Pelvic Exam Kit
Recall Summary Medline pelvic exam kits (model SMSC-PELVISCOPY PACK-LF, lot DYNJ0161619M) are being recalled because they contain a defective adhesive product made by Ferndale Laboratories. The adhesive's tubing may crack when used, making the product unable to function properly. The kits have been distributed nationwide across all U.S. states and Washington, D.C.
- Product
- Medline convenience kit: SMSC-PELVISCOPY PACK-LF DYNJ0161619M
- Reason
- Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-27
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution. OUS distribution pending.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/66d66894-2bdb-4963-adb3-d1434db4dafa