FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: Medline convenience kits containing semi-rigid suction liners labeled as follows: a) AMB VITRECTOMY, Pack Number DYNJ59921B; b) AMB VITRECTOMY, Pack Number DYNJ59921BH; c) AMB OCULOPLASTICS MUSC, Pack Number DYNJ59923B; d) AMB OCULOPLASTICS MUSC, Pack Number DYNJ59923BH; e) AMB CUSTOM EYE, Pack Number DYNJ59924B; f) AMB CUSTOM EYE, Pack Number DYNJ59924BH; g) CATARACT-30843, Pack Number DYNJVB91139
- Recall number
- Z-3120-2024
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline convenience kits containing semi-rigid suction liners labeled as follows: a) AMB VITRECTOMY, Pack Number DYNJ59921B; b) AMB VITRECTOMY, Pack Number DYNJ59921BH; c) AMB OCULOPLASTICS MUSC, Pack Number DYNJ59923B; d) AMB OCULOPLASTICS MUSC, Pack Number DYNJ59923BH; e) AMB CUSTOM EYE, Pack Number DYNJ59924B; f) AMB CUSTOM EYE, Pack Number DYNJ59924BH; g) CATARACT-30843, Pack Number DYNJVB91139
- Status
- Open, Classified
- Initiated
- 2024-06-27
- Posted
- 2024-09-11
- Terminated
- not on file
- Reason
- XXX
- Root cause
- Process control
- Action
- Medline Industries issued a MEDICAL DEVICE RECALL notice to its consignees on 06/27/2024 via US mail and email. The notice explained the problem with the device, potential risk to the patient, and requested the consignee immediately check their stock for the affected item number and the affected lot numbers and destroy any affected inventory. Distributors were directed to notify their customers of the recall and request the affected products be destroyed. For questions: contact the Recall Department at 866-359-1704 or recalls@medline.com.
- Quantity
- 720 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Panama.
- Lot, serial or model codes
- a) DYNJ59921B: UDI/DI case 40195327037148, UDI/DI each 10195327037147, Lot Numbers: 23LBS025, 24ABY181; b) DYNJ59921BH: UDI/DI case 40195327037148, UDI/DI each 10195327037147, Lot Numbers: 23LBS025, 24ABY181; c) DYNJ59923B: UDI/DI case 40195327043217, UDI/DI each 10195327043216, Lot Numbers: 23LBF664, 23LBS053, 24ABY182; d) DYNJ59923BH: UDI/DI case 40195327043217, UDI/DI each 10195327043216, Lot Numbers: 23LBF664, 23LBS053, 24ABY182; e) DYNJ59924B: UDI/DI case 40195327036967, UDI/DI each 10195327036966, Lot Numbers: 23LBD909; f) DYNJ59924BH: UDI/DI case 40195327036967, UDI/DI each 10195327036966, Lot Numbers: 23LBD909; g) DYNJVB91139: UDI/DI case 40195327607105, UDI/DI each 10195327607104, Lot Numbers: 24CLA670, 24CLA895
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OJK
- 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