Recall Z-1472-2025

Stryker Corporation · initiated February 25, 2025

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL

Codes / lots: 5400-020-000 UDI-DI: 07613327301670, 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; 5400-020-000ITL UDI-DI: 07613327359466, 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…

Reason for recall

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-determined cause: Under Investigation by firm

Action taken

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.

Details

Recall number
Z-1472-2025
Initiated
February 25, 2025
Posted by FDA
March 28, 2025
Product code
NHB – Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Quantity
182,344 total units
Distribution
US Nationwide distribution.
Recalling firm
Stryker Corporation, Portage, MI

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1469-2025 Class IIOtopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and…There is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… 02/25/2025Open, Classified
Z-1470-2025 Class IINasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and…There is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… 02/25/2025Open, Classified
Z-1471-2025 Class IINasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and…There is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… 02/25/2025Open, Classified
Z-1473-2025 Class IINasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte…There is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… 02/25/2025Open, Classified
Z-1474-2025 Class IINasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte…There is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… 02/25/2025Open, Classified
Z-1475-2025 Class IIOtopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte…There is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… 02/25/2025Open, Classified
Z-1476-2025 Class IINasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITLThere is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… 02/25/2025Open, Classified
Z-1477-2025 Class IIHemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and…There is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… 02/25/2025Open, Classified
Z-1478-2025 Class IINasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and…There is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… 02/25/2025Open, Classified
Z-1479-2025 Class IINasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and…There is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… 02/25/2025Open, Classified
Z-1480-2025 Class IINasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and…There is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… 02/25/2025Open, Classified
Z-1481-2025 Class IINasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and…There is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… 02/25/2025Open, Classified
Z-1482-2025 Class IIHemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208SThere is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… 02/25/2025Open, Classified