Medline Industries, Lp: Gynecological Laparoscopic Kit
Recall Summary Medline Industries is recalling gynecological laparoscopic kits (model DYNJT6105) that contain Bard Silastic Foley Catheters in sizes 16, 18, and 20 French with 5cc balloons. The catheters were recalled by the manufacturer because they have an increased amount of raw material on their surface, which may cause staining and could potentially be harmful. The affected kits were distributed nationwide, with primary distribution in California, Florida, Maryland, Pennsylvania, and Texas.
- Recalling firm
- Medline Industries, LP
- Product
- Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. NON MB DAVINCI LITHOTOMY SM PK DYNJT6105
- Reason
- Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-08
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of CA, FL, MD. PA, and TX.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/fbd58c32-e4bd-42f2-a39b-1ab1bcd8c35f