CLASS II ONGOING Device recall · Reported 22 Jul 2026 · FDA Enforcement Report
Medline Kits containing Zimmer Biomet mixing bowls recalled
Medline Industries is recalling Medline Kits containing Zimmer Biomet mixing bowls and spatulas Total Knee Pack DYNJT6267, distributed nationwide in the US. The recall was initiated on 10 Jun 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2736-2026
- FDA event ID
- 99318
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Jun 2026
- FDA classified
- 15 Jul 2026
- Reported
- 22 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 10 Jun 2026 | Recall initiated by company | |
| 15 Jul 2026 | Classified by FDA | +35 days |
| 22 Jul 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267
Where it was distributed
US Nationwide distribution in the states of CA and UT.
Questions about this recall
Is Medline Kits containing Zimmer Biomet mixing bowls and spatulas Total Knee Pack DYNJT6267 recalled?
Yes. Medline Industries recalled Medline Kits containing Zimmer Biomet mixing bowls and spatulas Total Knee Pack DYNJT6267 on 10 Jun 2026. The recall is Class II and its status is Ongoing. Recall number Z-2736-2026.
Why was it recalled?
Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.
Which lots are affected?
UDI-DI 10198459538827 Kit Lots 26DMB644 26CMC467
Where was it sold?
US Nationwide distribution in the states of CA and UT.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |