Class II U.S. Food and Drug Administration

GRI Medical & Electronic Technology Co., Ltd. Halyard Laparoscopy Comprehensive Pack recall: Laparoscopy packs labeled as "latex free" were found to contain a latex

Recall published 11 days ago

Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter

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: Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter

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-0077-2027
Published
October 14, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
GRI Medical & Electronic Technology Co., Ltd.
Product type
Medical devices
Units affected
396 kits
Distribution
Nationwide
Made in
China
Lot / code info
UDI-DI: 10680651493320 (unit level), 30680651493324 (case level) Lot Numbers: GL25271CXA-Expiry Date: 2029/3/30; GL25296CXA-Expiry Date: 2029/3/30; GL26076CXA-Expiry Date: 2029/5/31
UPC codes
10680651493320, 30680651493324

Products covered by this recall

HALYARD Laparoscopy Comprehensive Pack II REF: 49332

Check your product

The notice names 6 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.

  • 10680651493320
  • 30680651493324

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 2029
  • 30
  • 31 — 396 kits

Model or item number

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

  • 49332 — UDI-DI

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

GRI Medical & Electronic Technology Co., Ltd. — 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. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

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: GRI Medical & Electronic Technology Co., Ltd. — 1805 Honggao Road, Jia Xing

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 GRI Medical & Electronic Technology Co., Ltd. medical… recalled?

Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10680651493320, 30680651493324; best-by date 2029 or 30; model number 49332 — UDI-DI. 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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