Quick Facts at a Glance
- Recall Date
- March 30, 2026
- Hazard Level
- HIGH
- Brand
- Zimmer
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Zimmer
- Model numbers
- Lot Code: Model No. 00504901100, 20-Pack UDI (01)00889024379718(17)301014(10)85390029, Individual UDI (01)00889024376564(17)301014(10)85390029, Lot Number 85390029 Model No. 00504901100, 20-Pack UDI (01)00889024379718(17)301103(10)85682882, Individual UDI (01)00889024376564(17)301103(10)85682882, Lot Number 85682882 Model No. 00504901100, 20-Pack UDI (01)00889024379718(17)301001(10)85390028 +12 more
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 30, 2026
Reported by FDA DEVICE
May 6, 2026
RecallRadar source check
May 13, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Zimmer, Inc. or your healthcare provider for instructions
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Full Description
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. Quantity: 66960. 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.
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
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