FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF DYNJ902752C, b) KIT ENDO, REF DYKE1872A, c) LOWER ENDO KIT, REF DYKE1921A, d) PACEMAKER, REF DYNJ901681D, e) UPPER ENDO KIT, REF DYKE1922A, f) VASCULAR, REF DYNJ905515D, g) VASCUALR, REF DYNJ902387K, h) VASCULAR III, REF DYNJS2035C
- Recall number
- Z-2701-2024
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF DYNJ902752C, b) KIT ENDO, REF DYKE1872A, c) LOWER ENDO KIT, REF DYKE1921A, d) PACEMAKER, REF DYNJ901681D, e) UPPER ENDO KIT, REF DYKE1922A, f) VASCULAR, REF DYNJ905515D, g) VASCUALR, REF DYNJ902387K, h) VASCULAR III, REF DYNJS2035C
- Status
- Open, Classified
- Initiated
- 2024-03-22
- Posted
- 2024-08-22
- Terminated
- not on file
- Reason
- A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- Root cause
- Under Investigation by firm
- Action
- Medline Industries issued a Safety Alert to its consignees on 03/22/2024 via email and certified mail. The notice explained the problem with the device and requested that consignees follow the instructions for use. Distributors or those who further transferred the affected product were directed to notify their consignees.
- Quantity
- 26096 units
- Distribution
- Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.
- Lot, serial or model codes
- a) REF DYNJ902752C, UDI/DI 40195327226993 (case), 10195327226992 (unit), Lot Numbers: 22IBA627, 22JBE922, 22JBP917, 22KBJ447, 23BBB611, 23CBC455, 23EBF908, 23FBV764, 23GBW761, 23IBR157; b) REF DYKE1872A, UDI/DI 40195327330027 (case), 10195327330026 (unit), Lot Numbers: 23CBB846, 23CBK197, 23DBK952, 23FBD020, 23FBG375, 23FBJ258, 23FBV848, 23HBA337, 23HBC022, 23IBA872, 23IBL364, 23JBB228, 23JBE437, 23JBE720, 23JBF969, 23JBV002, 23JBV507, 23KBG556, 23KBM618; c) REF DYKE1921A, UDI/DI 40195327488612 (case), 10195327488611 (unit), Lot Numbers: 23HBQ471, 23JBK197, 23LBD048; d) REF DYNJ901681D, UDI/DI 40193489308090 (case), 10193489308099 (unit), Lot Numbers: 22EBC373, 22EBD234, 22EBE775, 22EBF837, 22FBV877, 22GBT729, 23ABA707, 23BBI384, 23FBO404, 23GBO428, 23GBO470, 23JBH973; e) REF DYKE1922A, UDI/DI 40195327487943 (case), 10195327487942 (unit), Lot Numbers: 23IBK378, 23IBM326, 23JBP210, 23KBX462; f) REF DYNJ905515D, UDI/DI 40193489968041 (case), 10193489968040 (unit), Lot Numbers: 22FMB396, 22FMG767, 22IMB116, 22LMA842, 23AMI823, 23GMH322, 23IMC097; g) REF DYNJ902387K, UDI/DI 40195327505852 (case), 10195327505851 (unit), Lot Numbers: 23JBR461, 23KBT452; h) REF DYNJS2035C, UDI/DI 40193489214278 (case), 10193489214277 (unit), Lot Numbers: 22FDA441, 22GDA574, 22JDB543, 22LDB596, 23ADB285
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OEZ
- 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