FDA recall, , Moderate risk
Zimmer Disposable Mixing Bowls with Spatula
Disposable Mixing Bowls with Spatula may have incomplete or peeling seals, which could lead to infection.
Summary by Recall Canary from the FDA notice
What happened
Zimmer, Inc., of Warsaw, Indiana, recalled Disposable Mixing Bowls with Spatula, model 00-5049-011-00, after ten complaints identified issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeling seals. A compromised sterile barrier may lead to clinically insignificant extension of surgery or infection leading to surgical intervention.
The recall began March 30, 2026, and was added to the FDA's Enforcement Report on April 24, 2026. The product was distributed nationwide in the United States and in Canada, Australia, New Zealand, Malaysia, EMEA, and Chile.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and lot code listed under your product.
Mixing Bowl and Spatula
- Model number
- 00-5049-011-00
- Lot code
- 00504901100
- 20-Pack
- 85390029
- 85682882
- 85390028
- 82395239
- 82395240
- 85390027
- 85390026
- 82395238
- 85390025
- 85390022
- 85390024
- 85390023
- 86970970
Recall details
- Company began the recall
- Sold in
US Nationwide distribution including in the states of Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Washington, Wisconsin and the countries of Canada, Australia, New Zealand, Malaysia, EMEA, Chile.
- Company
- Zimmer, Inc.Warsaw, Indiana
- Hazard
- Sterility problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98665
- Recall number
- Z-1946-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
