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FDA Medical Device Recalls (openFDA)

Baxter Healthcare Corporation: 2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600

Recall number
Z-1962-2025
Recalling firm
Baxter Healthcare Corporation
Product
2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600
Status
Open, Classified
Initiated
2025-05-09
Posted
2025-06-11
Terminated
not on file
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 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
277 units
Distribution
US Nationwide distribution.
Lot, serial or model codes
UDI/DI 00732094139488, Lot Number 25-043, Exp. August 2027
510(k) numbers
not on file
PMA numbers
not on file
Product code
ERA
Firm FEI
1417572
Firm city
Deerfield
Firm state
IL
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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