The Recall Desk
ModerateFDA (Devices)·Z-1597-2025·Announced 2025-04-23

Medline Convenience Kits Recalled for Potentially Open Breather Pouches

Medline Industries is recalling select sterile convenience kits because purchased breather pouches used for packaging may have open or weak seals, potentially compromising the sterility of the kits.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a Class II FDA recall involving a defect (open/weak seals) that could compromise sterility of medical devices. The hazard is precautionary—no illnesses or injuries have been reported—and the source text describes this as a potential risk rather than confirmed harm. This fits the Moderate severity criterion for low-risk defects with no reported adverse events.

Plain-English summary

Medline Industries, LP is recalling select sterile convenience kits used for various surgical and medical procedures. The recall affects 80 different kit models, including tonsil packs, ENT packs, nasal packs, and head-and-neck packs. A total of 9,216 units have been distributed.

The kits are being recalled because the purchased breather pouches used for packaging may have open or weak seals. Breather pouches are designed to maintain sterility during storage and transport. Open or weak seals could compromise the sterility protection of the kits, potentially affecting their safety and efficacy when used in clinical settings.

The affected kits have been distributed nationwide throughout the United States, as well as to Canada, Mexico, Panama, and the U.S. Virgin Islands. Specific lot numbers and model numbers for all affected kits are available through the FDA or from Medline Industries.

Customers who have received affected kits should contact Medline Industries or their healthcare facility's quality assurance team to determine appropriate actions, which may include quarantine or return of affected product.

The recalled product

Product
Medline Convenience kits used for various procedures: 1) T A PACK, Model Number: DYNJ67791A; 2) NASAL PACK, Model Number: DYNJ66514; 3) ENT PACK, Model Number: DYNJ67775A; 4) T/A ENDO PACK, Model Number: DYNJ83158; 5) T & A PACK, Model Number: DYNJ0634878I; 6) PPM-IC
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Convenience Kits
Hazard
Affected units
9,216

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) DYNJ67791A
  • UDI-DI: 10193489941715(each)
  • 40193489941716(case)
  • Lot Number: 24IBE758
  • 2) DYNJ66514
  • UDI-DI: 10193489359282(each)
  • 40193489359283(case)
  • Lot Number: 24IBE817
  • 3) DYNJ67775A
  • UDI-DI: 10193489996258(each)
  • 40193489996259(case)
  • Lot Number: 24IBG346
  • 4) DYNJ83158
  • UDI-DI: 10195327236885(each)
  • 40195327236886(case)
  • Lot Number: 24IBG449
  • 5) DYNJ0634878I
  • UDI-DI: 10195327694500(each)
  • 40195327694501(case)
  • Lot Number: 24IBG548

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 34 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 34 products in this recall →

Related recalls

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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Same hazard · sterility compromise

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