Class II U.S. Food and Drug Administration

Medline Industries, LP Convenience Kits containing Conmed AirSeal Access Ports CHN GYN recall: Kits contain CONMED AirSeal Access Ports. The ports were recalled

Recall published 7 days ago

Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.

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: Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.

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-0183-2027
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
3,551 kits
Distribution
Nationwide
Made in
United States
Lot / code info
DYNJ906731K UDI-DI 10195327436346 Lots 24ADB566 24CDB291 24CDB969 24GDB449 24JDA590 24KDB303 25BDB494 25CDA446 25EDB457 25FDA837 25FDB582 25GDA082 DYNJ906731L UDI-DI 10198459403675 Lots 25HDB211 25JDA226 DYNJ906731N UDI-DI 10198459758249 Lots 26EDA043 26FDB001 26FDB487 DYNJG901002A UDI-DI 10195327401481 Lot 24BLA300 DYNJG901002B UDI-DI 10195327677145 Lots 24GLA290 24ILA519 24JLA479 24LLA939 25ALA154 25ELA210 25FLA112 25GLA399 25HLA560 DYNJG901002C UDI-DI 10198459545672 Lots 25JLA619 25KLA897 26ALA207 26BLA625 26CLA984 DYNJG901002D UDI-DI 10198459723742 Lots 26ELA161 26ELA744 26GLA765 26HLA179 DYNJG901004B UDI-DI 10195327677138 Lots 24FLA735 24GLA836 24KLA502 25ALA409 25ALA837 25DLA322 25ELA451 25FLA291 25GLB051 25HLA207 25ILA840 25JLA027 25JLA621 DYNJG901004D UDI-DI 10198459723759 Lots 26DLA382 26ELA743 26FLB123 DYNJ911258A UDI-DI 10198459582097 Lot 26AMF842 DYKMBNDL116D UDI-DI 10195327608866 Lots 24CBF889 24DBA349 DYKMBNDL116F UDI-DI 10198459000706 Lots 24DBS388 24FBC411 24GBK948 24IBV184 24JBB328 DYNJ907827F UDI-DI 10195327345365 Lots 24ABV361 24CBM651 24DBD866 24GBH678 DYNJ50474G UDI-DI 10198459140235 Lots 24KDA630 25ADB023 25BDB826 25CDB231 25DDA066 25HDA254 25JDA520 25LDA008 25LDC029 26DDA900 26FDA459 26FDB573 DYNJ63392C UDI-DI 10195327634643 Lots 24BLA318 24CLA990 24ELA575 24FLA977 24HLA137 24ILA935 DYNJ63392F UDI-DI 10198459315572 Lots 25DLA944 25ELA626 25FLA272 25GLA905 25HLA240 25HLA894 25JLA091 25KLA775 25LLA985 26ALA670 26DLB121 26FLA701
UPC codes
10195327436346, 10198459403675, 10198459758249, 10195327401481, 10195327677145, 10198459545672, 10198459723742, 10195327677138, 10198459723759, 10198459582097, 10195327608866, 10198459000706, 10195327345365, 10198459140235, 10195327634643, 10198459315572

Products covered by this recall

Convenience Kits containing CONMED AirSeal Access Ports CHN GYN ONCOLOGY DYNJ906731K DYNJ906731L DYNJ906731N DAVINCI PROSTATECTOMY DYNJG901002A DYNJG901002B DYNJG901002C DYNJG901002D GENERAL DAVINCI DYNJG901004B DYNJG901004D HERNANDEZ DAVINCI ACC BUNDLE M DYNJ911258A KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116D DYKMBNDL116F ROBOTIC GYN DYNJ907827F ROBOTIC PACK DYNJ50474G RR-DAVINCI PROSTATE ACCESSORY DYNJ63392C DYNJ63392F

Check your product

The notice names 18 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.

  • 10195327436346
  • 10198459403675
  • 10198459758249
  • 10195327401481
  • 10195327677145
  • 10198459545672
  • 10198459723742
  • 10195327677138
  • 10198459723759
  • 10198459582097
  • 10195327608866
  • 10198459000706
  • 10195327345365
  • 10198459140235
  • 10195327634643
  • 10198459315572

Lot or batch code

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

  • 24BLA300 DYNJG901002B UDI-DI 10195327677145
  • 26AMF842 DYKMBNDL116D UDI-DI 10195327608866

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?

Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures. Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10195327436346, 10198459403675, 10198459758249; lot code 24BLA300 DYNJG901002B UDI-DI 10195327677145, 26AMF842 DYKMBNDL116D UDI-DI 10195327608866. 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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