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Lower risk Medical device recall · FDA · Published March 30, 2026

Zimmer Disposable Mixing Bowls with Spatula Recall: Package Seal Issues

Zimmer recalls 20-pack disposable mixing bowls with spatulas due to potential package seal failures that could compromise sterile barriers during surgery.

🇺🇸 FDA recall #Z-1946-2026Medical deviceZimmer ›
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Recalling firmZimmer, Inc.1800 W Center St · Warsaw, IN 46580-2304
✎ GovInfoNow plain-language explainer

Zimmer is recalling disposable mixing bowls with spatulas because their package seals may be incomplete, wrinkled, or peeling. This could lead to surgical infections or extended procedures if the sterile barrier is compromised during surgery. Read more at govinfonow.com/recall/49582-zimmer-disposable-mixing-bowls-with-spatula-recall-package-seal-issues.

Source Summary by GovInfoNow · govinfonow.com/recall/49582-zimmer-disposable-mixing-bowls-with-spatula-recall-package-seal-issues · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1946-2026

Cite this page

“Zimmer Disposable Mixing Bowls with Spatula Recall: Package Seal Issues.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/49582-zimmer-disposable-mixing-bowls-with-spatula-recall-package-seal-issues. Based on FDA recall #Z-1946-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1946-2026%22&limit=1).

The FDA announced on March 30, 2026, that Zimmer, Inc. is recalling Mixing Bowl and Spatula products due to compromised sterile barriers. The hazard includes incomplete or peeling seals that may lead to infection requiring surgical intervention.

How to tell if you have it

  • Brand: Zimmer
  • Product Name: Mixing Bowl and Spatula
  • Model/Catalog Number: 00-5049-011-00
  • UPC: 00889024376564
  • UPC: 00889024379718

The hazard

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. A compromised sterile barrier may lead to clinically insignificant extension of surgery or infection leading to surgical intervention.

Context

GovInfoNow's records show Zimmer, Inc. has 19 other recalls on record since August 25, 2022. Recent brand recalls include the May 20, 2026 Off-Axis Alliance Glenoid Reamer Guide Recall for plastic guide breakage risk and the May 11, 2026 Persona Revision Femoral Distal Augment Recall for a posterior augment found in a package. Other recent recalls of similar products include the June 12, 2026 Medline Convenience Kits Recall for microbial contamination from packaging wrinkles and the November 13, 2025 Medline 5.5" Sterile Scissors Recall for weak packaging risk of infection.

How to tell if you have this one

Look for the model number 00504901100 on the packaging. These 20-packs were sold with specific lot numbers including 85390028, 85390029, 85682882, and others listed in the recall notice.

  • Brand
    Zimmer
  • Product
    Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Package Seal

    Inspect the package seal for completeness, wrinkles, or peeling. If the seal is compromised, do not use the product.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 31 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Michigan, Mississippi, Missouri, Nebraska, New Mexico, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Washington, Wisconsin.

Recall timeline

FDA published this recall 37 days after the firm started it.

1. Firm started the recall: Mar 30, 202612. FDA classified it Class II: Apr 24, 202623. Published in FDA’s Enforcement Report: May 6, 202632026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1946-2026 (March 30, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1946-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA