—#212759

Product

Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL

FDA product code: NHB — Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Device class: Class 2
Medical specialty: Ear, Nose, Throat
510(k) numbers: K070715
Affected lot / code info: 5400-010-000 UDI-DI: 07613327301663, Lot Numbers:2023011112, 2023020334, 2023072413, 2024032615; 5400-010-000ITL UDI-DI: 07613327359510, Lot Numbers: 2023022132 2023112213 2024020515 2024032013

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

An Urgent Medical Device Recall notification letter dated 2/24/25 was sent to customers. Actions to be taken 1. Immediately review your inventory to locate and quarantine any affected products at your facility. 2. Return the enclosed Business Reply Form (BRF), even if the affected product is no longer in inventory, to the email Instruments.Recalls@stryker.com. 3. Upon receipt of the completed BRF, Stryker will provide a shipping label to return recalled product on-hand. 4. A replacement will be provided upon receipt of the recalled product. 5. Maintain awareness of this communication internally and inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients accordingly. Instruments.recalls@stryker.com. RESPONSE IS REQUIRED.

Recalling firm

Firm: Stryker Corporation
Address: 1941 Stryker Way, Portage, Michigan 49002-9711

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2025-02-25
Posted by FDA: 2025-03-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #212759. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.