Zimmer, Inc. recalls Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula…
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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
Lot / code information
- Lot #
- Code:
- Model
- 00504901100 ; 20-Pack
- UDI
- (01)00889024379718(17)301014(10)85390029 ; Individual
- UDI
- (01)00889024376564(17)301014(10)85390029
- Lot #
- 85390029
- Model
- 00504901100 ; 20-Pack
- UDI
- (01)00889024379718(17)301103(10)85682882 ; Individual
- UDI
- (01)00889024376564(17)301103(10)85682882
- Lot #
- 85682882
- Model
- 00504901100 ; 20-Pack
- UDI
- (01)00889024379718(17)301001(10)85390028 ; Individual
- UDI
- (01)00889024376564(17)301001(10)85390028
- Lot #
- 85390028
- Model
- 00504901100 ; 20-Pack
- UDI
- (01)00889024379718(17)300422(10)82395239 ; Individual
- UDI
- (01)00889024376564(17)300422(10)82395239
- Lot #
- 82395239
- Model
- 00504901100 ; 20-Pack
- UDI
- (01)00889024379718(17)300423(10)82395240 ; Individual
- UDI
- (01)00889024376564(17)300423(10)82395240
- Lot #
- 82395240
- Model
- 00504901100 ; 20-Pack
- UDI
- (01)00889024379718(17)300929(10)85390027 ; Individual
- UDI
- (01)00889024376564(17)300929(10)85390027
- Lot #
- 85390027
- Model
- 00504901100 ; 20-Pack
- UDI
- (01)00889024379718(17)300924(10)85390026 ; Individual
- UDI
- (01)00889024376564(17)300924(10)85390026
- Lot #
- 85390026
- Model
- 00504901100 ; 20-Pack
- UDI
- (01)00889024379718(17)300415(10)82395238 ; Individual
- UDI
- (01)00889024376564(17)300415(10)82395238
- Lot #
- 82395238
- Model
- 00504901100 ; 20-Pack
- UDI
- (01)00889024379718(17)300922(10)85390025 ; Individual
- UDI
- (01)00889024376564(17)300922(10)85390025
- Lot #
- 85390025
- Model
- 00504901100 ; 20-Pack
- UDI
- (01)00889024379718(17)300826(10)85390022 ; Individual
- UDI
- (01)00889024376564(17)300826(10)85390022
- Lot #
- 85390022
- Model
- 00504901100 ; 20-Pack
- UDI
- (01)00889024379718(17)300918(10)85390024 ; Individual
- UDI
- (01)00889024376564(17)300918(10)85390024
- Lot #
- 85390024
- Model
- 00504901100 ; 20-Pack
- UDI
- (01)00889024379718(17)300722(10)85390023 ; Individual
- UDI
- (01)00889024376564(17)300722(10)85390023
- Lot #
- 85390023
- Model
- 00504901100 ; 20-Pack
- UDI
- (01)00889024379718(17)310122(10)86970970 ; Individual
- UDI
- (01)00889024376564(17)310122(10)86970970
- Lot #
- 86970970
Show 43 more code fieldsShow fewer
What the firm is doing
On March 30, 2026, the firm began notifying customers via letters titled "URGENT MEDICAL DEVICE RECALL." Risk Managers were instructed to notify affected personnel and locate and quarantine affected product in inventory. A Zimmer Biomet sales representative may remove and return the affected product on your behalf, or the customer may choose to directly return all affected product from their facility. Surgeons were informed that there are no specific patient-monitoring instructions recommended beyond existing follow up schedules.
DistributionShow detailsHide
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.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1946-2026
- FDA device classification · JDZOfficial FDA classification for this device type
- CFR regulation · 21 CFR 888.4210The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Zimmer, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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