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U.S. Department of Health and Human Services

Class 2 Device Recall Hillrom WELCH ALLYN

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 Class 2 Device Recall Hillrom WELCH ALLYNsee related information
Date Initiated by FirmMay 09, 2025
Date PostedJune 11, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1962-2025
Recall Event ID 96825
Product Classification Otoscope - Product Code ERA
Product2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600
Code Information UDI/DI 00732094139488, Lot Number 25-043, Exp. August 2027
FEI Number 1417572
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information ContactCenter for One Baxter
800-422-9837
Manufacturer 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 Determined
Cause 2		Under Investigation by firm
ActionBaxter 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 Commerce277 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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