CLASS II ONGOING Device recall · Reported 23 Jun 2021 · FDA Enforcement Report

Mechanical Filter with Connector Small, Tethered Cap recalled

Covidien is recalling Mechanical Filter with Connector Small, Tethered Cap, distributed nationwide in the US. The recall was initiated on 29 Apr 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN Primary Package: 20884522033234 GTIN Secondary Package: 10884522033237 Lot Number: 20J0699FAX

Quantity recalled7200

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-1867-2021
FDA event ID: 87925
Recalling firm: Covidien, North Haven, CT
Classification: Class II
Status: Ongoing
Recall initiated: 29 Apr 2021
FDA classified: 16 Jun 2021
Reported: 23 Jun 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: CPAP & Ventilators

Timeline

29 Apr 2021	Recall initiated by company
16 Jun 2021	Classified by FDA	+48 days
23 Jun 2021	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for 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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

Worldwide distribution - US Nationwide distribution in the states of DE, KY, NY, TX, VA, VT, and WA. Global Distribution.

Nationwide Kentucky New York Texas Virginia Vermont Washington

Questions about this recall

Is Mechanical Filter with Connector Small, Tethered Cap recalled?

Yes. Covidien recalled Mechanical Filter with Connector Small, Tethered Cap on 29 Apr 2021. The recall is Class II and its status is Ongoing. Recall number Z-1867-2021.

Why was it recalled?

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.

Which lots are affected?

GTIN Primary Package: 20884522033234 GTIN Secondary Package: 10884522033237 Lot Number: 20J0699FAX

Where was it sold?

Worldwide distribution - US Nationwide distribution in the states of DE, KY, NY, TX, VA, VT, and WA. Global 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.

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