Medline Namic Guidewires Recall Due to Rescinded FDA Clearance
Medline Industries has issued a recall of Medline Namic Guidewires because their FDA 510(k) regulatory clearances have been rescinded. The affected units were distributed nationwide.
What this means for you
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 rescission of regulatory clearances. The source text states no illnesses or injuries have been reported, and the hazard is administrative (loss of clearance) rather than a safety defect with known adverse health consequences, making this a precautionary recall classified as Moderate.
Plain-English summary
Medline Industries, LP is recalling multiple models of Medline Namic Guidewires nationwide. The recall affects 74,085 units across 30 different product models, including various configurations of the GUIDEWIRE 3MMJ and GWIRE HYDRO product lines in 0.035 and 0.038 gauge sizes.
The guidewires are being recalled because their 510(k) regulatory clearances from the FDA have been rescinded. This means the devices no longer have approval to be marketed in the United States.
Healthcare facilities and practitioners who have these guidewires in stock should stop using them and consult with Medline Industries for further instructions regarding the affected lot numbers and model numbers listed in the recall details.
The recalled product
- Product
- Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT, Model Number: DYNJGWIRE20L; 2) GWIRE HYDRO 0.035 180CM ANG S, Model Number: DYNJHWIRE105; 3) GWIRE HYDRO 0.035 260CM ANG S, Model Number: DYNJHWIRE107; 4) GWIRE HYDRO 0.035 260CM STR S, Model Number: DYNJHWIRE115;
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Guidewires
- Hazard
- regulatory-clearance-rescission
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)
- 1) DYNJGWIRE20L
- UDI-DI: 10195327188955(each)
- 40195327188956(case)
- Lot Number: 34125030001
- 2) DYNJGWIRE20L
- Lot Number: 34125040001
- 3) DYNJGWIRE20L
- Lot Number: 25DBG562
- 4) DYNJGWIRE20L
- Lot Number: 25DBM956
- 5) DYNJHWIRE105
- UDI-DI: 10195327301637(each)
- 40195327301638(case)
- Lot Number: 34124110001
- 6) DYNJHWIRE105
- Lot Number: 24LBR925
- 7) DYNJHWIRE105
- Lot Number: 25IDB410
- 8) DYNJHWIRE107
- UDI-DI: 10195327302184(each)
Distribution
Distributed nationwide across the United States.
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