394(each)
  • 40198459032395(case)
  • Lot Number: 24IBL229
  • 4) DYNJ54484A
  • UDI-DI: 10193489813074(each)
  • 40193489813075(case)
  • Lot Number: 24IBS805
  • 5) DYNJS3040
  • UDI-DI: 10884389602225(each)
  • 40884389602226(case)
  • Lot Number: 24JBL655

Distribution

Distributed nationwide across the United States.

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