Amendia Dual Stylet Needle Recall Due to Unacceptable Packaging Seals
Amendia, Inc. is recalling 1,078 Dual Stylet Needles because packaging seals are compromised by channels or voids, potentially affecting product integrity.
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, but the source text describes a packaging integrity issue (unacceptable seals) without reporting any injuries, illnesses, or specific functional failures of the device itself, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Amendia, Inc. is recalling 1,078 units of Dual Stylet Needles, Part Number 812-11R-15. The recall is due to packaging defects where the seals are unacceptable, with some seals compromised by channels or voids.
The affected products were distributed nationwide to 26 states and Puerto Rico. The recall covers specific lot numbers including 121945, 123231, 124146, 125418, 126822, 127868, 128459, 128464, 130818, 131492, 13496, 132594, 132813, 134514, 134515, 134517, 134909, 135290, and 137302.
Healthcare facilities and consumers should stop using these needles and contact Amendia, Inc. for further instructions or a replacement. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone
- Manufacturer
- Amendia, Inc
- Affected units
- 1,078
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 (19)
- Part Number 812-11R-15 Lot Number 121945
- 123231
- 124146
- 125418
- 126822
- 127868
- 128459
- 128464
- 130818
- 131492
- 13496
- 132594
- 132813
- 134514
- 134515
- 134517
- 134909
- 135290
- 137302
Distribution
Part of a larger recall action
This product is one of 3 recalled by Amendia, 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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