Medtronic Recalls Sterile O-Arm Drapes Due to Sterility Control Issues
Medtronic Navigation is recalling 26,674 sterile O-Arm drapes because returned devices were not adequately examined for damage to ensure sterility.
What this means for you
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 is classified as FDA Class II. The hazard involves a risk of harm (loss of sterility) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Medtronic Navigation, Inc. is recalling 26,674 units of DRAPE 9732722 TUBE STERILE O-ARM 20PK. These are single-use, disposable medical devices distributed nationwide. The recall involves specific lots: D120065, D121495, D121515, D120175, D122611, and D101555.
The recall was initiated because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage. This lack of control raises concerns about the ability to ensure the sterility of the devices.
Healthcare facilities and consumers should stop using these specific lots of sterile drapes. Users should check their inventory for the affected lot numbers and contact Medtronic Navigation for further instructions on how to return or dispose of the products.
The recalled product
- Product
- DRAPE 9732722 TUBE STERILE O-ARM 20PK
- Manufacturer
- Medtronic Navigation, Inc.
- Category
- Medical Device — Surgical Drapes
- Affected units
- 26,674
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)
- Lot No.: D120065 D121495 D121515 D120175 D122611 D101555
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 25 recalled by Medtronic Navigation, Inc. 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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