Reported Nov 5, 2025 · Ongoing
Brand Name
Alcon Research LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alcon Research LLC · 6201 South Fwy · Fort Worth, TX · 76134-2099
Is this the product you have?
Brand Name
5 of 5 products
| Model / number | Product as published |
|---|---|
27GA | Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000356 |
25GA | HP ENTRY SYSTEM, 4 MM 1 COUNT 8065000358 |
27GA | HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000359 |
25GA | HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000467 |
27GA | INFUSION CANNULA(4&6MM ES)+TRAY+TMD 8065000468 |
- Lot codes and dates
- Catalog Number8065000356
- UDI-DI code00380650003560
- Lot/Batch Numbers17CFND
- Catalog Number8065000358
- UDI-DI code00380650003584
- Lot/Batch Numbers17CMKW 17DR9L
- Catalog Number8065000359
- UDI-DI code00380650003591
- Lot/Batch Number17DWCY
- Catalog Number8065000467
- UDI-DI code00380650004673
- Lot/Batch Number17CP3T
- Catalog Number8065000468
- UDI-DI code00380650004680
- Lot/Batch Number17CP3U
- Amount recalled
- 1632
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Due to incomplete seals in the pouch which provide the sterile barrier.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new packaged foods recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.