Z-1962-2025Class II

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

Name: Z-1962-2025 2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600
Creator: Baxter Healthcare Corporation
Published: 2025-05-09
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2025-05-09 / Open, Classified

FDA source

Baxter Healthcare Corporation began a recall of 2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600 on 2025-05-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1962-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-09
Posted: 2025-06-11
Recalling firm: Baxter Healthcare Corporation
Product: 2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600
Product code: ERA Otoscope
Reason for recall: 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.
FDA 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 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.
Quantity in commerce: 277 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI/DI 00732094139488, Lot Number 25-043, Exp. August 2027

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1962-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1962-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-11

Product code ERA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)