Stryker Corporation Recall 96393
Description: Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL
Stryker Corporation Recall 96393 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1472-2025 |
| Event ID | 96393 |
| Event Description | Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 182,344 total units |
| Recall Reason | 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. |
| Device Classification | 20250409 |
| Device Code Info | 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 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 2023100232 2023102532 2023113033 2024010432 2022121412 2023070312 2023072033 2023082116 2023100532 2023103015 2023113016 2024010433 2023013114 2023070432 2023072434 2023082212 2023100533 2023103012 2023120433 2024010832 2023020115 2023070412 2023072532 2023082415 2023100511 2023110132 2023120432 2024010833 2023020314 2023070414 2023072512 2023082914 2023100514 2023110332 2023120412 2024010812 2023020615 2023070512 2023072533 2023082912 2023100614 2023110216 2023120414 2024010932 2023021714 2023070514 2023072732 2023083014 2023100612 2023110632 2023120532 2024010933 2023030612 2023070612 2023072832 2023083114 2023101032 2023110833 2023120614 2024011014 2023030714 2023070614 2023070715 2023090414 2023101132 2023110815 2023110832 2024011032 2024011132 2024022012 2024032116 2024041715 2024051532 2024061012 2024070214 2024080712 2024011114 2024022115 2024032714 2024041732 2024051612 2024061112 2024070312 2024080714 2024011533 2024022214 2024032712 2024041816 2024051614 2024061132 2024070314 2024080814 2024011632 2024022632 2024032814 2024041814 2024051732 2024061232 2024070416 2024080812 2024011633 2024022314 2024032914 2024041831 2024051714 2024061315 2024070532 2024081314 2024011615 2024022612 2024040312 2024041914 2024052115 2024061312 2024070414 2024081414 2024011732 2024022831 2024040314 2024042215 2024052112 2024061412 2024070932 2024081512 2024011833 2024022614 2024040232 2024042414 2024052214 2024061414 2024070815 2024081412 2024011832 2024022931 2024040416 2024042516 2024052432 2024061812 2024070514 2024081514 2024012232 2024022933 2024040331 2024042614 2024052314 2024061912 2024071631 2024081914 2024012234 2024030114 2024040514 2024042912 2024052316 2024061914 2024071731 2024081912 2024012233 2024030531 2024040932 2024043012 2024052414 2024062016 2024071831 2024082114 2024011916 2024030631 2024040814 2024043015 2024052711 2024062014 2024071931 2024082315 2024012332 2024030514 2024040812 2024050112 2024052714 2024062114 2024072231 2024082712 2024012432 2024030731 2024041031 2024050114 2024052932 2024062415 2024072331 2024082715 2024012415 2024030814 2024041132 2024050214 2024052815 2024062514 2024072431 2024082814 2024012433 2024031132 2024041232 2024050212 2024053014 2024062732 2024072531 2024090232 2024012532 2024031114 2024041012 2024050314 2024053112 2024062614 2024071012 2024090332 2024012932 2024031332 2024040914 2024050312 2024053114 2024062612 2024072913 2024090331 2024012933 2024031315 2024040912 2024050613 2024060312 2024062714 2024071512 2024090432 2024012915 2024031432 2024041014 2024050615 2024060314 2024062712 2024071112 2024090431 2024020116 2024031416 2024041631 2024050712 2024060413 2024062812 2024073112 2024090532 2024020612 2024031832 2024041114 2024051432 2024060614 2024070332 2024080214 2024090932 2024021314 2024032032 2024041112 2024051415 2024060712 2024070432 2024080514 2024090931 2024021614 2024032015 2024041612 2024051516 2024051532 2024070212 2024080615 2024091034 |
| Center Classification Date | 20250328 |
| Recall Initiation Date | 20250225 |
| Recalling Firm | Stryker Corporation |
| Initial Notification | Letter |
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