FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: MEDLINE DENTAL PACK, REF DYNJ66983. Convenience kit used in medical procedures.
- Recall number
- Z-0164-2023
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- MEDLINE DENTAL PACK, REF DYNJ66983. Convenience kit used in medical procedures.
- Status
- Open, Classified
- Initiated
- 2022-09-30
- Posted
- 2022-11-01
- Terminated
- not on file
- Reason
- Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
- Root cause
- Under Investigation by firm
- Action
- Medline disseminated MEDICAL DEVICE RECALL notice by US mail on 09/30/2022, The notices explained the issue and requested the following: "REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers listed on the recall portal. Destroy affected product. 2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. The login for completing the response form is: Website link: https://recalls.medline.com Recall Reference #: R-22-149-FG Recall Code: RXXXXXXX 3.Upon completion of the form, please destroy affected product. Your account will receive credit once the response form is submitted. 4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Have the customers document and destroy any affected product. You should include your customers quantities on your response form. If you have any questions, please contact the Recall Department at 866-359-1704."
- Quantity
- 60 units
- Distribution
- US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.
- Lot, serial or model codes
- GTIN (01) 40193489385404, Lot Number 22DBE139
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- 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