Device recall: Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL
Class II FDA enforcement event 96393. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
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
Stryker Corporation started this device recall on 25 Feb 2025. The firm address in the FDA record is in Portage, MI. FDA put the recall in Class II. FDA event 96393 has 14 product records. The first FDA enforcement report date is 9 Apr 2025. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide distribution.
Recalling firm
Stryker Corporation, Portage, MI.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
14 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1469-2025 | Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL | 182,344 total units | Class II | Ongoing | 9 Apr 2025 |
| Z-1470-2025 | Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL | 182,344 total units | Class II | Ongoing | 9 Apr 2025 |
| Z-1471-2025 | Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL | 182,344 total units | Class II | Ongoing | 9 Apr 2025 |
| Z-1472-2025 | Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL | 182,344 total units | Class II | Ongoing | 9 Apr 2025 |
| Z-1473-2025 | Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITL | 182,344 total units | Class II | Ongoing | 9 Apr 2025 |
| Z-1474-2025 | Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITL | Class II | Ongoing | 9 Apr 2025 | |
| Z-1475-2025 | Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL | 182,344 total units | Class II | Ongoing | 9 Apr 2025 |
| Z-1476-2025 | Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL | 182,344 total units | Class II | Ongoing | 9 Apr 2025 |
| Z-1477-2025 | Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS) | 182,344 total units | Class II | Ongoing | 9 Apr 2025 |
| Z-1478-2025 | Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Catalog Number 5400-030-004ITL | 182,344 total units | Class II | Ongoing | 9 Apr 2025 |
| Z-1479-2025 | Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plus 8cm Catalog Number 5400-030-008ITL | 182,344 total units | Class II | Ongoing | 9 Apr 2025 |
| Z-1480-2025 | Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S | 182,344 total units | Class II | Ongoing | 9 Apr 2025 |
| Z-1481-2025 | Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S | 182,344 total units | Class II | Ongoing | 9 Apr 2025 |
| Z-1482-2025 | Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S | 182,344 total units | Class II | Ongoing | 9 Apr 2025 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2025
- 945
- Share of these events in Class II
- 85%
- Product records in this event
- 14Median of the firm: 2
- Events of the firm on the register
- 37
Other events of the firm
Official channels
- FDA enforcement report Z-1469-2025The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 96393. https://recallregister.com/fda/ii/96393/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide distribution.
- What quantity of product is in FDA event 96393?
- The event has 14 product records. The first record gives this quantity:
182,344 total units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2025 have the same class?
- 85% of the 945 device events that started in 2025 are in Class II.