Class II U.S. Food and Drug Administration

Medline surgical convenience kits labeled as: 1) Neuro-Spine Basin recall: Medical convenience kits were distributed containing cannula components

Recall published 7 days ago

Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0177-2027
Published
October 21, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medline Industries, LP
Product type
Medical devices
Units affected
1900 kits
Distribution
Nationwide
Made in
United States
Lot / code info
Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 26BBC545; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 26ABM193; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 25LBD334; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 25JBL305; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 25IBF209; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 25HBI041; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 25FBF808; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 25EBO692; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 25DBG912; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 25BBS302; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 25ABN459; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 24LBQ417; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 24KBL387; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 24KBB074; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 24IBI827; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 24HBL301; Medline product number/SKU DYNJ24528M, UDI/DI 10193489678222 (each) 40193489678223 (case), Lot number 22CLA280; Medline product number/SKU DYNJ24528M, UDI/DI 10193489678222 (each) 40193489678223 (case), Lot number 22ALA687; Medline product number/SKU DYNJ24528M, UDI/DI 10193489678222 (each) 40193489678223 (case), Lot number 21KLA284; Medline product number/SKU DYNJ24528M, UDI/DI 10193489678222 (each) 40193489678223 (case), Lot number 21JLA298; Medline product number/SKU DYNJ24528M, UDI/DI 10193489678222 (each) 40193489678223 (case), Lot number 21HLA613; Medline product number/SKU DYNJ24528M, UDI/DI 10193489678222 (each) 40193489678223 (case), Lot number 21GLA706; Medline product number/SKU DYNJ24528M, UDI/DI 10193489678222 (each) 40193489678223 (case), Lot number 21DLA076; Medline product number/SKU DYNJ24528M, UDI/DI 10193489678222 (each) 40193489678223 (case), Lot number 21ALA482; Medline product number/SKU DYNJ24528M, UDI/DI 10193489678222 (each) 40193489678223 (case), Lot number 20LLA600.
UPC codes
10198459093425, 40198459093426, 10193489678222, 40193489678223

Products covered by this recall

Medline surgical convenience kits labeled as: 1) NEURO-SPINE BASIN PACK, Medline Product Number/SKU DYNJ80055A; 2) AV SHUNT PACK-LF, Medline Product Number/SKU DYNJ24528M.

Check your product

The notice names 28 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10198459093425
  • 40198459093426
  • 10193489678222
  • 40193489678223

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 26BBC545
  • 26ABM193
  • 25LBD334
  • 25JBL305
  • 25IBF209
  • 25HBI041
  • 25FBF808
  • 25EBO692
  • 25DBG912
  • 25BBS302
  • 25ABN459
  • 24LBQ417
  • 24KBL387
  • 24KBB074
  • 24IBI827
  • 24HBL301
  • 22CLA280
  • 22ALA687
  • 21KLA284
  • 21JLA298

Model or item number

On the rating label, the box or the instruction sheet.

  • DYNJ80055A
  • DYNJ24528M
  • UDI/DI 10198459093425
  • UDI/DI 10193489678222

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Medline Industries, LP — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Medline Industries, LP — 3 Lakes Dr, Northfield, IL, 60093-2753

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medline Industries, LP medical devices recalled?

Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use. Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10198459093425, 40198459093426, 10193489678222; lot code 26BBC545, 26ABM193, 25LBD334; model number DYNJ80055A, DYNJ24528M, UDI/DI 10198459093425. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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