Medline Industries, Lp: General Purpose Dental Tray
Recall Summary Medline is recalling ORAL RESTORATION medical procedure kits (Kit Number DYNJ86253A) because samples failed to meet quality standards. The defects include surface irregularities on the catheter, premature detachment of the catheter connector, and some catheters that were the wrong diameter. These kits were distributed nationwide in the US and to multiple countries worldwide.
- Recalling firm
- Medline Industries, LP
- Product
- MEDLINE Medical Procedure Kits labeled as: ORAL RESTORATION, Medline Kit Number/SKUDYNJ86253A
- Reason
- During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-04
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/ea9f54b9-431f-42c1-b835-bd21678e2f4a