Covidien Adult-Pediatric Electrostatic Filter HME: Potential Ethylene Oxide Sterilization
Covidien recalls adult-pediatric electrostatic filter HME (item code 352/5877Z) due to potential deviations in ethylene oxide sterilization processes. This product is used for single-use anesthesia and respiratory care. Affected units have specific lot numbers and were sold with certain GTINs.
Lower-risk recall
The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.
Contact the company
What happened, in plain English
Covidien is recalling adult-pediatric electrostatic filters used in anesthesia and respiratory care because their sterilization process may have been compromised. This could lead to improper sterilization, risking infection for patients during medical procedures. Read more at govinfonow.com/recall/62639-covidien-adult-pediatric-electrostatic-filter-hme-potential-ethylene-oxide-sterilization.
Source Summary by GovInfoNow · govinfonow.com/recall/62639-covidien-adult-pediatric-electrostatic-filter-hme-potential-ethylene-oxide-sterilization · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1868-2021
Cite this page
“Covidien Adult-Pediatric Electrostatic Filter HME: Potential Ethylene Oxide Sterilization.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62639-covidien-adult-pediatric-electrostatic-filter-hme-potential-ethylene-oxide-sterilization. Based on FDA recall #Z-1868-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1868-2021%22&limit=1).
Why it’s dangerous
The filters were potentially sterilized using ethylene oxide in a process that deviated from validated parameters. This could mean the filters are not properly sterilized, increasing the risk of infection for patients during medical procedures.
Who’s affected
Healthcare professionals using these filters for anesthesia or respiratory care patients are most at risk. Patients receiving the filters during medical procedures could be exposed to potential contamination.
How to tell if you have this one
Check for the item code 352/5877Z on the packaging. The product is used for single-use anesthesia and respiratory care. Affected units have specific lot numbers listed in the recall notice.
- Brand
Covidien- Category
Medical device
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Worldwide distribution - US Nationwide distribution in the states of DE, KY, NY, TX, VA, VT, and WA. Global Distribution.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1866-2021 | Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.; GTIN Primary Package: 40884522012981 GTIN Secondary Package: 30884522012984 Lot Numbers: 20G1304FAX 20G1305FAX 20L0026FAX 20L0027FAX 20L0410FAX 20L0411FAX 20L0412FAX | 32625 |
| Z-1867-2021 | Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.; GTIN Primary Package: 20884522033234 GTIN Secondary Package: 10884522033237 Lot Number: 20J0699FAX | 7200 |
| Z-1868-2021 | Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.; GTIN Primary Package: 10884521077409 GTIN Secondary Package: 20884521077406 Lot Numbers: 20C1164FAX 20C1165FAX 20C1166FAX 20C1235FAX 20C1236FAX 20D1187FAX 20D1188FAX 20D1189FAX 20D1190FAX 20D1191FAX 20D1429FAX 20D1430FAX 20D1432FAX 20D1433FAX 20D1523FAX 20D1524FAX 20D1525FAX 20D1526FAX 20D1527FAX 20D1528FAX 20E0158FAX 20E0159FAX 20E0160FAX 20E0161FAX 20E0162FAX 20E0163FAX 20E0164FAX 20E0165FAX 20E0390FAX 20E0391FAX 20E0392FAX 20E0393FAX 20E0871FAX 20E0873FAX 20E0874FAX 20E0875FAX 20E0935FAX 20E0936FAX 20E0997FAX 20E0998FAX | 192000 |
| Z-1869-2021 | HME for Tracheostomized Patients, Item Code 353S13046 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.; GTIN Primary Package: 10884521779372 GTIN Secondary Package: 20884521779379 Lot Numbers: 19F0869FAX 19F0870FAX 20G1669FAX 20G1670FAX 20H0377FAX | 10890 |
What to do — step by step
Check Product Details
Look for the item code 352/5877Z and specific lot numbers listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 7 states.
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of DE, KY, NY, TX, VA, VT, and WA. Global Distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Delaware, Kentucky, New York, Texas, Vermont, Virginia, Washington.
Recall timeline
FDA published this recall 55 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-1868-2021 (April 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1868-2021 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.