The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1476-2022·Announced 2022-08-03

Medline Custom Surgical Kits Recalled for Leaking Isopropyl Alcohol Bottles

Medline has recalled custom neurosurgical procedure kits nationwide due to leaking bottles of isopropyl alcohol. The leakage poses a risk of contamination and chemical exposure during surgical procedures.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: FDA Class II recall of medical device kits with chemical leakage hazard. No illnesses or injuries reported. The leaking isopropyl alcohol constitutes a risk-of-harm product in sterile surgical environments where injury has not yet been documented, per rubric criterion for Score 3.

Plain-English summary

Medline Industries has recalled multiple models of custom neurosurgical procedure kits distributed nationwide. The recall affects 2,850 units of kits used in neurosurgery, including models for lumbar fusion, pediatric shunt placement, and spinal procedures.

The kits are being recalled because bottles of isopropyl alcohol within the kits are leaking. This leakage poses risks of contamination to sterile surgical environments and potential chemical exposure to surgical personnel and patients.

Healthcare facilities that received affected kits should immediately cease using them and contact Medline Industries for guidance on replacement and disposition. Affected kits can be identified by specific model numbers and lot codes provided in the recall notice.

The recalled product

Product
Medline Custom procedural kits labeled as follows: a. GP-NEURO PACK, b. KIT NEUR FUS LUM POST, c. KIT PEDI VP SHUNT, d. KIT STC NEURO SPINE GENERIC, e. MAIN BASIC NEURO, f. MAJOR NEURO PK-LF, g. NEURO, h. NEURO CERVICAL PACK, i. NINOR NEURO PK-LF, j. VP SHUNT PACK…
Manufacturer
MEDLINE INDUSTRIES, LP - SPT
Category
Medical Device — Surgical Procedure Kits
Hazard
Affected units
2,850

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)

  • Lot Code: a. Model Number DYNJ0397191V
  • Lot Numbers: 22CDC076
  • 22ADB021
  • 21KDC417
  • 21KDB423
  • 21GDA239
  • 21KDA879
  • b. Model Number DYKMBNDL138
  • Lot Numbers: 22OBC508
  • 22DBD203
  • 22BBT015
  • 22NBA962
  • 21GBG761
  • 21GBS468
  • 21HBN643
  • 21JBB951
  • 21LBL164
  • 21DBE120
  • 21FBE311
  • c. Model Number DYNJ907374

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by MEDLINE INDUSTRIES, LP - SPT 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 8 products in this recall →

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