The Recall Desk
HighFDA (Devices)·Z-1610-2025·Announced 2025-04-23

Medline Sterile Convenience Kits Recalled for Breather Pouch Sealing Defect

Medline Industries has recalled five sterile convenience kits for various neurosurgical and implant procedures due to potential open or weak seals on breather pouches used in packaging. The defect could compromise sterility of the devices.

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 recall involving sterile medical device convenience kits where a packaging defect (open/weak seals) could compromise sterility and introduce contamination. The source text does not report any illnesses or injuries, and this is FDA Class II. The hazard—sterility breach—poses potential risk to patients, meeting the High severity threshold for products where injury risk exists but has not yet been reported.

Plain-English summary

Medline Industries, LP is recalling five sterile convenience kit models due to a potential for open or weak seals on breather pouches used for packaging these kits. The affected products include NEURO PACK WRO-LF (Model DYNJ41856C), STIM IMPLANT PACK (Model DYNJ53032C), WMC VP SHUNT PACK-LF (Model DYNJ50629M), SHUNT PACK (Model DYNJ40040C), and STIM IMPLANT PACK (Model DYNJ53032C). A total of 354 units have been distributed.

The affected kits have been distributed worldwide, including throughout the United States, Canada, Mexico, Panama, and the Virgin Islands. Specific lot numbers are identified for each model.

Customers who have purchased any of the recalled kits should stop using them and contact Medline Industries for further instructions regarding returns or replacements. Healthcare providers and facilities using these convenience kits should verify that their inventory does not include any of the recalled lot numbers listed in this recall.

The recalled product

Product
Medline Convenience kits used for various procedures: 1) NEURO PACK WRO-LF, Model Number: DYNJ41856C; 2) STIM IMPLANT PACK, Model Number: DYNJ53032C; 3) WMC VP SHUNT PACK-LF, Model Number: DYNJ50629M; 4) SHUNT PACK, Model Number: DYNJ40040C; 5) STIM IMPLANT PACK, Model N
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Convenience Kits / Neurosurgical Implants
Hazard
Affected units
354

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 (18)

  • 1) DYNJ41856C
  • UDI-DI: 10195327429010(each)
  • 40195327429011(case)
  • Lot Number: 24JBM711
  • 2) DYNJ53032C
  • UDI-DI: 10195327494094(each)
  • 40195327494095(case)
  • Lot Number: 24JBN788
  • 3) DYNJ50629M
  • UDI-DI: 10198459146985(each)
  • 40198459146986(case)
  • Lot Number: 24JBW674
  • 4) DYNJ40040C
  • UDI-DI: 10889942683970(each)
  • 40889942683971(case)
  • Lot Number: 24KBC507
  • 5) DYNJ53032C
  • Lot Number: 24KBC655

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 →

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Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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Same hazard · packaging defect

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