Zimmer, Inc.: Brand Name: Disposable Mixing Bowls With Spatula Product Name: Mixing Bowl And Spatula Model/catalog Number: 00-5049-011-00 Software Version: N/a P...
Recall Summary Zimmer, Inc. is recalling disposable mixing bowls with spatulas (Model 00-5049-011-00) because the package seals may be incomplete, wrinkled, or peeling, which can compromise the sterile barrier. Ten complaints have been received about seal issues during use. These products were distributed nationwide across the US, Canada, Australia, New Zealand, Malaysia, Chile, and other regions.
- Recalling firm
- Zimmer, Inc.
- Product
- Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011-00 Software Version: N/A Product Description: Mixing Bowl and Spatula Component: N/A
- Reason
- Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeling seals. Compromised sterile barrier may lead to clinically insignificant extension of surgery or infection leading to surgical intervention.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-03-30
- Status
- Ongoing
- 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, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, MI, MO, MS, NC, NE, NM, NY, OH, OK, PA, SD, TN, TX, UT, WA, WI and the countries of Canada, Australia, New Zealand, Malaysia, EMEA, Chile.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/229fb3fc-f2d0-4a3d-99c8-a9fdbeb5809f