Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing… — Class II medical device recall Z-1946-2026
Ongoing recall by Zimmer, Inc., reported 2026-05-06, distributed nationwide. Ten complaints have been received identifying issues at the time of use related to the package seal, including
| Recall number | Z-1946-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2026-03-30 |
| Classified | 2026-04-24 |
| Reported by FDA | 2026-05-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CL, MY, NZ |
| Quantity | 66,960 |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 00889024376564, 00889024379718 |
| Lot numbers | 82395238, 82395239, 82395240, 85390022, 85390023, 85390024, 85390025, 85390026, 85390027, 85390028, 85390029, 85682882, 86970970 |
| Model numbers | 00-5049-011-00, 00504901100 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1946-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.