FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile surgical drape.
- Recall number
- Z-1370-2025
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile surgical drape.
- Status
- Open, Classified
- Initiated
- 2025-02-13
- Posted
- 2025-03-14
- Terminated
- not on file
- Reason
- Potential breach in pouch packaging which could lead to loss of sterility.
- Root cause
- Packaging process control
- Action
- Medline distributed an IMMEDIATE ACTION REQUIRED MEDICAL DEVICE RECALL notification, dated 2/13/25, to consignees who purchased individually packaged Proxima sterile surgical drapes and kits that contained Proxima sterile surgical drapes. Consignees that purchased kits containing recalled product are to immediately check stock for affected kits and place them in quarantine. Consignees are to complete the provided response form to receive over-labels to be applied to quarantined kits with additional instructions to remove the affected components prior to use of the kit. Consignees that purchased individual units of Proxima sterile surgical drapes are to immediately check stock for affected devices and immediately destroy identified product. Consignees are to complete the provided response form to obtain credit for the destroyed product. If a consignee is a distributor or have further distributed affected devices, they are instructed to forward the provided recall notification. Questions about this recall can be directed to Medline via phone at 866-359-1704 or by email to recalls@medline.com.
- Quantity
- 1,118 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Item No. CDS985210G, CDS985210G, CDS985210G, DYNJ65826A, DYNJ65826A, DYNJ65826A, DYNJ65826A, DYNJ87398, DYNJ87398, DYNJ908743C, DYNJ908743C, DYNJ908743C, DYNJ908743C, DYNJ908744C, DYNJ908744C, DYNJ908744C, DYNJ910326B; UDI (case): 40195327553310, 40195327516193, 40198459034405, 40195327636297, 40195327636280, 40198459075002; UDI (each): 10195327553319, 10195327516192, 10198459034404, 10195327636296, 10195327636289, 10198459075001; Lot No. (Shelf Life) 24LBK011(04/30/2026), 24JBR548(02/28/2026), 24IBN166(02/28/2026), 24KMF425(06/30/2026), 24JMI243(06/30/2026), 24IMI316(05/31/2026), 24HMH127(04/30/2026), 24JBW476(02/28/2026), 24HBK163(02/28/2026), 24KBA490(02/28/2026), 24JBM980(02/28/2026), 24JBB973(02/28/2026), 24IBQ750(03/31/2026), 24JBM981(02/28/2026), 24JBH713(02/28/2026), 24HBJ792(02/28/2026), 24KBQ357(12/31/2025).
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OJH
- 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