—#213730

Product

2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600

FDA product code: ERA — Otoscope
Device class: Class 1
Medical specialty: Ear, Nose, Throat
Affected lot / code info: UDI/DI 00732094139488, Lot Number 25-043, Exp. August 2027

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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 exam products. Forward a copy of the notice to any other departments with the institution that may use the affected product. Distributors were directed to notify their consignees.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2025-05-09
Posted by FDA: 2025-06-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #213730. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.