FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M; 2) CRANI, REF DYNJ56001B; 3) GENDER AFFIRMING SURGERY, REF DYNJ66252; 4) GENDER AFFIRMING SURGERY, REF DYNJ66252A; 5) MAJOR NEURO PACK-LF, REF DYNJ0578916X.
- Recall number
- Z-0777-2025
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M; 2) CRANI, REF DYNJ56001B; 3) GENDER AFFIRMING SURGERY, REF DYNJ66252; 4) GENDER AFFIRMING SURGERY, REF DYNJ66252A; 5) MAJOR NEURO PACK-LF, REF DYNJ0578916X.
- Status
- Open, Classified
- Initiated
- 2024-11-21
- Posted
- 2024-12-30
- Terminated
- not on file
- Reason
- Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
- Root cause
- Nonconforming Material/Component
- Action
- Medline issued a MEDICAL DEVICE VOLUNTARY RECALL notice on 11/21/2024 to its consignees via US Mail and email. The notice explained the issue, potential risk to health, and requested that the affected product be quarantined. Once the response is received, Medline will provide labels to place on affected inventory, with instructions for the consignee to remove the affected component prior to using the kit.
- Quantity
- 1236 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of UAE, and Canada.
- Lot, serial or model codes
- 1) REF DYNJ0382559M, UDI/DI 10889942063994 (EA) 10889942063995 (CS), Lot Numbers: 19TBC792; 2) REF DYNJ56001B, UDI/DI 10889942798278 (EA) 40889942798279 (CS), Lot Numbers: 19BDC737, 19FDA310, 19FDB230, 19JDA441; 3) REF DYNJ66252, UDI/DI 10193489324785 (EA) 40193489324786 (CS), Lot numbers: 20DBK065, 20FBN251, 20HBL176, 20HBM692, 21CBP776; 4) REF DYNJ66252A, UDI/DI 10193489887853 (EA) 40193489887854 (CS), Lot numbers: 21IBN151, 21KBO915, 21LBJ105, 21VBB714; 5) REF DYNJ0578916X, UDI/DI 10193489288384 (EA) 40193489288385 (CS), Lot numbers: 22OBL262,20CKA219, 20CKA875, 20EKB076, 20GKA543, 20GKB272, 20IKB497, 20JKB716, 21AKA500, 21BKA195, 21FMD808, 21HMD657, 21IMB172, 21JMH627, 21KMH877, 21LMC161, 22AMA533, 22DMC612, 22DMI233, 22GMB685, 22IMA041, 23AMD730, 23DMA094, 23FMF542, 23IME618, 24AMA230.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OES
- 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