Medline Industries, Lp: Angiography/angioplasty Kit
Recall Summary Medline Industries is recalling two angiography/angioplasty kits (ANGIOGRAM PACK-LF and JUDKINS PACK) that contain 10mL syringes with unapproved design changes that were not included in the FDA's original clearance. These kits have been distributed nationwide across most U.S. states and Barbados. This is a Class II recall, meaning the products could cause serious health problems or fail to work as intended.
- Recalling firm
- Medline Industries, LP
- Product
- Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAM PACK-LF DYNJ21574J JUDKINS PACK DYNJ51126
- Reason
- Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-02-27
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI, WY and the country of Barbados.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/988959af-0570-441d-979d-6a1cbb7f60e0