CLASS II ONGOING Device recall · Reported 15 Apr 2026 · FDA Enforcement Report
Medical Ciaglia Blue Rhino Percutaneous Tracheostomy recalled
Cook is recalling Medical Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference. The recall was initiated on 5 Mar 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1781-2026
- FDA event ID
- 98495
- Recalling firm
- Cook, Bloomington, IN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Mar 2026
- FDA classified
- 6 Apr 2026
- Reported
- 15 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 5 Mar 2026 | Recall initiated by company | |
| 6 Apr 2026 | Classified by FDA | +32 days |
| 15 Apr 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Product as listed by the FDA
COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092; Reference Part Number C-PTIS-100-HC, Order Number G12115.
Where it was distributed
Worldwide distribution.
Questions about this recall
Why was it recalled?
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Which lots are affected?
Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270812(10)NS16200246, Lot Number NS16200246; Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270803(10)NS16189601, Lot Number NS16189601; Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270827(10)NS16226797, Lot Number NS16226797; Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270812(10)NS16200247, Lot Number NS16200247; Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270803(10)NS16189598, Lot Number NS16189598; Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270803(10)NS16189586, Lot Number NS16189586; Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270803(10)NS16189600, Lot Number NS16189600; Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270620(10)16120672, Lot Number 16120672; Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270803(10)NS16189607, Lot Number NS16189607; Reference Part Number C-PTIS-100-HC, UDI (01)00827002121157(17)270803(10)16189604, Lot Number 16189604; Reference Part Number C-PTIS-100-HC, UDI (01)00827002121157(17)270803(10)16189588, Lot Number 16189588; Reference Part Number C-PTIS-100-HC, UDI (01)00827002121157(17)270803(10)16189603, Lot Number 16189603; Reference Part Number C-PTIS-100-HC, UDI (01)00827002121157(17)270803(10)16189608, Lot Number 16189608; Reference Part Number C-PTIS-100-HC, UDI (01)00827002121157(17)270803(10)16189589, Lot Number 16189589; Reference Part Number C-PTIS-100-HC, UDI (01)00827002121157(17)270803(10)16189602, Lot Number 16189602; Reference Part Number C-PTIS-100-HC, UDI (01)00827002121157(17)270620(10)16120666, Lot Number 16120666; Reference Part Number C-PTIS-100-HC, UDI (01)00827002121157(17)270803(10)16189594, Lot Number 16189594.
Where was it sold?
Worldwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
17 other products · FDA event 98495This product is part of a recall event; the main page for the event is Medical Arterial Pressure Monitoring Tray, Reference recalled.
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| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |