Medline Industries, Lp: Gynecological Laparoscopic Kit
Recall Summary Medline Industries is recalling gynecological laparoscopic kits (DAVINCI PROSTATE PACK models DYNJ68477L and DYNJ68477M) because they contain Bard Silastic Foley Catheters with excess raw material on the catheter surface. This excess material may cause staining and potentially be harmful to patients. The 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. DAVINCI PROSTATE PACK DYNJ68477L DYNJ68477M
- 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/fbf9727a-d370-467a-9d80-f9ec2f145d30