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-lf, 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-2737-2026
- 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-LF DYNJ61651J
Where it was distributed
US Nationwide distribution in the states of CA and UT.
Questions about this recall
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 10195327388447 Kit Lot 26DME172
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 99318This product is part of a recall event; the main page for the event is Medline Kits containing Zimmer Biomet mixing bowls recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Medline Kits containing Zimmer Biomet mixing bowls recalled | Medline Industries | Sterility | Nationwide |
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