Class II U.S. Food and Drug Administration

Medline medical convenience kits labeled recall: Reports of problems with product being difficult to remove from patient

Recall published 5 days ago

Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.

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-0278-2027
Published
October 28, 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
146971 kits
Distribution
Nationwide
Made in
United States
Lot / code info
Medline Kit Number/SKU DYNJ40917B, UDI/DI 10195327599928 (each) 40195327599929 (case), Lot number 26HBB007; Medline Kit Number/SKU DYNJ905792F, UDI/DI 10198459411625 (each) 40198459411626 (case), Lot number 26FMH990; Medline Kit Number/SKU CDSCCR611R, UDI/DI 10198459001376 (each) 40198459001377 (case), Lot number 25KBM623; Medline Kit Number/SKU CDSCCR611S, UDI/DI 10198459610233 (each) 40198459610234 (case), Lot number 26HBE979; Medline Kit Number/SKU CDSCCR611S, UDI/DI 10198459610233 (each) 40198459610234 (case), Lot number 26GBK211; Medline Kit Number/SKU CDSCCR611S, UDI/DI 10198459610233 (each) 40198459610234 (case), Lot number 26EBK060; Medline Kit Number/SKU CDSCCR611S, UDI/DI 10198459610233 (each) 40198459610234 (case), Lot number 26ABQ736; Medline Kit Number/SKU CDSCCR611S, UDI/DI 10198459610233 (each) 40198459610234 (case), Lot number 26ABF499; Medline Kit Number/SKU CDS820031J, UDI/DI 10193489642971 (each) 40193489642972 (case), Lot number 26CMG521; Medline Kit Number/SKU CDS820031J, UDI/DI 10193489642971 (each) 40193489642972 (case), Lot number 25KBD161; Medline Kit Number/SKU CDS820075X, UDI/DI 10198459311550 (each) 40198459311551 (case), Lot number 26HMK631; Medline Kit Number/SKU CDS820075X, UDI/DI 10198459311550 (each) 40198459311551 (case), Lot number 26HME176; Medline Kit Number/SKU CDS820075X, UDI/DI 10198459311550 (each) 40198459311551 (case), Lot number 26DMH183; Medline Kit Number/SKU CDS820075X, UDI/DI 10198459311550 (each) 40198459311551 (case), Lot number 26CML334; Medline Kit Number/SKU CDS820075X, UDI/DI 10198459311550 (each) 40198459311551 (case), Lot number 26CMF519; Medline Kit Number/SKU CDS820075X, UDI/DI 10198459311550 (each) 40198459311551 (case), Lot number 26BMJ968; Medline Kit Number/SKU CDS820075X, UDI/DI 10198459311550 (each) 40198459311551 (case), Lot number 26BME738; Medline Kit Number/SKU CDS820075X, UDI/DI 10198459311550 (each) 40198459311551 (case), Lot number 26AMA219; Medline Kit Number/SKU CDS820075X, UDI/DI 10198459311550 (each) 40198459311551 (case), Lot number 25KMD732; Medline Kit Number/SKU CDS820075X, UDI/DI 10198459311550 (each) 40198459311551 (case), Lot number 25KMC115; Medline Kit Number/SKU CDS820081M, UDI/DI 10198459195556 (each) 40198459195557 (case), Lot number 26HBO918; Medline Kit Number/SKU CDS820081M, UDI/DI 10198459195556 (each) 40198459195557 (case), Lot number 26GBE928; Medline Kit Number/SKU CDS820081M, UDI/DI 10198459195556 (each) 40198459195557 (case), Lot number 26FBT832; Medline Kit Number/SKU CDS820081M, UDI/DI 10198459195556 (each) 40198459195557 (case), Lot number 26FBI622; Medline Kit Number/SKU CDS820081M, UDI/DI 10198459195556 (each) 40198459195557 (case), Lot number 26DBN561; Medline Kit Number/SKU CDS820081M, UDI/DI 10198459195556 (each) 40198459195557 (case), Lot number 25LBS107; Medline Kit Number/SKU CDS820136U, UDI/DI 10195327388751 (each) 40195327388752 (case), Lot number 26HBU105; Medline Kit Number/SKU CDS820136U, UDI/DI 10195327388751 (each) 40195327388752 (case), Lot number 26HBN475; Medline Kit Number/SKU CDS820136U, UDI/DI 10195327388751 (each) 40195327388752 (case), Lot number 26GBO938; Medline Kit Number/SKU CDS820136U, UDI/DI 10195327388751 (each) 40195327388752 (case), Lot number 26EBH832; Medline Kit Number/SKU CDS820136U, UDI/DI 10195327388751 (each) 40195327388752 (case), Lot number 26DBQ333; Medline Kit Number/SKU CDS830218J, UDI/DI 10888277530171 (each) 40888277530172 (case), Lot number 26GBV097; Medline Kit Number/SKU CDS830218J, UDI/DI 10888277530171 (each) 40888277530172 (case), Lot number 26FBM740; Medline Kit Number/SKU CDS980747M, UDI/DI 10198459382512 (each) 40198459382513 (case), Lot number 26GBU770; Medline Kit Number/SKU CDS980747M, UDI/DI 10198459382512 (each) 40198459382513 (case), Lot number 26GBI039; Medline Kit Number/SKU CDS980747M, UDI/DI 10198459382512 (each) 40198459382513 (case), Lot number 26CBV289; Medline Kit Number/SKU CDS980747M, UDI/DI 10198459382512 (each) 40198459382513 (case), Lot number 25KBG114; Me…
UPC codes
10195327599928, 40195327599929, 10198459411625, 40198459411626, 10198459001376, 40198459001377, 10198459610233, 40198459610234, 10193489642971, 40193489642972, 10198459311550, 40198459311551, 10198459195556, 40198459195557, 10195327388751, 40195327388752, 10888277530171, 40888277530172, 10198459382512, 40198459382513

Products covered by this recall

MEDLINE medical convenience kits labeled as: (list truncated)

Check your product

The notice names 61 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.

  • 10195327599928
  • 40195327599929
  • 10198459411625
  • 40198459411626
  • 10198459001376
  • 40198459001377
  • 10198459610233
  • 40198459610234
  • 10193489642971
  • 40193489642972
  • 10198459311550
  • 40198459311551
  • 10198459195556
  • 40198459195557
  • 10195327388751
  • 40195327388752
  • 10888277530171
  • 40888277530172
  • 10198459382512
  • 40198459382513

Lot or batch code

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

  • 26HBB007
  • 26FMH990
  • 25KBM623
  • 26HBE979
  • 26GBK211
  • 26EBK060
  • 26ABQ736
  • 26ABF499
  • 26CMG521
  • 25KBD161
  • 26HMK631
  • 26HME176
  • 26DMH183
  • 26CML334
  • 26CMF519
  • 26BMJ968
  • 26BME738
  • 26AMA219
  • 25KMD732
  • 25KMC115

Model or item number

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

  • DYNJ40917B
  • UDI/DI 10195327599928
  • DYNJ905792F
  • UDI/DI 10198459411625
  • CDSCCR611R
  • UDI/DI 10198459001376
  • CDSCCR611S
  • UDI/DI 10198459610233
  • CDS820031J
  • UDI/DI 10193489642971
  • CDS820075X
  • UDI/DI 10198459311550
  • CDS820081M
  • UDI/DI 10198459195556
  • CDS820136U
  • UDI/DI 10195327388751
  • CDS830218J
  • UDI/DI 10888277530171
  • CDS980747M
  • UDI/DI 10198459382512

Package size

Match the net weight or the piece count on the front of the pack.

  • 307 L

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 — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

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?

Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10195327599928, 40195327599929, 10198459411625; lot code 26HBB007, 26FMH990, 25KBM623; model number DYNJ40917B, UDI/DI 10195327599928, DYNJ905792F. 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?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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