The Recall Desk
HighFDA (Devices)·Z-0176-2025·Announced 2024-10-30

Medline Medical Procedure Kits Recalled for Potential Non-Sterility Risk

Medline is recalling 88 convenience kits used in gynecological medical procedures due to potential non-sterility if the breather pouch seal is compromised. The affected lots are distributed in the US, Canada, and Panama.

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 a risk-of-harm product (sterile surgical kits) where packaging defects could result in non-sterile product use, but no illnesses or injuries have been reported. The theoretical hazard of using non-sterile surgical equipment during medical procedures meets the rubric criterion for High severity.

Plain-English summary

Medline Industries is recalling four types of medical procedure convenience kits: Abdominal Hysterectomy TEGH-LF (REF DYNJ46730), Hysteroscopy Pack (REF DYNJ49302A), Peri Gyn Pack (REF DYNJ57526A), and Hysteroscopy Tray ACS (REF DYNJ68750). A total of 88 units are affected.

The recall was initiated because certain kits packaged in breather pouch lot 323080002 may contain non-sterile product if the vendor seal is opened or unsealed. Sterility is critical for medical procedure kits used in surgical and gynecological procedures.

The affected products are distributed nationwide in the United States, as well as in Canada and Panama. Affected lot numbers are: 23LBP056 (Abdominal Hysterectomy), 24ABG706 (Hysteroscopy Pack), 23LBL679 (Peri Gyn Pack), and 24ABB984 (Hysteroscopy Tray ACS).

Healthcare facilities and consumers should verify that the kits they have are not from the affected breather pouch lot and should not use any kits from the recalled lot numbers. Contact Medline Industries with questions about affected products.

The recalled product

Product
Medline brand medical procedure convenience kits, labeled as: a) ABDOMINAL HYSTERECTOMY TEGH-LF, REF DYNJ46730; b) HYSTEROSCOPY PACK, REF DYNJ49302A; c) PERI GYN PACK, REF DYNJ57526A; d) HYSTEROSCOPY TRAY ACS, REF DYNJ68750
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Gynecological Surgical Kits
Hazard
  • non-sterile
  • packaging-defect

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 (16)

  • a) REF DYNJ46730
  • UDI/DI 40888277597199 (each)
  • 10888277597198 (case)
  • Lot Numbers: 23LBP056
  • b) REF DYNJ49302A
  • UDI/DI 40888277843395 (each)
  • 10888277843394 (case)
  • Lot Numbers: 24ABG706
  • c) REF DYNJ57526A
  • UDI/DI 40193489630931 (each)
  • 10193489630930 (case)
  • Lot Numbers: 23LBL679
  • d) REF DYNJ68750
  • UDI/DI 40193489836586 (each)
  • 10193489836585 (case)
  • Lot Numbers: 24ABB984

Distribution

Distributed nationwide across the United States.

Related recalls

Same category