FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: Medline medical procedure kits labeled as follows: a) MAJOR BREAST, REF DYNJ905004C; b) MINOR BREAST, REF DYNJ905002B; c) SUCTION MEDI VAC, REF DYKM2033
- Recall number
- Z-2707-2024
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline medical procedure kits labeled as follows: a) MAJOR BREAST, REF DYNJ905004C; b) MINOR BREAST, REF DYNJ905002B; c) SUCTION MEDI VAC, REF DYKM2033
- 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
- 3539 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 DYNJ905004C, UDI/DI 40195327316939 (case), 10195327316938 (unit), Lot Numbers: 23CBG213, 23EBI690, 23FBT057, 23GBB635, 23IBA478, 23JBB064; b) REF DYNJ905002B, UDI/DI 40195327316861 (case), 10195327316860 (unit), Lot Numbers: 23ABK521, 23BBG561, 23CBU161, 23EBE334; c) REF DYKM2033, UDI/DI 40193489849241 (case), 10193489849240 (unit), Lot Numbers: 22FMF595, 22HMB247, 22HMD137, 22LMD691, 22LMH566, 23BMG473, 23DMI525, 23FMG464, 23GMH062, 23IMH701, 23KMA183
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FTN
- 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