FDA Medical Device Recalls (openFDA)
MEDLINE IND: Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. Single use only. Sterile if unopened, undamaged package.
- Recall number
- Z-0984-2017
- Recalling firm
- MEDLINE IND
- Product
- Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. Single use only. Sterile if unopened, undamaged package.
- Status
- Terminated
- Initiated
- 2016-12-12
- Posted
- not on file
- Terminated
- 2019-06-27
- Reason
- Product was not sterilized. Product was shipped to distribution centers instead of the sterilization facility due to an operations error by a 3rd party shipping company.
- Root cause
- Process control
- Action
- Medline Industries sent a recall notification letters dated December 12, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to quarantine any affected product on hand and return product to Medline Industries for credit. Distributors were instructed to notify their customers and have them return affected product as well. For questions contact 866-359-1704.
- Quantity
- 12,024 tubes
- Distribution
- Worldwide Distribution - US Nationwide in the states of AL, FL, GA, IA, IL, IN LA, MI, PA, TX, WI, and the country of Canada
- Lot, serial or model codes
- Lot Numbers: 6I26; Unit No: MDS032285; Expiration Date: 08/2019
- 510(k) numbers
- ["K041060"]
- PMA numbers
- not on file
- Product code
- KMJ
- 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