Hemopore 8cm nasal/sinus temporary wound dressing
Medical device recall Z-1477-2025. 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?
Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)
182,344 total units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
5400-020-208 UDI-DI: 07613327117233, Lot Numbers: 2022093020 2023011632 2023041321 2023062320 2023092220 2023112232 2024032120 2024052420 2022093021 2023011932 2023042120 2023062220 2023092932 2023112420 2024032820 2024052320 2022100720…
Every code shown here, 1,381 characters
5400-020-208 UDI-DI: 07613327117233, Lot Numbers: 2022093020 2023011632 2023041321 2023062320 2023092220 2023112232 2024032120 2024052420 2022093021 2023011932 2023042120 2023062220 2023092932 2023112420 2024032820 2024052320 2022100720 2023012732 2023042121 2023073120 2023101220 2023112320 2024032920 2024060620 2022100620 2023013033 2023050320 2023073121 2023101221 2023120120 2024040520 2024060720 2022101320 2023020132 2023050220 2023081520 2023101921 2023113020 2024040420 2024062020 2022101420 2023020632 2023051620 2023081521 2023101920 2023120632 2024041820 2024062120 2022101720 2023022033 2023051720 2023082520 2023102721 2023121533 2024041920 2024070420 2022102120 2023030220 2023052620 2023082521 2023102720 2024010532 2024042632 2024070520 2022102720 2023030320 2023052520 2023083120 2023110320 2024020120 2024042520 2024071538 2022102820 2023032420 2023060120 2023090120 2023110220 2024020220 2024042620 2024071738 2022110220 2023032320 2023060220 2023090820 2023110733 2024030820 2024050821 2022110320 2023032920 2023060820 2023090620 2023110920 2024030720 2024050820 2022112932 2023033020 2023060920 2023091520 2023110921 2024031420 2024051520 2023010433 2023040732 2023061520 2023091420 2023111720 2024031520 2024051721 2023010932 2023041320 2023061620 2023092120 2023111620 2024032220 2024052332 7; 5400-020-208ITL UDI-DI: 07613327602623, Lot Numbers: 2024052333
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.”
- 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
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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.