Lower riskMedical device recall · FDA · Published September 17, 2019
Cook Pneumothorax Tray Recall: Sterility Risk in Modified Wayne Sets
Cook recalls Pneumothorax Trays with Catalog No. C-UTPTY-1400-WAYNE-112497-IMH for potential sterility compromise in modified Wayne sets. Affected units may have lidstock perforation lines over sterile areas.
Lidstock perforation line may be over the sterile area of the tray, when it should be on the lip of the tray, potentially compromising the sterility of the device.
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Contact the company
📍Recalling firmCook Inc.750 N Daniels Way · Bloomington, IN 47404-9120
✎ GovInfoNow plain-language explainer
Cook is recalling Pneumothorax Trays with specific catalog numbers due to a risk that the lidstock perforation line might be over the sterile area instead of the tray lip. This could compromise sterility during medical procedures, especially for modified Wayne sets used in pneumothorax treatment. Read more at govinfonow.com/recall/67004-cook-pneumothorax-tray-recall-sterility-risk-in-modified-wayne-sets.
“Cook Pneumothorax Tray Recall: Sterility Risk in Modified Wayne Sets.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67004-cook-pneumothorax-tray-recall-sterility-risk-in-modified-wayne-sets. Based on FDA recall #Z-0506-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0506-2020%22&limit=1).
The FDA announced on September 17, 2019, that Cook Inc. is recalling Pneumothorax Trays because a lidstock perforation line may compromise sterility. The agency classified the recall as Class II.
How to tell if you have it
Brand: Cook
Product: Pneumothorax Tray
Catalog No.: C-UTPTY-1400-WAYNE-112497-IMH
GPN: G56537
Lot code: 9850522
The hazard
The modified Wayne Pneumothorax Set is used for the relief of simple, spontaneous, iatrogenic, and tension pneumothorax. The hazard involves a lidstock perforation line that may be over the sterile area of the tray instead of on the lip, potentially compromising sterility.
Context
GovInfoNow's records show Cook Inc. has issued 38 other recalls since July 31, 2017. Recent Cook recalls include a November 12, 2021, check-flo introducer mislabeling risk and an October 13, 2021, skinny needle debris recall. Other recent recalls of similar products include the March 5, 2026, Cook Medical Wayne Pneumothorax Tray expiration issue, the June 1, 2026, Argon Medical Devices sterility risk, and the January 7, 2026, Medline Basic Nerve Block Tray sterility risk.
How to tell if you have this one
Check for Catalog No. C-UTPTY-1400-WAYNE-112497-IMH or GPN G56537 on the tray. The product is part of the modified Wayne Pneumothorax Set used for pneumothorax treatment.
Brand
Cook
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the catalog number and GPN code on the tray to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 8 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of CA, FL, IN, MI, MT, NC, NY, OH.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Indiana, Michigan, Montana, New York, North Carolina, Ohio.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0506-2020 (September 17, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0506-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.