Medtronic Recalls Clip Gun Scalp Clip Kits Due to Packaging Defects
Medtronic is voluntarily recalling specific Clip Gun Scalp Clip Kits and Applicators because they did not meet current packaging performance standards.
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: The recall is classified as FDA Class II and involves a voluntary precautionary action for packaging performance issues without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Medtronic Neurosurgery is initiating a voluntary recall of Model CG8900, CG8901, and CG8901A Clip Gun Scalp Clip Kits and Applicators. The recall involves 27,432.8 devices distributed across 33 countries and territories, including the United States, Canada, and various locations in Europe, Asia, and the Middle East.
The recall was initiated because the identified products did not adequately demonstrate acceptable packaging performance to current standards. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare facilities and distributors should check their inventory for the specific lot numbers listed in the official recall notice. If affected products are found, they should be removed from use and returned to Medtronic Neurosurgery according to their instructions.
The recalled product
- Product
- Model #: CG8900, Medtronic Clip Gun Scalp Clip Kit (Qty 1); Model #: CG8901, Medtronic Clip Gun Scalp Clip Kit (Qty 10); Model #: CG8901A, Medtronic Clip Gun Applicator (Qty 10)
- Manufacturer
- Medtronic Neurosurgery
- Hazard
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 (20)
- Affected Lots: D80412
- D84100
- E00008
- E00983
- E03049
- E03716
- E05806
- E07257
- E09145
- E14782
- E14896
- E15195
- E19181
- E19182
- E19183
- E19184
- E19868
- E20599
- E23631
- E33102
Distribution
Distributed in 1 state:
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