Medline Kits with Zimmer Biomet Mixing Bowls and Spatulas Recalled
Medline Industries is recalling 163 kits containing Zimmer Biomet mixing bowls and spatulas due to seal defects that risk sterility breach during surgical procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a potential sterility breach with no reported illnesses or injuries. The source text explicitly characterizes health consequences as "clinically insignificant," making this a low-risk scenario that falls under the Moderate category.
Plain-English summary
Medline Industries, LP is recalling Medline Kits containing Zimmer Biomet mixing bowls and spatulas (Kit Lot 26DME172, UDI-DI 10195327388447). The recall affects 163 kits distributed nationwide in California and Utah.
The kits are being recalled due to seal nonconformities that present a risk of sterility breach. Use of the recalled product may require clinically insignificant extension of surgery to locate another readily available device.
Healthcare facilities and surgical centers that received these kits should cease use and contact Medline Industries for replacement or return instructions.
The recalled product
- Product
- Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK-LF DYNJ61651J
- Manufacturer
- Medline Industries, LP
- Affected units
- 163
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI 10195327388447 Kit Lot 26DME172
Distribution
Part of a larger recall action
This product is one of 2 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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