Lower risk Medical device recall · FDA · Published October 22, 2018

WOM World of Medicine recalls PNEUMOC: Heated High-Flow Tube Set packaging risk

WOM World of Medicine recalls PNEUMOCLEAR Heated High-Flow Tube Sets due to potential packaging damage from tube prongs. This single-use sterile set is used with C02 insufflators for laparoscopic procedures.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0508-2019Medical device WOM World of Medicine ›

Lower-risk recall

It is possible that the packaging of the product can be damaged by the prongs on the tube set.

Take action

Contact the company

Recalling firmWOM World of Medicine AGSalzufer 8 · Berlin, Germany

✎ GovInfoNow plain-language explainer

WOM World of Medicine is recalling PNEUMOCLEAR Heated High-Flow Tube Sets because the packaging might get damaged by the tube prongs. This could affect the tube set's sterility and safety during medical procedures. Read more at govinfonow.com/recall/69572-wom-world-of-medicine-recalls-pneumoc-heated-high-flow-tube.

Source Summary by GovInfoNow · govinfonow.com/recall/69572-wom-world-of-medicine-recalls-pneumoc-heated-high-flow-tube · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0508-2019

Cite this page

“WOM World of Medicine recalls PNEUMOC: Heated High-Flow Tube Set packaging risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69572-wom-world-of-medicine-recalls-pneumoc-heated-high-flow-tube. Based on FDA recall #Z-0508-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0508-2019%22&limit=1).

WOM World of Medicine AG recalled PNEUMOCLEAR Heated High-Flow Tube Sets on Oct. 22, 2018, according to the FDA. The agency said damaged packaging could result from prongs on the tube set.

How to tell if you have it

Brand: WOM World of Medicine
Product: PNEUMOCLEAR Heated High-Flow Tube Set
Lots: 4011926 to 4013513 (ALL)
Quantity: 124,180 tube sets

The hazard

The FDA said it is possible that the packaging of the product can be damaged by the prongs on the tube set.

Context

GovInfoNow's records show WOM World Of Medicine AG has 4 other recalls on record since 2019-08-14. Other recent recalls of similar products include Boston Scientific EndoVive Safety PEG Kit Recall (2026-02-10), Erbe Medical CleverCap CO2 Tubing/Cap Set Recall (2026-03-31) and Windstone Custom Convenience Kits Pre Op Kit Recall (2026-03-11).

How to tell if you have this one

Check for PNEUMOCLEAR Heated High-Flow Tube Sets with lot numbers from 4011926 to 4013513. These were sold as single-use sterile sets for laparoscopic procedures.

Brand
WOM World of Medicine
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Identify the lot number on the packaging to confirm if it falls within 4011926 to 4013513.

Where it went and when

Where it was distributed

Distributed in California, and outside the U.S.

FDA distribution: “Worldwide Distribution - US in the state of California and country of Netherlands” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California.

Recall timeline

FDA terminated this recall 2.5 years after the firm started it.

Oct 22, 2018Firm started the recall
Nov 27, 2018FDA classified it Class II
Dec 5, 2018Published in FDA’s Enforcement Report
May 6, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More WOM World of Medicine recalls

Link to this recall

<a href="https://govinfonow.com/recall/69572-wom-world-of-medicine-recalls-pneumoc-heated-high-flow-tube">WOM World of Medicine recalls PNEUMOC: Heated High-Flow Tube Set packaging risk (GovInfoNow)</a>

Where this comes from

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-0508-2019 (October 22, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0508-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.