Cook Medical extubation set labeled with an overstated expiration date
Cook Medical is recalling Staged Extubation Sets because affected lots were labeled with expiration dates that exceed the product's true shelf life. 95 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall where an overstated expiry date can lead to use of a sterile device beyond its validated shelf life, a risk of harm with no injuries reported.
Plain-English summary
Cook Medical is recalling the Cook Staged Extubation Set, reference part number C-CAE-14.0-83-EXTU, order number G24073, lot number 16010654. The action covers 95 units.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life of the product. A set carrying an overstated expiry can be held and used after the point at which its sterility and performance were validated. The FDA classified the action as Class II.
Distribution was worldwide. The sets are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the reference part number, UDI and lot number in the recall notice, quarantine it, and follow the instructions issued by Cook Medical.
The recalled product
- Product
- COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073
- Manufacturer
- Cook Incorporated
- Affected units
- 95
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Reference Part Number C-CAE-14.0-83-EXTU
- UDI (01)00827002240735(17)270509(10)16010654
- Lot Number 16010654.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 18 recalled by Cook Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 18 products in this recall →Related recalls
Same manufacturer · Cook Incorporated
See all →- ModerateCook Williams Cystoscopic Injection Needles Recalled for Manufacturing Defect
FDA (Devices) · 2026-10-21
- CriticalAurous Centimeter Sizing Catheter Recalled for Marker Band Cracking Risk
FDA (Devices) · 2026-05-13
- SevereBeacon Tip Centimeter Sizing Catheter recalled for cracking marker bands
FDA (Devices) · 2026-05-13
- CriticalCook Centimeter Sizing Catheter recall due to marker band cracking
FDA (Devices) · 2026-05-13
- HighCook Medical CTO-18 wire guides labeled with overstated expiration dates
FDA (Devices) · 2026-04-15
Same hazard · expiration date error
See all →- ModerateASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
- ModerateASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
- HighMentor Texas LP Recalls Expired Luer Lok Syringes Due to Distribution Error
FDA (Devices) · 2026-07-08
- HighCook Medical tracheostomy introducer sets labeled with overstated expiration dates
FDA (Devices) · 2026-04-15
- HighCook Medical chest tube tray labeled with an overstated expiration date
FDA (Devices) · 2026-04-15
Similar recalls
- ModerateCook Medical Biodesign Dural Graft Recalled for Incorrect Expiration Date and Instructions
FDA (Devices) · 2025-01-22
- ModerateCook Inc. Recalls Spectrum Central Venous Catheter Trays Due to Incorrect Expiration Dates
FDA (Devices) · 2020-04-01
- LowCook Inc. Recalls Pericardiocentesis Sets Due to Incorrect Expiration Dates
FDA (Devices) · 2020-04-01
- ModerateCook Drainage Catheter Recall: Incorrect Expiration Date Labels
FDA (Devices) · 2024-07-03
- HighApproach Hydro ST Micro Wire Guide Recalled for Incorrect Expiration Dates
FDA (Devices) · 2024-11-20
- HighHobbs Biliary Pigtail Stent Kits recalled due to incorrect expiration dates
FDA (Devices) · 2022-10-19