- Recalling firm
- MICROVENTION INC.
- Reason for recall
- Due to an increase rate of balloon pinhole defects.
- Affected products (lot / model / serial)
- Catalog Number: BOB-895-CN UDI codes: (01)00842429111062(11)250819(17)280731(10)0001218734 (01)00842429111062(11)250822(17)280731(10)0001222844 (01)00842429111062(11)250825(17)280731(10)0001224137 (01)00842429111062(11)250828(17)280731(10)0001226522 (01)00842429111062(11)250910(17)280831(10)0001264372 (01)00842429111062(11)250911(17)280831(10)0001281308 (01)00842429111062(11)250917(17)280831(10)0001283704 Lot Numbers: 0001218734 0001222844 0001224137 0001226522 0001264372 0001281308 0001283704 Catalog Number: BOB-895-EMEA UDI code: (01)00842429108550(11)241108(17)271031(10)0000756596 (01)00842429108550(11)241109(17)271031(10)0000757384 (01)00842429108550(11)241118(17)271031(10)0000758945 (01)00842429108550(11)241120(17)271031(10)0000765270 (01)00842429108550(11)241121(17)271031(10)0000767660 (01)00842429108550(11)241126(17)271031(10)0000772588 (01)00842429108550(11)241202(17)271130(10)0000774885 (01)00842429108550(11)241128(17)271031(10)0000778089 (01)00842429108550(11)241204(17)271130(10)0000779647 (01)00842429108550(11)241207(17)271130(10)0000781240 (01)00842429108550(11)241210(17)271130(10)0000784041 (01)00842429108550(11)241210(17)271130(10)0000799436 (01)00842429108550(11)241213(17)271130(10)0000802183 (01)00842429108550(11)241210(17)271130(10)0000802619 (01)00842429108550(11)241214(17)271130(10)0000809792 (01)00842429108550(11)241217(17)271130(10)0000812812 (01)00842429108550(11)241217(17)271130(10)0000814498 (01)00842429108550(11)241220(17)271130(10)0000816560 (01)00842429108550(11)250108(17)271231(10)0000818876 (01)00842429108550(11)250110(17)271231(10)0000823404 (01)00842429108550(11)241217(17)271130(10)0000823532 (01)00842429108550(11)250113(17)271231(10)0000828250 (01)00842429108550(11)250115(17)271231(10)0000830529 (01)00842429108550(11)250118(17)271231(10)0000836906 (01)00842429108550(11)250118(17)271231(10)0000837785 (01)00842429108550(11)250118(17)271231(10)0000863256 (01)00842429108550(11)250123(17)271231(10)0000866698 (01)00842429108550(11)250124(17)271231(10)0000874138 (01)00842429108550(11)250125(17)271231(10)0000875976 (01)00842429108550(11)250129(17)271231(10)0000906381 (01)00842429108550(11)250131(17)271231(10)0000912667 (01)00842429108550(11)250204(17)280131(10)0000915955 (01)00842429108550(11)250203(17)280131(10)0000919813 (01)00842429108550(11)250205(17)280131(10)0000922930 (01)00842429108550(11)250206(17)280131(10)0000927345 (01)00842429108550(11)250207(17)280131(10)0000930383 (01)00842429108550(11)250212(17)280131(10)0000937458 (01)00842429108550(11)250210(17)280131(10)0000945855 (01)00842429108550(11)250220(17)280131(10)0000976589 Lot Numbers: 0000756596 0000784041 0000823532 0000912667 0000757384 0000799436 0000828250 0000915955 0000758945 0000802183 0000830529 0000919813 0000765270 0000802619 0000836906 0000922930 0000767660 0000809792 0000837785 0000927345 0000772588 0000812812 0000863256 0000930383 0000774885 0000814498 0000866698 0000937458 0000778089 0000816560 0000874138 0000945855 0000779647 0000818876 0000875976 0000976589 0000781240 0000823404 0000906381 Catalog Number: BOB-895-EMEA-AL UDI codes: (01)00842429118511(11)250213(17)280131(10)0000985070 (01)00842429118511(11)250217(17)280131(10)0000991168 (01)00842429118511(11)250219(17)280131(10)0000992810 (01)00842429118511(11)250222(17)280131(10)0000993790 (01)00842429118511(11)250225(17)280131(10)0000994829 (01)00842429118511(11)250228(17)280131(10)0000995565 (01)00842429118511(11)250303(17)280229(10)0000996450 (01)00842429118511(11)250305(17)280229(10)0001015817 (01)00842429118511(11)250307(17)280229(10)0001016002 (01)00842429118511(11)250310(17)280229(10)0001018992 (01)00842429118511(11)250321(17)280229(10)0001021878 (01)00842429118511(11)250311(17)280229(10)0001023107 (01)00842429118511(11)250313(17)280229(10)0001025449 (01)00842429118511(11)250319(17)280229(10)0001028255 (01)00842429118511(11)250324(17)280229(10)0001029974 (01)00842429118511(11)250327(17)280229(10)0001031633 (01)00842429118511(11)250415(17)280331(10)0001053417 (01)008
- Units affected
- 5500 devices
- Distribution pattern
- Worldwide - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IA, IL, KS, KY, LA, MI, MN, MO, MT, NC, NH, NM, NY, OH, PA, SD, TN, TX, WA, and WI. The countries of Europe - Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Lithuania, Netherlands, Norway, Poland, Romania, Slovenia, South Africa, Spain, Sweden, Switzerland, Ukraine, and United Kingdom. Asia - China, Japan, Jordan, New Zealand, South Korea, and United Arab Emirates.
- Firm location
- Aliso Viejo, CA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2912-2026
- Recall initiated
- April 30, 2026
- FDA classification date
- August 7, 2026
- FDA report date
- August 19, 2026
- FDA event ID
- 98909
- Last updated on HTM Vibe
- August 26, 2026