Class II U.S. Food and Drug Administration

Medline convenience kits labeled as: 1) GYN Robotic CDS recall: Kits contain a potentially contaminated component which were recalled

Recall published last month

Kits contain a potentially contaminated component which were recalled by the manufacturer

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: Kits contain a potentially contaminated component which were recalled by the manufacturer

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-3025-2026
Published
September 2, 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
1349 kits
Distribution
Nationwide
Made in
United States
Lot / code info
Medline Kit SKU CDS982888Q, UDI/DI 10198459521959 (each) 40198459521950 (case), Lot Number 26FBU894; Medline Kit SKU CDS982888Q, UDI/DI 10198459521959 (each) 40198459521950 (case), Lot Number 26BBF959; Medline Kit SKU DYNJ43837D, UDI/DI 10195327657222 (each) 40195327657223 (case), Lot Number 25KMH001; Medline Kit SKU DYNJ89759, UDI/DI 10198459289286 (each) 40198459289287 (case), Lot Number 26ABN671; Medline Kit SKU DYNJ89759, UDI/DI 10198459289286 (each) 40198459289287 (case), Lot Number 25JBT511; Medline Kit SKU DYNJ89781, UDI/DI 10198459289521 (each) 40198459289522 (case), Lot Number 26DBT722; Medline Kit SKU DYNJ89781, UDI/DI 10198459289521 (each) 40198459289522 (case), Lot Number 25JBL333; Medline Kit SKU DYNJ900203N, UDI/DI 10198459510144 (each) 40198459510145 (case), Lot Number 25KBF320; Medline Kit SKU DYNJ900203N, UDI/DI 10198459510144 (each) 40198459510145 (case), Lot Number 25JBS159; Medline Kit SKU DYNJ900541Q, UDI/DI 10198459602283 (each) 40198459602284 (case), Lot Number 26AMH304; Medline Kit SKU DYNJ900541Q, UDI/DI 10198459602283 (each) 40198459602284 (case), Lot Number 26AME001; Medline Kit SKU DYNJ903485K, UDI/DI 10198459255083 (each) 40198459255084 (case), Lot Number 26ADA977; Medline Kit SKU DYNJ903485K, UDI/DI 10198459255083 (each) 40198459255084 (case), Lot Number 25HDB674; Medline Kit SKU DYNJ905230K, UDI/DI 10198459520532 (each) 40198459520533 (case), Lot Number 25KBN172; Medline Kit SKU DYNJ906013I, UDI/DI 10198459501616 (each) 40198459501617 (case), Lot Number 25KBH190; Medline Kit SKU DYNJ909394B, UDI/DI 10198459556579 (each) 40198459556570 (case), Lot Number 25KBE469; Medline Kit SKU DYNJ909526B, UDI/DI 10198459539886 (each) 40198459539887 (case), Lot Number 26AMD191; Medline Kit SKU DYNJ909526C, UDI/DI 10198459716799 (each) 40198459716790 (case), Lot Number 26DMF990; Medline Kit SKU DYNJ910180, UDI/DI 10195327609627 (each) 40195327609628 (case), Lot Number 25IBP437; Medline Kit SKU DYNJ910181, UDI/DI 10195327609733 (each) 40195327609734 (case), Lot Number 25ILA566; Medline Kit SKU DYNJ910181A, UDI/DI 10198459556586 (each) 40198459556587 (case), Lot Number 25KLA664; DYNJ912062, UDI/DI 10198459611025 (each) 40198459611026 (case), Lot Number 26CBS107.
UPC codes
10198459521959, 40198459521950, 10195327657222, 40195327657223, 10198459289286, 40198459289287, 10198459289521, 40198459289522, 10198459510144, 40198459510145, 10198459602283, 40198459602284, 10198459255083, 40198459255084, 10198459520532, 40198459520533, 10198459501616, 40198459501617, 10198459556579, 40198459556570

Products covered by this recall

Medline convenience kits labeled as: 1) GYN ROBOTIC CDS, Medline Kit SKU CDS982888Q; 2) GYN ROBOTIC ADD ON PACK, Medline Kit SKU DYNJ43837D; 3) OH GYN/LAP ROBOT PACK, Medline Kit SKU DYNJ89759; 4) GYN LAPAROSCOPY PACK, Medline Kit SKU DYNJ89781; 5) ROBOT ME RF, Medline Kit SKU DYNJ900203N; 6) GYN LAPAROSCOPY, Medline Kit SKU DYNJ900541Q; 7) ROBOTIC, Medline Kit SKU DYNJ903485K; 8) ROBOTIC GYN, Medline Kit SKU DYNJ905230K; 9) LAPAROSCOPIC GYN AND COLON, Medline Kit SKU DYNJ906013I; 10) GYN LAPAROSCOPIC PACK, Medline Kit SKU DYNJ909394B; 11) GYN ROBOTIC, Medline Kit SKU DYNJ909526B; 12) GYN ROBOTIC, Medline Kit SKU DYNJ909526C; 13) GYN ONC ROBOTIC, Medline Kit SKU DYNJ910180; 14) GYN ROBOTIC, Medline Kit SKU DYNJ910181; 15) GYN ROBOTIC, Medline Kit SKU DYNJ910181A; 16) ROBOTICS, Medline Kit SKU DYNJ912062.

Check your product

The notice names 60 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.

  • 10198459521959
  • 40198459521950
  • 10195327657222
  • 40195327657223
  • 10198459289286
  • 40198459289287
  • 10198459289521
  • 40198459289522
  • 10198459510144
  • 40198459510145
  • 10198459602283
  • 40198459602284
  • 10198459255083
  • 40198459255084
  • 10198459520532
  • 40198459520533
  • 10198459501616
  • 40198459501617
  • 10198459556579
  • 40198459556570

Lot or batch code

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

  • 26FBU894
  • 26BBF959
  • 25KMH001
  • 26ABN671
  • 25JBT511
  • 26DBT722
  • 25JBL333
  • 25KBF320
  • 25JBS159
  • 26AMH304
  • 26AME001
  • 26ADA977
  • 25HDB674
  • 25KBN172
  • 25KBH190
  • 25KBE469
  • 26AMD191
  • 26DMF990
  • 25IBP437
  • 25ILA566

Model or item number

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

  • CDS982888Q
  • DYNJ43837D
  • DYNJ89759
  • DYNJ89781
  • DYNJ900203N
  • DYNJ900541Q
  • DYNJ903485K
  • DYNJ905230K
  • DYNJ906013I
  • DYNJ909394B
  • DYNJ909526B
  • DYNJ909526C
  • DYNJ910180
  • DYNJ910181
  • DYNJ910181A
  • UDI
  • DI 10
  • DI 10198459521959
  • DI 10195327657222
  • DI 10198459289286

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?

Kits contain a potentially contaminated component which were recalled by the manufacturer Kits contain a potentially contaminated component which were recalled by the manufacturer

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10198459521959, 40198459521950, 10195327657222; lot code 26FBU894, 26BBF959, 25KMH001; model number CDS982888Q, DYNJ43837D, DYNJ89759. 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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