Class II U.S. Food and Drug Administration

Stryker Sustainability Solutions REF:B12LT Ethicon Endo-Surgery recall: Reusable access port system may crack or seperate during use

Recall published last month

Reusable access port system may crack or seperate during use.

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: Reusable access port system may crack or seperate 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-3185-2026
Published
September 23, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Stryker Sustainability Solutions
Product type
Medical devices
Units affected
2682 units
Distribution
Nationwide
Made in
United States
Lot / code info
UDI: (01)00885825020897/ Lots: 16029001 16032878 16038822 16041414 16044000 16048542 16052751 16054119 16062169 16062738 16066292 16074632 16087947 16087952 16090650 16098040 16107246 16111434 16115899 16115909 16120868 16130680 16130701 16135456 16136279 16138395 16140432 16140568 16142544 16142619 16159304 16160563 16172080 16176548 16186738 16186874 16187194 16187248 16187457 16197336 16201786 16205783 16205810 16205823 16206753 16220653 16220918 16221448 16221453
UPC codes
00885825020897

Products covered by this recall

REF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MM

Check your product

The notice names 3 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.

  • 00885825020897

Model or item number

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

  • B12LT Ethicon Endo-Surgery
  • Inc. XCEL BLADELESS TRO

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

Stryker Sustainability Solutions — 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. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

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: Stryker Sustainability Solutions — 1810 W Drake Dr, Tempe, AZ, 85283-4327

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 Stryker Sustainability Solutions medical devices recalled?

Reusable access port system may crack or seperate during use. Reusable access port system may crack or seperate during use.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00885825020897; model number B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TRO. 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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