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FDA Medical Device Recalls (openFDA)

Medline Industries Inc: Medline DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made in Malaysia APPLICATOR:Made in China STERILE (01)40889942587583(10)0000000000 (17)000000(30)20 Packaged for Medline Industries, Inc., Northfield, IL 60093 USA. 1-800-MEDLINE www.medline.com WINGED SPONGE:Made in Mexico

Recall number
Z-0865-2020
Recalling firm
Medline Industries Inc
Product
Medline DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made in Malaysia APPLICATOR:Made in China STERILE (01)40889942587583(10)0000000000 (17)000000(30)20 Packaged for Medline Industries, Inc., Northfield, IL 60093 USA. 1-800-MEDLINE www.medline.com WINGED SPONGE:Made in Mexico
Status
Terminated
Initiated
2020-01-07
Posted
not on file
Terminated
2020-09-16
Reason
There is potential for the sterile wrap to become loose while in transit and compromise the sterile barrier.
Root cause
Packaging
Action
Consignees notified by first class mail with formal recall letter dated January 07, 2020. The letter identified affected product, stated reason for recall, and requested product to be quarantined. A response form was requested to be returned via email.
Quantity
500
Distribution
Kentucky. No governmental, Canadian, or Mexican consignees.
Lot, serial or model codes
Code DYNDA1928 Lot Number: 2019032190 Expiration Date 07/31/2020
510(k) numbers
not on file
PMA numbers
not on file
Product code
LRP
Firm FEI
1417592
Firm city
Northfield
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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