Medtronic Recalls Best Practice Kits Due to Potential Seal Defects
Medtronic is recalling Best Practice Kits because an incomplete seal may cause the suture material to degrade prematurely.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Medtronic is recalling Best Practice Kits, including item numbers 00Z2064, 00Z2150, 00Z2190, 00Z2192, 00Z2211, 00Z2212, 00Z2216, 00Z2217, and 00Z2312. The recall involves a total of 478,465 units.
The recall was initiated due to a potential for an incomplete seal on the inner package. This defect may result in the premature degradation of the suture material contained within the kits.
The affected products were distributed worldwide, including the United States (nationwide and Puerto Rico) and specific countries such as Australia, Belgium, Canada, Chile, China, Israel, Italy, Japan, South Korea, Mexico, Panama, Saudi Arabia, Singapore, and Turkey. Users should stop using the affected kits and contact Medtronic for further instructions.
The recalled product
- Product
- Best Practice Kit, Item Numbers: 00Z2064, 00Z2150, 00Z2190, 00Z2192, 00Z2211, 00Z2212, 00Z2216, 00Z2217, 00Z2312
- Manufacturer
- Medtronic
- Affected units
- 478,465
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)
- N/A
Distribution
Part of a larger recall action
This product is one of 8 recalled by Medtronic 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.
See all 8 products in this recall →Related recalls
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