CLASS II ONGOING Device recall · Reported 15 Apr 2026 · FDA Enforcement Report
Medical Wayne Pneumothorax Tray: Reference recalled by Cook Incorporated
Cook Incorporated is recalling Cook Medical Wayne Pneumothorax Tray: 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-1792-2026
- FDA event ID
- 98495
- Recalling firm
- Cook Incorporated, 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
- Other Medical 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 Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537.
Where it was distributed
Worldwide distribution.
Questions about this recall
Is Medical Wayne Pneumothorax Tray: Reference recalled?
Yes. Cook Incorporated recalled Medical Wayne Pneumothorax Tray: Reference on 5 Mar 2026. The recall is Class II and its status is Ongoing. Recall number Z-1792-2026.
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-UTPTY-1400-WAYNE-112497-IMH, UDI (01)00827002565371(17)261020(10)15719344X, Lot Number 15719344X; Reference Part Number C-UTPTY-1400-WAYNE-112497-IM , UDI (01)00827002565371(17)261018(10)15714808X, Lot Number 15714808X; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, UDI (01)00827002565371(17)260115(10)15834145, Lot Number 15834145; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, UDI (01)00827002565371(17)260115(10)15834147, Lot Number 15834147.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Cook Incorporated
All 85| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Beacon Tip Centimeter Sizing Catheter RPN/GPN recalled | Cook Incorporated | Sterility | Nationwide |
| Device | CLASS I | Aurous Centimeter Sizing Catheter RPN recalled by Cook Incorporated | Cook Incorporated | Sterility | Nationwide |
| Device | CLASS I | Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-Pig-csc recalled | Cook Incorporated | Device Malfunction | Nationwide |
| Device | CLASS II | Medical Cook Staged Extubation Set: Reference recalled | Cook Incorporated | Other | IN |
| Device | CLASS II | Medical Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference recalled | Cook Incorporated | Other | IN |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |