Medline Industries, Lp: Gynecological Laparoscopic Kit
Recall Summary Medline Industries is recalling gynecological laparoscopic kits (model DYNJ61206J) that contain Bard Silastic Foley Catheters in sizes 16, 18, and 20 French with 5cc balloons. The catheters have excess raw material on their surface that can cause staining and may be harmful if used. These 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. SM-LAPAROSCOPIC PROSTATE PAC DYNJ61206J
- 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/188be912-d799-496a-9b67-468fff0d2a8f