Recall Z-1962-2025 ยท ERA Otoscope
Baxter Healthcare Corporation
2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600
| Date | Jun 11, 2025 (initiated May 9, 2025) |
| Status | Open, Classified |
| Reason | The replacement rechargeable batteries inserted into the Welch Allyn PocketScope handles have the potential to cause a short circuit in the handle, which can lead to exposure to excessive heat and user burns. |
| Root cause | Under Investigation by firm |
| Action | Baxter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 05/09/2025 via USPS First Class mail. The notice explained the issue, hazard involved, and requested to cease all use of the device and return it to Baxter. Please contact Baxter Technical Support to arrange for return and replacement of your affected battery or Welch Allyn PocketScope handle at 800-535-6663 between the hours of 8:00 am and 8:00 pm Eastern Time, Monday through Friday. Press option 2, then select option 1 or 2 for language preference, then press option 1 for physical exam, and then press 3 for physical |
| Quantity | 277 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.