Reported Apr 15, 2026 · Ongoing
COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set
Cook Incorporated
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: Cook Incorporated · 750 N Daniels Way · Bloomington, IN · 47404-9120
Is this the product you have?
20 of 20 products
| Model / number | Barcodes | Product as published |
|---|---|---|
C-PTIS-100-HC-G-EU | 00827002576858 | Reference , UDI (01)00827002576858(17)270802(10)16189446, Lot Number 16189446 |
C-PTIS-100-HC-G-EU | 00827002576858 | Reference , UDI (01)00827002576858(17)270803(10)16189593, Lot Number 16189593 |
C-PTIS-100-HC-G-EU | 00827002576858 | Reference , UDI (01)00827002576858(17)270725(10)16175956, Lot Number 16175956 |
C-PTIS-100-HC-G-EU | 00827002576858 | Reference , UDI (01)00827002576858(17)270725(10)16175957, Lot Number 16175957 |
C-PTIS-100-HC-G-EU | 00827002576858 | Reference , UDI (01)00827002576858(17)270803(10)16189597, Lot Number 16189597 |
C-PTIS-100-HC-G-EU | 00827002576858 | Reference , UDI (01)00827002576858(17)270725(10)16175953, Lot Number 16175953 |
C-PTIS-100-HC-G-EU | 00827002576858 | Reference , UDI (01)00827002576858(17)271001(10)16460934, Lot Number 16460934 |
C-PTIS-100-HC-G-NA | 00827002576827 | Reference , UDI (01)00827002576827(17)280318(10)16514949, Lot Number 16514949 |
C-PTIS-100-HC-G-NA | 00827002576827 | Reference , UDI (01)00827002576827(17)270725(10)16175948, Lot Number 16175948 |
C-PTIS-100-UNL-HC-G-EU | 00827002576872 | Reference , UDI (01)00827002576872(17)260101(10)15151627, Lot Number 15151627 |
C-PTIS-100-UNL-HC-G-EU | 00827002576872 | Reference , UDI (01)00827002576872(17)270627(10)16131781, Lot Number 16131781 |
C-PTIS-100-UNL-HC-G-EU | 00827002576872 | Reference , UDI (01)00827002576872(17)280218(10)16471138, Lot Number 16471138 |
C-PTIS-100-UNS-HC-G-EU | 00827002576865 | Reference , UDI (01)00827002576865(17)270725(10)16175951, Lot Number 16175951 |
C-PTIS-100-UNS-HC-G-EU | 00827002576865 | Reference , UDI (01)00827002576865(17)270725(10)16175949, Lot Number 16175949 |
C-PTIS-100-UNS-HC-G-EU | 00827002576865 | Reference , UDI (01)00827002576865(17)270724(10)16174015, Lot Number 16174015 |
C-PTIS-100-UNS-HC-G-EU | 00827002576865 | Reference , UDI (01)00827002576865(17)270725(10)16175955, Lot Number 16175955 |
C-PTIS-100-UNS-HC-G-EU | 00827002576865 | Reference , UDI (01)00827002576865(17)270724(10)16174023, Lot Number 16174023 |
C-PTIS-100-UNS-HC-G-EU | 00827002576865 | Reference , UDI (01)00827002576865(17)270801(10)16187746, Lot Number 16187746 |
C-PTIS-100-UNS-HC-G-EU | 00827002576865 | Reference , UDI (01)00827002576865(17)260327(10)15548776, Lot Number 15548776 |
C-PTIS-100-UNS-HC-G-EU | 00827002576865 | Reference , UDI (01)00827002576865(17)280121(10)16429827, Lot Number 16429827. |
- Amount recalled
- 916 units
This recall covers 18 products
The agency filed one notice per product. You are reading one of them; the other 17 are below.
5 more are in the archive.
Why it was recalled
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
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.
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