FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ909098
- Recall number
- Z-1393-2025
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ909098
- Status
- Open, Classified
- Initiated
- 2025-02-11
- Posted
- 2025-03-18
- Terminated
- not on file
- Reason
- Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
- Root cause
- Under Investigation by firm
- Action
- Medline Industries LP issued a recall notice to its consignees on 02/11/2025 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request the the syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. This is an expansion of 94581
- Quantity
- 456 kits
- Distribution
- Worldwide - US Nationwide and the country of Canada.
- Lot, serial or model codes
- 1) 10195327273132 (each) 40195327273133 (case), Lot Number 23GBK039Z
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OHM
- 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