⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Philips Ultrasound, Inc: Philips OMNI III TEE Ultrasound Transducer

Medical DevicesSource: FDA (device) · Date: 2026-04-01

Read the official notice at FDA (device) →

Share on XFacebookRedditEmail

Get alerts for Philips Ultrasound

Guides: Which agency handles which recall (FDA vs USDA vs CPSC vs NHTSA)

The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Philips Ultrasound, Inc
Product
Philips OMNI III TEE Ultrasound Transducer
Reason / hazard
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Classification
Class III
Status
Ongoing
Distribution / sold at
US Nationwide distribution.
Recall initiated
2025-09-05
Code info
Model No. 989605440701, 989605440702, 989605440772, 989803001561; UDI: (01)00884838067585(21)02ZTTT, (01)00884838067585(21)B0X7MD, (01)00884838067585(21)02VWNV, (01)00884838067585(21)02JQPG, (01)00884838067585(21)02PCMT, (01)00884838067585(21)0341PG, (01)00884838067585(21)02QLMQ, (01)00884838067585(21)B0JFCN, (01)00884838067585(21)03C009, (01)00884838067585(21)02Y7HM, (01)00884838067585(21)02VTGK, (01)00884838067585(21)037CHG, (01)00884838067585(21)03G0BB, (01)00884838067585(21)02WH6F, (01)00884838067585(21)02QK2L, (01)00884838067585(21)037F68, (01)00884838067585(21)0344C9, (01)00884838067585(21)037HLM, (01)00884838067646(21)035R8K, (01)00884838067585(21)02JJ0T, (01)00884838067585(21)031LC8, (01)00884838067585(21)039JWQ, (01)00884838067585(21)03436F, (01)00884838067585(21)039PCB, (01)00884838067585(21)02P8GV, (01)00884838067585(21)B07FFB, (01)00884838067585(21)03F770, (01)00884838067585(21)0319LX, (01)00884838067585(21)02DG0D, (01)00884838067585(21)B0JF93, (01)00884838067585(21)03C7Q0, (01)00884838067585(21)039Q2L, (01)00884838067585(21)02YCFD, (01)00884838067585(21)B05DX2, (01)00884838067585(21)02WCTB, (01)00884838067585(21)039PC3, (01)00884838067585(21)035V3H, (01)00884838067585(21)038DX2, (01)00884838067585(21)B0LYR8, (01)00884838067585(21)02CGWH, (01)00884838067585(21)032MLN, (01)00884838067585(21)038LT2, (01)00884838067585(21)03G4GG, (01)00884838067585(21)03435X, (01)00884838067585(21)032MMK, (01)00884838067585(21)B0JFDK, (01)00884838067585(21)02WMD4, (01)00884838067585(21)02JP4Z, (01)00884838067585(21)031LCH, (01)00884838067585(21)02JJ6T, (01)00884838067585(21)039JWV, (01)00884838067585(21)035YQG, (01)00884838067585(21)03C04R, (01)00884838067585(21)02DCH7, (01)00884838067585(21)02D9TH, (01)00884838067585(21)035Q9M, (01)00884838067585(21)031CDK, (01)00884838067585(21)0379BH; Serial No. 02ZTTT, 02DFBP, B0X7MD, 039MMD, 02VWNV, 02JQPG, 02PCMT, 0341PG, 02GR5B, 035PWZ, 02QLMQ, B0JFCN, 03CVTB, 03C009, 02Y7HM, 02VTGK, 037CHG, 03G0BB, 02WH6F, 02QK2L, 038MJ6, 037F68, 038GL7, 0344C9, 037HLM, 035R8K, 02JL01, 02JJ0T, 031LC8, 039JWQ, 035PYK, 03436F, 039PCB, 031HN7, 02P8GV, 039HQ2, B07FFB, 03F770, 035Q9P, 0319LX, 02DG0D, B0JF93, 03C7Q0, 039Q2L, 02YCFD, B05DX2, 02WCTB, 039PC3, 035V3H, 038DX2, B0LYR8, 02CGWH, 032MLN, 035P8R, 038LT2, 03G4GG, 03435X, 032MMK, 02QGKV, B0JFDK, 02VN40, 032FKW, 02WMD4, 02JP4Z, 031LCH, 02JJ6T, 039JWV, 035YQG, 03C04R, 03C6ZH, 02DCH7, 02D9TH, 035Q9M, 031CDK, 0379BH.
Product quantity
75 units
Voluntary mandated
Voluntary: Firm initiated
City
Reedsville
State
PA
Country
United States
Event id
97643
Free daily digest + "My products" watchlist

Get the daily digest, and tell us what to watch. Everything is optional except your email.

Free allergen alerts:

Categories:

Privacy: we store only what you enter here, use it only to send recall alerts you asked for, never sell or share it, and you can unsubscribe anytime. Double opt-in: we will email you a confirmation link before sending anything; alerts start only after you confirm. Every email has unsubscribe and manage-watchlist links.