Nasopore 8cm fragmentable nasal dressing, Firm
Medical device recall Z-1473-2025. Published in FDA’s Enforcement Report on Apr 9, 2025.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 9, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 182,344 total units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITL
182,344 total units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
5400-020-008 UDI-DI: 07613154340828, Lot Numbers:2022101214 2023011115 2023021612 2023061932 2023101632 2024011532 2024051512 2022101314 2023011212 2023031312 2023062612 2023110232 2024021914 2024072631 2022101414 2023011314 2023031414…
Every code shown here, 1,996 characters
5400-020-008 UDI-DI: 07613154340828, Lot Numbers:2022101214 2023011115 2023021612 2023061932 2023101632 2024011532 2024051512 2022101314 2023011212 2023031312 2023062612 2023110232 2024021914 2024072631 2022101414 2023011314 2023031414 2023062812 2023113034 2024022731 2024081312 2022101914 2023011615 2023042413 2023072433 2023120732 2024030431 2024082614 2023010912 2023011814 2023050212 2023091112 2023121532 2024031932 2024082812 2022101214 2023011115 2023021612 2023061932 2023101632 2024011532 2024051512 2023011015 2023021313 2023051014 2023091212 2023121832 2024050814 ; 5400-020-008ITL UDI-DI: 07613327359428, Lot Numbers: 2022101912 2023030914 2023070715 2023073132 2023090512 2023101012 2023110832 2023120612 2022102614 2023031015 2023070712 2023080132 2023090712 2023101014 2023111314 2023120633 2022110714 2023032932 2023071132 2023080232 2023090814 2023101133 2023110932 2023120714 2022110814 2023042614 2023071133 2023080233 2023091214 2023101114 2023111332 2023120712 2022110914 2023050113 2023071134 2023080332 2023091314 2023101314 2023111333 2023120814 2022111014 2023050312 2023071135 2023080732 2023091416 2023101313 2023111514 2023120812 2022111114 2023050412 2023071232 2023080733 2023091514 2023101615 2023111632 2023121232 2022111715 2023061414 2023071233 2023080932 2023091815 2023101612 2023112132 2023121233 2022111814 2023061933 2023071432 2023080833 2023091916 2023101832 2023112012 2023121333 2022113014 2023061913 2023071433 2023081132 2023092014 2023101814 2023112215 2023121332 2022120214 2023062114 2023071733 2023081432 2023092114 2023101812 2023112233 2023121833 2022120514 2023062712 2023071832 2023081412 2023092533 2023102012 2023112332 2023121932 2022120614 2023062912 2023071833 2023081713 2023092733 2023102314 2023112317 2024010232 2022120712 2023063012 2023071932 2023081532 2023100212 2023102412 2023112714 2024010333 2022120914 2023063014 2023072032 2023081632 2023100215 2023102614 2023113032 2024010332 2022121214 2023062932 2023072132 2023082112…
FDA’s list runs to 4,943 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Feb 25, 2025.
- FDA classified it on Mar 28, 2025.
- FDA’s Enforcement Report published it on Apr 9, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Stryker Corporation, of Portage, MI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 4,943 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.