- Recalling firm
- Erbe USA Inc
- Reason for recall
- Probes may rupture/burst during activation
- Affected products (lot / model / serial)
- UDI: 04050147021846/ Expanded Lots:WO472498 WO472499 WO472615 WO472616 WO473794 WO473795 WO474908 WO474909 WO474910 WO475357 WO475358 WO477030 WO477513 WO477514 WO478643 WO478646 WO478647 WO478648 WO478843 WO478844;Initial Lots: WO461840 WO461846 WO462097 W2462284 WO463327 WO463328 WO463388 W2463594 WO464285 WO464286 WO465063 WO465064 W4465351 W2465601 W2465689 W2465749 W2465769 WO467873 WO467874 WO467875 WO468648 WO468649 WO469364 W2459861 W2459862 W2459863
- Units affected
- 3603 units
- Distribution pattern
- US Nationwide distribution, including Puerto Rico.
- Firm location
- Marietta, GA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- E-Mail
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1568-2026
- Recall initiated
- February 12, 2026
- FDA classification date
- March 20, 2026
- FDA report date
- April 1, 2026
- FDA event ID
- 98429
- Last updated on HTM Vibe
- July 24, 2026