FDAClass II · Medical device · Recall Z-1946-2026 · Recalled May 6, 2026

Brand Name recall — Zimmer, Inc.

Agency report date: May 6, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Brand Name
Company / brand: Zimmer
Lot / serial / date codes: 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 ; Individual UDI (01)00889024376564(17)301001(10)85390028 ; Lot Number 85390028 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300422(10)82395239 ; Individual UDI (01)00889024376564(17)300422(10)82395239 ; Lot Number 82395239 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300423(10)82395240 ; Individual UDI (01)00889024376564(17)300423(10)82395240 ; Lot Number 82395240 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300929(10)85390027 ; Individual UDI (01)00889024376564(17)300929(10)85390027 ; Lot Number 85390027 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300924(10)85390026 ; Individual UDI (01)00889024376564(17)300924(10)85390026 ; Lot Number 85390026 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300415(10)82395238 ; Individual UDI (01)00889024376564(17)300415(10)82395238 ; Lot Number 82395238 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300922(10)85390025 ; Individual UDI (01)00889024376564(17)300922(10)85390025 ; Lot Number 85390025 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300826(10)85390022 ; Individual UDI (01)00889024376564(17)300826(10)85390022 ; Lot Number 85390022 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300918(10)85390024 ; Individual UDI (01)00889024376564(17)300918(10)85390024 ; Lot Number 85390024 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300722(10)85390023 ; Individual UDI (01)00889024376564(17)300722(10)85390023 ; Lot Number 85390023 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)310122(10)86970970 ; Individual UDI (01)00889024376564(17)310122(10)86970970 ; Lot Number 86970970
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.

Agency product description and boundaries

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

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: 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.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Brand Name recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-1946-2026
Brand: All Zimmer recalls
Classification: Class II
Units affected: 66,960
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Brand Name recall status

Companies & origin

Recalling firm location: Warsaw, IN, United States
Firm address: 1800 W Center St, 46580-2304

Identifying details (verbatim from the notice)

Product codes / lots: 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 ; Individual UDI (01)00889024376564(17)301001(10)85390028 ; Lot Number 85390028 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300422(10)82395239 ; Individual UDI (01)00889024376564(17)300422(10)82395239 ; Lot Number 82395239 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300423(10)82395240 ; Individual UDI (01)00889024376564(17)300423(10)82395240 ; Lot Number 82395240 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300929(10)85390027 ; Individual UDI (01)00889024376564(17)300929(10)85390027 ; Lot Number 85390027 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300924(10)85390026 ; Individual UDI (01)00889024376564(17)300924(10)85390026 ; Lot Number 85390026 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300415(10)82395238 ; Individual UDI (01)00889024376564(17)300415(10)82395238 ; Lot Number 82395238 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300922(10)85390025 ; Individual UDI (01)00889024376564(17)300922(10)85390025 ; Lot Number 85390025 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300826(10)85390022 ; Individual UDI (01)00889024376564(17)300826(10)85390022 ; Lot Number 85390022 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300918(10)85390024 ; Individual UDI (01)00889024376564(17)300918(10)85390024 ; Lot Number 85390024 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300722(10)85390023 ; Individual UDI (01)00889024376564(17)300722(10)85390023 ; Lot Number 85390023 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)310122(10)86970970 ; Individual UDI (01)00889024376564(17)310122(10)86970970 ; Lot Number 86970970
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.
FDA event ID: 98665
Recall initiated: March 30, 2026
FDA classified: April 24, 2026
FDA report date: May 6, 2026

Other medical device recalls from around the same time

Centimeter Sizing Catheter RPN N5 recall — Cook IncorporatedFDA · May 13, 2026
Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers recall — Intuitive Surgical, Inc.FDA · May 13, 2026
AIDBAGs are first aid kits of convenience composed of individually labeled devices designe recall — North American Rescue LLC.FDA · May 6, 2026
WHILL Model F recall — WHILL, INC.FDA · May 6, 2026
WHILL Model C2 recall — WHILL, INC.FDA · May 6, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved August 4, 2026 at 11:00 PM UTC.

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