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FDA Medical Device Recalls (openFDA)

Scrip Inc: Scrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultrasound transducer to tissue

Recall number
Z-0224-2022
Recalling firm
Scrip Inc
Product
Scrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultrasound transducer to tissue
Status
Open, Classified
Initiated
2021-08-18
Posted
not on file
Terminated
not on file
Reason
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
Root cause
Process control
Action
The recalling firm, allegromedical, issued "URGENT Action Required" correspondence on or around 10/12/2021 informing customers of the recall and to stop use of the product. If product was further distributed, customers are asked to notify additional recipients of the product recall. If you have any questions, contact VP of Operation at 630-771-7410 or email: lpantera@scripco.com.
Quantity
1001 gallons
Distribution
US Nationwide Distribution to all 50 states.
Lot, serial or model codes
Item Number: 663 0061, all lots bearing old style logo. Older logo states that product was manufactured by Eco-Med Pharmaceuticals in Canada.
510(k) numbers
["K955246"]
PMA numbers
not on file
Product code
ITX
Firm FEI
1457081
Firm city
Peoria
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

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

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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